Search results from the Australian New Zealand Clinical Trials Registry

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Search Parameters
Keyword: Cholangiocarcinoma
Broad Health Condition: Cancer
Specific Condition: Biliary tree (gall bladder and bile duct)
Recruitment Status: Recruiting

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Adjuvant chemotherapy with gemcitabine and cisplatin compared to standard of care after curative intent resection of cholangiocarcinoma and muscle invasive gallbladder carcinoma (ACTICCA-1 trial)

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Trial Information

Trial summary

The purpose of this study is to determine whether or not treating patients with cisplatin and gemcitabine chemotherapy helps reduce the risk of cancer returning. 
Who is it for?
ACTICCA-1 is a clinical research study for people who have a cancer of the biliary tract (cancer of the gall bladder or bile duct, also known as cholangiocarcinoma in medical terms) which has been removed in an operation.
Study details
These drugs are being tested as they have been shown to be the most effective chemotherapy combination in more advanced cases of biliary tract cancer, where the disease is inoperable or has spread to other areas of the body.
This is an international investigator initiated study called ACTICCA-1, which is being led by the University Medical Centre Hamburg- Eppendorf in Germany and conducted in Australia by the Australasian Gastro-Intestinal Trials Group (AGITG) in collaboration with the National Health and Medical Research Centre Clinical Trials Centre (NHMRC CTC), University of Sydney.
The study involves randomly allocating participants to receive either chemotherapy with cisplatin and gemcitabine or the current standard of care (capecitabine). The drugs used in this study are approved in Australia to treat various cancers, however they do not have a specific listing by the Australian Therapeutics Goods Administration (TGA) for biliary tract cancer
The total duration of the study is 5 years. 
It is hoped that the findings of this study will provide details on whether giving cisplatin and gemcitabine chemotherapy following surgery for cancer of the biliary tract is a safe and effective treatment to reduce the chance of disease progression and increase survival time and quality of life.

Broad Health Conditioncholangiocarcinoma
muscle invasive gallbladder carcinoma

Specific Health ConditionCancer
Biliary tree (gall bladder and bile duct)

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW,QLD,SA,WA

Hospital
Bankstown-Lidcombe Hospital - Bankstown

Hospital
Royal Brisbane & Womens Hospital - Herston

Hospital
Flinders Medical Centre - Bedford Park

Hospital
Nepean Hospital - Kingswood

Hospital
Calvary Mater Newcastle - Waratah

Hospital
The Townsville Hospital - Douglas

Hospital
Prince of Wales Hospital - Randwick

Hospital
Princess Alexandra Hospital - Woolloongabba

Hospital
Sir Charles Gairdner Hospital - Nedlands

Hospital
St John of God Hospital, Subiaco - Subiaco

Hospital
St George Hospital - Kogarah

Hospital
Fiona Stanley Hospital - Murdoch

Postcode
2747 - Kingswood

Postcode
2298 - Waratah

Postcode
4814 - Douglas

Postcode
2031 - Randwick

Postcode
4102 - Woolloongabba

Postcode
6009 - Nedlands

Postcode
6008 - Subiaco

Postcode
2217 - Kogarah

Postcode
6150 - Murdoch

Trial location outside Australia

Country
Germany

Country
Netherlands

Country
United Kingdom

Anticipated date of first participant enrolment1/12/2015

Anticipated date of last participant enrolment1/09/2020

Phase of TrialPhase 3

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

* Histologically confirmed adenocarcinoma of biliary tract (intrahepatic, hilar or extrahepatic cholangiocarcinoma or muscle invasive gallbladder carcinoma) after radical surgical therapy with macroscopically complete resection (mixed tumour entities (HCC/CCA) are excluded)
* Macroscopically complete resection (R0/1) within 6 (-16) weeks before scheduled start of chemotherapy
*ECOG 0-1
*Age greater than 18 years
* Adequate hematologic function: ANC greater than or equal to 1.5 x 10*9/L, platelets greater than or equal to 100 x 10*9/L, haemoglobin greater than or equal to 9 grams/dl or greater than or equal to 5.59 mmol/L
* Adequate liver function as measured by serum transaminases (AST and ALT) less than or equal to 5xULN and bilirubin less than or equal to 3xULN
*Adequate renal function, ie. serum creatinine less than or equal to 1.5xULN, glomerular filtration rate greater than or equal to 60mL/min (MDRD)
* No active uncontrolled infection, except chronic viral hepatitis under antiviral therapy
* No concurrent treatment with other experimental drugs or other anti-cancer therapy, treatment in a clinical trial within 30 days prior to randomisation
* Negative serum pregnancy test within 7 days of starting study treatment in pre-menopausal women and women less than 1 year after the onset of menopause (Note: a negative test has to be reconfirmed by a urine test, should the 7 day window be exceeded)
* Written informed consent

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

* Prior chemotherapy for biliary tract cancer
* Previous malignancy within 3 years or concomitant malignancy, except: those with a 5 year overall survival rate of more than 90% e.g non-melanomatous skin cancer or adequately treated in-situ cervical cancer 
* Severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or IV, unstable angina pectoris, history of myocardial infarction in the last 3 months, significant arrhythmia
* Presence of psychiatric disorder precluding understanding of information of trial related topics and giving informed consent
* Serious underlying medical conditions (judged by the investigator), that could impair the ability of the patient to participate in the trial
* Fertile women (less than 1 year after last menstruation) and procreative men unwilling and unable to use effective means of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile)
* Pregnancy or lactation
Contact details and further information

Sponsor Primary Sponsor Type: Other Collaborative groups
Primary Sponsor Name: Australasian Gastro-Intestinal Trials Group
Primary Sponsor Address: GI Cancer Institute Lifehouse, Level 6 119-143 Missenden Road Camperdown NSW 2050
Primary Sponsor Country: Australia

Trial IDACTRN12615001283561

Contact person for information and recruitmentMs
ACTICCA-1 Trial Coordinator
Lifehouse Level 6 119-143 Missenden Road Camperdown NSW 2050
+612 9562 5000

Further information iconActicca1@ctc.usyd.edu.au
Australia

A Beta-only IL-2 ImmunoTherapY (ABILITY) Study

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Trial Information

Trial summary

This is a Phase 1/2, multi-center, open-label, dose-escalation and expansion study to
evaluate safety and tolerability, PK, pharmacodynamic, and early signal of anti-tumor
activity of MDNA11 alone or in combination with a checkpoint inhibitor in patients with
advanced solid tumors.

Broad Health ConditionIL-2
IL2
Interleukin-2
cancer
metastatic
RCC
TNBC
PDA
NSCLC
CRC
GEJ
intrahepatic
extrahepatic
MCC
SCCHN
CSCC
Gastroesophageal Junction
advanced
unresectable
Cholangiocarcinoma

Specific Health ConditionCancer
Advanced Solid Tumor
Unresectable Solid Tumor
Melanoma
Renal Cell Carcinoma
Sarcoma
Triple Negative Breast Cancer
Pancreatic Ductal Adenocarcinoma
Non-Small Cell Lung Cancer Squamous
Non-Small Cell Lung Cancer Non-squamous
Colorectal Cancer
Gastric Cancer
Biliary Tract Cancer
Gallbladder Cancer
Cholangiocarcinoma
Uterine Cancer
Ovarian Cancer
Cervical Cancer
Basal Cell Carcinoma
Bladder Cancer
Merkel Cell Carcinoma
Squamous Cell Carcinoma of Head and Neck
Cutaneous Squamous Cell Carcinoma

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW,QLD,

Phase of TrialPhase 1/Phase 2

Eligibility

Key inclusion criteria

Key Inclusion Criteria:

    1. Aged at least 18 years (inclusive at the time of informed consent).

    2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.

    3. Must be able and willing to provide written informed consent prior to start of any
       study procedures and assessments and must be willing to comply with all study
       procedures.

    4. Histologically or cytologically confirmed locally advanced or metastatic solid tumor
       that is unresectable (see tumor types listed under conditions)

    5. Demonstrated adequate organ function

    6. Measurable disease as per Response Evaluation Criteria in Solid Tumors, (RECIST v1.1)
       and documented by CT and/or MRI.

    7. Life expectancy of = 12 weeks.

    8. Women of childbearing potential (WOCBP) must have a negative pregnancy test at
       screening and within 72 hours before the first dose of study drug(s). Women must not
       be breastfeeding.

    9. Agree to use highly effective contraception methods. WOCBP must agree to use highly
       effective birth control

  Key Exclusion Criteria:

    1. Received anticancer therapy within 28 days prior to the first dose of study drug(s).

    2. Has carcinomatous meningitis or leptomeningeal disease; stable CNS metastases
       permitted based on Medical Monitor review.

    3. Active malignancy (other than the disease under treatment in the study) within the
       previous 3 years except for curable cancers

    4. Clinically significant active, known or suspected autoimmune disease, or diseases that
       can be exacerbated with immunotherapy.

    5. Severe pulmonary, cardiac or other systemic disease.

    6. Females who are pregnant or lactating or planning to become pregnant during the study.

    7. Active infection requiring systemic therapy.

    8. Any medical, emotional or psychiatric condition that interfere with the patient's
       ability to adhere to the protocol

    9. Any other underlying medical conditions that, in the Investigator's opinion, will make
       the administration of study drug(s) unsafe or obscure the interpretation of toxicity
       determination or adverse events.

   10. Known severe hypersensitivity to any component of study drug(s).

   11. Prior Interleukin therapy.

   12. Inability to comply with study and follow up procedures as judged by the Investigator.

Minimum age18 Years

GenderAll

Can Healthy volunteers participate?No

Contact details and further information

Sponsor Primary Sponsor Type: Commercial sector/Industry
Primary Sponsor Name: Medicenna Therapeutics, Inc.

Trial websitehttps://clinicaltrials.gov/show/NCT05086692

Trial IDNCT05086692








Combination Immunotherapy in Rare Cancers Under InvesTigation

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Trial Information

Trial summary

The four tumour streams that will be studied in this protocol are based on immunotherapy
sensitive rare cancers from CA209-538 which will be further investigated under this protocol
and divided into four groups:

  1. Neuroendocrine cancers: Atypical bronchial carcinoid, neuroendocrine carcinoma and Grade
     3 NETs independent of primary site (SCLC excluded)

  2. Biliary tract cancers: Intrahepatic cholangiocarcinoma and gallbladder carcinoma

  3. Gynaecological malignancies: Ovarian clear cell carcinoma, uterine clear cell carcinoma,
     uterine/ovarian carcinosarcoma, uterine leiomyosarcoma and vaginal/vulva squamous cell
     carcinoma

  4. Mismatch repair protein deficient (MSI-H) cancers (excluding colorectal carcinoma).

The role of immunotherapy is being defined in more common cancer types, however because of
their rarity, the efficacy of immunotherapy for these cancers is poorly defined.

This protocol provides an important opportunity to establish whether the combination of
nivolumab & ipilimumab has efficacy in these cancers.

Broad Health Condition

Specific Health ConditionCancer
Advanced Biliary Tract Cancer
Neuroendocrine Tumors
Female Reproductive System Neoplasm
MSI-H Solid Malignant Tumor

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW,VIC,

Hospital
Blacktown Hospital

Phase of TrialPhase 2

Eligibility

Key inclusion criteria

Inclusion Criteria:

    1. Signed Written Informed Consent

         -  Subjects must be willing and able to comply with scheduled visits, treatment
            schedule, laboratory testing, and other requirements of the study

    2. Target Population

         -  a) Histologically confirmed Neuroendocrine cancers: Atypical bronchial carcinoid,
            neuroendocrine carcinoma and Grade 3 NETs independent of primary site (SCLC
            excluded); Biliary Tract Cancers: Intrahepatic cholangiocarcinoma, gallbladder
            carcinoma; Gynaecological malignancies: Ovarian clear cell carcinoma, uterine
            clear cell carcinoma, uterine/ovarian carcinosarcoma, uterine leiomyosarcoma,
            vaginal/vulva squamous cell carcinoma; Mismatch repair protein deficient (MSI-H)
            cancers (excluding colorectal carcinoma)

         -  Eastern Cooperative Oncology Group (ECOG) performance status of =1

         -  Prior systemic therapy (=1) for advanced disease is permitted if it was completed
            at least 4 weeks prior to enrolment, and all related adverse events have either
            returned to baseline or stabilized or participants are not suitable for, or if
            declining established standard therapies. For MSI-H rare cancers and atypical
            bronchial carcinoid only, patients will be eligible independent of the number of
            prior lines of systemic treatment received as long as treatment has been
            completed at least 4 weeks prior to enrolment.

         -  Prior radiotherapy must have been completed at least 2 weeks prior to study drug
            administration.

         -  Measurable disease by CT or MRI per RECIST 1.1 criteria

         -  Tumour tissue from an unresectable or metastatic site of disease must be
            available for biomarker analyses.

         -  Screening laboratory values must meet the following criteria and should be
            obtained within 14 days prior to randomization:

              -  WBC (white blood cells) > or = to 2000/µL

              -  Neutrophils > or = to 1500/µL

              -  Platelets > or = to 100 x103/µL

              -  Hemoglobin > 9.0 g/dL

              -  Serum creatinine < or = to 1.5 x ULN or creatinine clearance (CrCl) 40
                 mL/min (using the Cockcroft-Gault formula)

              -  AST/ALT (aspartate transaminase/alanine transaminase) < or = to 3 x ULN (in
                 the event of metastatic liver disease, an exception to this upper limit may
                 be accepted in consultation with the study physician).

              -  Total Bilirubin < or = to 1.5 x ULN (Upper limit of normal) (except subjects
                 with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL).

         -  Subject Re-enrolment: This study permits the re-enrolment of a subject that has
            discontinued the study as a pre-treatment failure (i.e. subject has not been
            treated) after obtaining agreement from the medical monitor prior to re enrolling
            a subject. If re-enrolled, the subject must be re-consented.

    3. Age and Reproductive Status

         -  Men and women, > or = to 18 years of age

         -  Women of childbearing potential (WOCBP) must use method(s) of contraception.
            WOCBP should therefore use an adequate method to avoid pregnancy for 23 weeks (30
            days plus the time required for Nivolumab to undergo five half lives) after the
            last dose of investigational drug.

         -  Women must have a negative serum or urine pregnancy test (minimum sensitivity 25
            IU/L or equivalent units of HCG) within 24 hours prior to the start of
            investigational product.

         -  Women must not be breastfeeding

         -  Men who are sexually active with WOCBP must use any contraceptive method with a
            failure rate of less than 1 percent per year. Men that are sexually active with
            WOCBP must follow instructions for birth control when the half life of the
            investigational drug is greater than 24 hours, contraception should be continued
            for a period of 90 days plus the time required for the investigational drug to
            undergo five half lives. The half life of nivolumab and ipilimumab is up to 25
            days and 18 days, respectively. Given the blinded nature of the study, men who
            are sexually active with WOCBP must continue contraception for 31 weeks (90 days
            plus the time required for nivolumab to undergo five half lives) after the last
            dose of investigational drug.

         -  Women who are not of childbearing potential (i.e. who are postmenopausal or
            surgically sterile and azoospermic men do not require contraception.

  Exclusion Criteria:

    1. Target Disease Exceptions

         -  Active brain metastases or leptomeningeal metastases. Subjects with brain
            metastases are eligible if these have been treated and there is no magnetic
            resonance imaging (MRI except where contraindicated in which CT scan is
            acceptable) evidence of progression for at least 8 weeks after treatment is
            complete and within 28 days prior to first dose of study drug administration.
            Cases should be discussed with the medical monitor. There must also be no
            requirement for immunosuppressive doses of systemic corticosteroids (> 10 mg/day
            prednisone equivalents) for at least 2 weeks prior to study drug administration.

    2. Medical History and Concurrent Diseases

         -  Prior combination treatment directed against the PD-1/PDL1 (Programmed Death
            Ligand 1) axis (anti PD 1, anti PD-L1, anti PD L2), and anti CTLA 4 antibody.
            Prior monotherapy with these agents or other immune-stimulating/regulating agents
            is permitted.

         -  Any serious or uncontrolled medical disorder that, in the opinion of the
            investigator, may increase the risk associated with study participation or study
            drug administration, impair the ability of the subject to receive protocol
            therapy, or interfere with the interpretation of study results.

         -  Prior malignancy active within the previous 3 years except for locally curable
            cancers that have been apparently cured, such as basal or squamous cell skin
            cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix,
            or breast.

         -  Subjects with active, known or suspected autoimmune disease. Subjects with
            vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune
            condition only requiring hormone replacement, psoriasis not requiring systemic
            treatment, or conditions not expected to recur in the absence of an external
            trigger are permitted to enroll.

         -  Subjects with a condition requiring systemic treatment with either
            corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive
            medications within 14 days of study drug administration. Inhaled or topical
            steroids, and adrenal replacement doses > 10 mg daily prednisone equivalents are
            permitted in the absence of active autoimmune disease.

    3. Physical and Laboratory Test Findings

         -  Any positive test result for hepatitis B virus or hepatitis C virus indicating
            acute or chronic infection

         -  Known history of testing positive for human immunodeficiency virus (HIV) or known
            acquired immunodeficiency syndrome (AIDS).

    4. Allergies and Adverse Drug Reaction

         -  History of allergy to study drug components.

         -  History of severe hypersensitivity reaction to any monoclonal antibody.

    5. Sex and Reproductive Status

         -  WOCBP who are pregnant or breastfeeding

         -  Women with a positive pregnancy test at enrolment or prior to administration of
            study medication.

    6. Other Exclusion Criteria

         -  Prisoners or subjects who are involuntarily incarcerated

         -  Subjects who are compulsorily detained for treatment of either a psychiatric or
            physical (e.g. infectious disease) illness.

Minimum age18 Years

GenderAll

Can Healthy volunteers participate?No

Contact details and further information

Sponsor Primary Sponsor Type: Other
Primary Sponsor Name: Olivia Newton-John Cancer Research Institute

Trial websitehttps://clinicaltrials.gov/show/NCT04969887

Trial IDNCT04969887








A Phase I Study of WM-S1-030 in Patients With Advanced Solid Tumors

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Trial Information

Trial summary

This study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and
efficacy of WM-S1-030 in patients with advanced solid tumors.

Broad Health Condition

Specific Health ConditionCancer
Advanced Solid Tumor
Metastatic Solid Tumor
Colorectal Cancer
Lung Cancer
Pancreatic Cancer
Cholangiocarcinoma
Head and Neck Cancer

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
VIC,WA,

Phase of TrialPhase 1

Eligibility

Key inclusion criteria

Inclusion Criteria:

    1. Aged =18 years.

    2. Able and willing to sign the informed consent form (ICF).

    3. Have at least 1 evaluable lesion based on Response Evaluation Criteria in Solid Tumors
       (RECIST) v1.1.

    4. Have histologically or cytologically confirmed locally advanced unresectable or
       metastatic solid tumor which has progressed after treatment with standard therapies
       and for which no effective standard therapy is available or patient has refused, has a
       contraindication, or is intolerant to standard therapies.

    5. Have Eastern Cooperative Oncology Group (ECOG) performance status =2.

    6. Must have archived frozen tissue available (collected within 3 months before
       screening) or consent to a pre-treatment biopsy.

    7. Must be willing to consent to up to 2 on-treatment biopsies.

    8. Have a life expectancy of at least 12 weeks.

    9. Have adequate hematological functions and blood coagulation.

   10. Have adequate hepatic function at screening.

   11. Have adequate renal function at screening.

   12. QT interval corrected for heart rate using Fridericia's method =470 msec.

   13. Agree to abide by contraception requirements.

  Exclusion Criteria:

    1. Have received any cytotoxic chemotherapy, investigational agent (or medical device),
       anticancer drug, hormone therapy, or radiation therapy for treatment within 4 weeks or
       therapeutic radiopharmaceuticals taken within 8 weeks prior to the first
       administration of IP.

    2. Have known hypersensitivity to WM-S1-030 and/or excipient.

    3. Have = Grade 2 unresolved toxicity related to prior anticancer therapy excluding
       alopecia.

    4. Have received drugs or herbal supplements within 2 weeks prior to the first
       administration of IP which are known to be inhibitors or inducers of cytochrome P450
       (CYP) 3A4 including, but not limited to, cannabinoids, ketoconazole, itraconazole,
       posaconazole, voriconazole, rifampicin, phenytoin, St. John's Wort, carbamazepine, or
       hyperforin.

    5. Have any primary central nervous system (CNS) tumors or known CNS metastases unless
       clinically stable.

    6. Have previously undergone drainage of ascites and/or pleural effusion within 4 weeks
       prior to screening, or have clinically significant effusions at screening.

    7. Have had major surgery within 4 weeks prior to the first administration of IP.
       Patients should have recovered from the effects of major surgery or significant
       traumatic injury within 14 days prior to administration of the IP.

    8. Have serious non-healing wounds, ulcers, or bone fractures, except for traumatic
       fractures not requiring surgical intervention.

    9. Have an active infection treated with systemic anti-infectives within 2 weeks prior to
       the first administration of IP.

   10. Have concurrent unstable or uncontrolled systemic diseases.

   11. Have a history of gastrointestinal or trachea-esophageal fistulas.

   12. Current (or planned) pregnancy or breastfeeding from screening to at least 3 months
       following the last IP administration.

   13. Any condition, at the discretion of the investigator, which puts the patient at risk
       to participate in the study.

Minimum age18 Years

GenderAll

Can Healthy volunteers participate?No

Contact details and further information

Sponsor Primary Sponsor Type: Commercial sector/Industry
Primary Sponsor Name: Wellmarker Bio

Trial websitehttps://clinicaltrials.gov/show/NCT04801095

Trial IDNCT04801095








Recurrence After Whipple's (RAW) Study: Investigating Recurrence Patterns After Pancreaticoduodenectomy for Pancreatic, Ampullary or Distal Bile Duct Cancer

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Trial Information

Trial summary

Pancreatic head malignancies are aggressive cancers that are often inoperable when they are
diagnosed. In the ~20% of patients who are diagnosed when the disease is still operable,
surgery is the only treatment that can provide a chance of cure. Unfortunately, up to 75% of
patients undergoing surgery will have the cancer come back (recur). One of the reasons for
this is the challenge of removing the whole tumour with some surrounding non-cancerous tissue
to ensure that every tumour cell has been removed. This is difficult because there are many
structures very close to the pancreas (such as the blood vessels that supply the intestines)
that cannot be removed. A recent review study of >1700 patients who had a Whipple's operation
(the cancer operation that is performed to remove the head of pancreas) and found that whilst
the majority of patients had cancer recurrence in distant sites (like the liver) that would
not be affected by how the operation was performed, 12% of patients had the cancer recur just
at the site of where the operation had been; this is known as 'local' recurrence. This
suggests that a small amount of cancer was not removed at the time of surgery in these
patients. Very few studies have looked at the relationship between the Computerised
Tomography (CT) scan before surgery and the histology results (information about the tumour
after it has been examined under the microscope) and whether this can predict exactly where
the tumour recurs. If investigators can find factors that predict which patients get local
only recurrence, investigators may be able to offer improved surgical techniques or other
therapies during or immediately after the operation to these patients, hopefully leading to
improved cure rates.

This retrospective international study will look at these factors in patients who underwent a
Whipple's operation for pancreatic cancer, bile duct cancer or ampullary cancer over a three
year period between 2012 and 2015. Participating centres will provide data on pre-operative
scans, complications around the time of surgery, any therapies (e.g. chemotherapy) that the
patients had and if and where the cancer recurred. With this information, investigators hope
to find ways to predict which patients will get local-only recurrence, so researchers can
select them for future studies to see if additional treatments can improve the chance of cure
from surgery for these patients.

Broad Health ConditionPancreatic cancer
Ampullary cancer
Cholangiocarcinoma
Pancreaticoduodenectomy
Whipple's procedure
Cancer recurrence

Specific Health ConditionCancer
Pancreatic Cancer
Ampullary Cancer
Bile Duct Cancer
Cholangiocarcinoma, Extrahepatic
Cholangiocarcinoma Resectable
Cholangiocarcinoma of the Extrahepatic Bile Duct
Pancreatic Ductal Adenocarcinoma
Pancreatic Ductal Carcinoma
Surgery
Survivorship
Recurrent Cancer
Cancer Recurrent
Cancer Recurrence
Local Recurrence of Malignant Tumor of Pancreas

Recruitment statusRecruiting

Recruitment Details
Recruitment State
VIC,

Eligibility

Key inclusion criteria

Inclusion Criteria:

    -  Patients who underwent pancreaticoduodenectomy for pancreatic head malignancy.

    -  Date of surgery from 01/06/2010* to 31/05/2015 inclusive (*01/05/2006 for Plymouth
       sub-study).

    -  Post-operative surgical histology confirmed pancreatic ductal adenocarcinoma (PDAC),
       ampullary adenocarcinoma (AA) or distal bile duct cholangiocarcinoma (DBCC).

  Exclusion Criteria:

    -  Postoperative surgical histology confirmed benign pathology, non-invasive neoplasia or
       malignant tumours other than adenocarcinoma of pancreatic, ampullary or biliary
       origin.

    -  Patients who underwent distal pancreatectomy or total pancreatectomy as their primary
       procedure.

    -  Patients in whom five-year follow up data is not available.

GenderAll

Can Healthy volunteers participate?No

Contact details and further information

Sponsor Primary Sponsor Type: Other
Primary Sponsor Name: University Hospital Plymouth NHS Trust

Trial websitehttps://clinicaltrials.gov/show/NCT04596865

Trial IDNCT04596865








Study of LY3410738 Administered to Patients With Advanced Solid Tumors With IDH1 Mutations

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Trial Information

Trial summary

This is an open-label, multicenter Phase 1 study to evaluate safety, tolerability and
preliminary efficacy of oral LY3410738 in patients with IDH1 R132-mutant advanced solid tumor
types, including but not limited to cholangiocarcinoma, chondrosarcoma, and glioma.

Broad Health ConditionIDH1
CNS tumor
Cholangiocarcinoma
Chondrosarcoma
Glioma
Glioblastoma
Solid tumor
Primary CNS tumor
Colon cancer
Cancer of the Colon
Colon Neoplasms
Colonic Cancer
Neoplasms, Colonic
Malignant tumor of Breast
Mammary Cancer
Mammary Carcinoma, Human
Mammary Neoplasm, Human
Neoplasms, Breast
Tumors, Breast
Human Mammary Carcinoma
Malignant Neoplasm of Breast
Breast Carcinoma
Breast Tumors
Cancer of the Breast
Breast Neoplasms
Breast Cancer
Thyroid cancer
Prostate cancer
Melanoma
IDH1 R132

Specific Health ConditionCancer
Cholangiocarcinoma
Chondrosarcoma
Glioma
Any Solid Tumor

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW,

Hospital
St Vincent's Hospital

Phase of TrialPhase 1

Eligibility

Key inclusion criteria

Inclusion Criteria:

    1. Evidence of IDH1 R132 mutation in tumor tissue (any solid tumor) or circulating tumor
       DNA (cholangiocarcinoma, chondrosarcoma, and glioma) as determined by molecular
       testing routinely performed at a CLIA, ISO/IEC, CAP, or other similarly certified
       laboratory.

    2. Availability of an archived tumor tissue sample. Patients without an available
       archival tumor tissue sample must be discussed with the sponsor's Medical Monitor
       prior to enrollment.

    3. Eastern Cooperative Oncology Group (ECOG) 0-1

    4. At least 18 years of age

    5. Adequate organ function

    6. Ability to swallow capsules or tablets

    7. Ability to comply with outpatient treatment, laboratory monitoring, and required
       clinic visits for the duration of study participation

    8. For cholangiocarcinoma patients, must have adequate biliary drainage (per
       investigator's discretion), with no evidence of ongoing infection.

    9. Willingness of men and women of reproductive potential to observe conventional and
       effective birth control for the duration of treatment and for 3 months following the
       last dose of study treatment. Patients enrolled to Dose Expansion Cohort 4 shall also
       follow cisplatin/gemcitabine contraception duration requirements as determined by
       labels and/or local guidelines.

       Monotherapy Dose Escalation:

   10. A locally advanced or metastatic solid tumor, where standard curative or palliative
       measures are no longer effective or are not considered appropriate or safe in the
       opinion of the investigator.

   11. Measurable or non-measurable disease as determined by RECIST 1.1 or RANO as
       appropriate by tumor type.

   12. Prior IDH1 inhibitor treatment is permitted.

       Monotherapy Dose Expansion Cohort 1:

   13. Histologically or cytologically confirmed diagnosis of advanced or metastatic
       cholangiocarcinoma, following 1 to 2 lines of prior systemic treatment for advanced
       disease. Prior IDH1 inhibitor treatment is not permitted.

   14. Measurable disease as determined by RECIST 1.1.

       Monotherapy Dose Expansion Cohort 2:

   15. A locally advanced or metastatic solid tumor (except for cholangiocarcinoma), where
       standard curative or palliative measures are no longer effective or are not considered
       appropriate or safe in the opinion of the investigator.

   16. Measurable disease as determined by RECIST 1.1 or RANO as appropriate by tumor types.

       Monotherapy Dose Expansion Cohort 3:

   17. A locally advanced or metastatic solid tumor, where standard curative or palliative
       measures are no longer effective or are not considered appropriate or safe in the
       opinion of the investigator.

   18. Non-measurable disease only as determined by RECIST 1.1 or RANO as appropriate by
       tumor type.

       Combination Dose Expansion Cohort 4:

   19. Histologically or cytologically confirmed diagnosis of advanced or metastatic
       cholangiocarcinoma, not eligible for curative resection.

   20. No prior systemic therapy for advanced or metastatic disease with the following
       exceptions:

         -  Patients who received adjuvant chemotherapy are eligible, if the adjuvant therapy
            was completed at least 6 months prior to the development of advanced or
            metastatic disease.

         -  Patients who are receiving the first cycle of cisplatin plus gemcitabine as the
            first line systemic therapy while waiting for results of locally obtained
            molecule profiling including IDH1 mutational status, are eligible, provided that
            a radiographic assessment during screening demonstrates the absence of interval
            disease progression since initiation of chemotherapy treatment, and all other
            eligibility criteria are met.

   21. Measurable disease as determined by RECIST 1.1.

  Exclusion Criteria:

    1. Had an investigational agent or anticancer therapy within 2 weeks; or investigational
       monoclonal antibody within 4 weeks prior to planned start of LY3410738.

    2. Had major surgery within 4 weeks prior to planned start of LY3410738.

    3. Had radiotherapy with a limited field of radiation for palliation within 7 days of the
       first dose of study treatment, except for patients receiving whole brain radiotherapy,
       which must be completed at least 4 weeks prior to the first dose of study treatment.

    4. Patients with cholangiocarcinoma: underwent hepatic radiation, chemoembolization and
       radiofrequency ablation, radioembolization or other locoregional therapy <4 weeks,
       have history of hepatic encephalopathy of any grade, have ascites requiring
       intervention such as diuretics or paracentesis, have ongoing cholangitis, have mixed
       hepatocellular biliary tract cancer histology

    5. Have active CNS metastases are not eligible. Patients with asymptomatic and treated
       brain metastases may participate provided that they are stable and are not requiring
       steroid treatment. Patients with suspected or confirmed leptomeningeal disease are not
       eligible even if treated.

    6. Have primary CNS tumors are eligible provided that they do not have leptomeningeal
       disease and are on a stable or decreasing steroid dose for 7 days prior to screening.
       Patients with evidence of intracranial hemorrhage either by MRI or CT are not eligible

    7. Any unresolved toxicities from prior therapy greater than CTCAE (version 5.0) Grade 2
       at the time of starting study treatment except for alopecia.

    8. Have clinically significant, uncontrolled cardiac, cardiovascular disease or history
       of myocardial infarction within 6 months prior to planned start of study treatment.

    9. Have active uncontrolled systemic bacterial, viral, fungal or parasitic infection
       (except for fungal nail infection), or other clinically significant active disease
       process which in the opinion of the investigator and the sponsor makes it undesirable
       for the patient to participate in the trial. Screening for chronic conditions is not
       required.

   10. Known active hepatitis B virus (HBV). Note: Controlled (treated) hepatitis will be
       allowed if they meet the following criteria, antiviral therapy for HBV must be given
       for at least 1 month prior to first dose of study drug, and HBV viral load must be
       less than 2000 IU/ml (104 copies/ml) prior to the first dose of study drug. Those on
       active HBV therapy with viral loads under 2000 IU/ml (104 copies/ml) should stay on
       the same therapy throughout the study treatment (Appendix E).

   11. Known active hepatitis C virus (HCV). Note: Untreated patients with chronic infection
       by HCV are allowed on study. In addition, successfully treated patients (defined as
       sustained virologic response SVR12 or SVR24) are allowed, as long as there is 4 weeks
       between achieving sustained viral response (SVR12 or SVR24) and starting study drug.

   12. Known human immunodeficiency virus (HIV); excluded due to potential drug-drug
       interactions between anti-retroviral medications and LY3410738.

   13. Current treatment with certain strong cytochrome P450 3A4 (CYP3A4) inhibitors or
       inducers (Appendix F) and/or P-gp inhibitors (Appendix G).

   14. Treatment with proton pump inhibitor (PPIs) within 7 days of starting LY3410738
       (Appendix H). For recommended alternatives, refer to Section 6.4.3.

   15. Clinically significant active malabsorption syndrome or other condition likely to
       affect gastrointestinal absorption of the study drug.

   16. Active second malignancy unless in remission and with life expectancy > 2 years. Refer
       to protocol exclusion criteria (Section 4.2) for examples of allowed second
       malignancies.

   17. Pregnancy, lactation or plans to breastfeed during the study or within 3 months of the
       last dose of study intervention.

   18. Patients with known hypersensitivity to any component of LY3410738 or its formulation.

Minimum age18 Years

GenderAll

Can Healthy volunteers participate?No

Contact details and further information

Sponsor Primary Sponsor Type: Commercial sector/Industry
Primary Sponsor Name: Eli Lilly and Company

Trial websitehttps://clinicaltrials.gov/show/NCT04521686

Trial IDNCT04521686








Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of QBS10072S

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Trial Information

Trial summary

This is a multi-center, open-label, dose escalation study to determine the safety,
tolerability, pharmacokinetics, pharmacodynamics, and maximum tolerated dose (MTD) of
QBS10072S in patients with advanced or metastatic cancers with high LAT1 expression. The MTD
of QBS10072S will be confirmed in patients with relapsed or refractory grade 4 astrocytoma.

Broad Health ConditionPhase 1
Dose escalation
Metastatic
Brain metastasis
Brain metastases
GBM
Astrocytoma
Brain tumor
Cancer
Oncology
Glioblastoma
Glioblastoma multiforme
Brain
Neurology
Neuroscience
Headaches
Vomiting
Seizures
Drowsiness
Chemotherapy
Surgery
Radiation
Neuro-oncology
Blurred vision
Loss of appetite
Speech difficulty
Changes in ability to think and learn
Changes in mood and personality
Persistent headaches
Neuropathologist
Magnetic resonance spectroscopy (MRS)
Positron emission tomography (PET scan)
Intraoperative MRI
Tumor removal
Craniotomy
Standard external beam radiation therapy
Radiosurgery
Temozolomide
Bevacizumab
Avastin
Neurological exam
TMZ

Specific Health ConditionCancer
Astrocytoma
Brain Cancer
Brain Metastases
Bladder Cancer
Breast Cancer
Cervical Cancer
Cholangiocarcinoma
Colorectal Cancer
Esophagus Cancer
Gastric Cancer
Head and Neck Cancer
Kidney Cancer
Liver Cancer
Lung Cancer
Melanoma
Ovarian Cancer
Pancreatic Cancer
Pleural Mesothelioma
Prostate Cancer
Sarcoma
Tongue Cancer
Thymic Carcinoma
Urinary Tract Cancer

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW,

Hospital
St George Private Hospital

Hospital
Sydney Southwest Private Hospital

Phase of TrialPhase 1

Eligibility

Key inclusion criteria

Inclusion Criteria:

    1. Male or female participants aged =18 years at the time of informed consent.

    2. Adequate Bone Marrow Function

    3. Adequate renal function

    4. Adequate Liver Function

    5. Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade =1
       except for AEs not constituting a safety risk by Investigator judgment.

    6. A histological or cytological diagnosis of a solid tumor that is advanced/metastatic,
       patients intolerant to standard treatment or, resistant to standard therapy* (per NCCN
       guidelines) or for which no curative therapy is available for the following tumor
       types:

       - Bladder, Brain, Breast, Cervical, Cholangiocarcinoma, Colorectal, Esophageal,
       Gastric, Head and Neck, Kidney, Liver, Lung, Melanoma, Ovarian, Pancreatic, Pleural
       mesothelioma, Prostate, Sarcoma, Tongue cancer, Thymic carcinomas, Urinary tract

    7. At least one measurable lesion (as defined by RECIST version 1.1) that has not been
       previously irradiated.

    8. An ECOG PS 0 to 2.

  Exclusion Criteria:

    1. Patients with tumor primarily localized to the brainstem or spinal cord. Presence of
       known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or
       leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and/or
       progressive growth.

    2. Patients with advanced/metastatic, symptomatic, visceral spread, that are at risk of
       life-threatening complications in the short term (including patients with massive
       uncontrolled effusions [pleural, pericardial, peritoneal], pulmonary lymphangitis, and
       over 50% liver involvement).

    3. Patients with any other active malignancy within 3 years prior to enrollment, except
       for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.

    4. Major surgery within 4 weeks prior to study entry.

    5. Radiation therapy within 4 weeks prior to receiving the first QBS10072S dose (bone
       lesions requiring radiation may be treated with limited radiation therapy during this
       period).

    6. Systemic anticancer therapy within 4 weeks prior to study entry

    7. Bleeding esophageal or gastric varices <2 months prior to the date of informed
       consent.

    8. Unmanageable ascites.

    9. Baseline 12 lead ECG that demonstrates clinically relevant abnormalities that may
       affect patient safety or interpretation of study results

   10. On therapeutic anticoagulation, except low molecular weight heparin, vitamin K
       antagonists or factor Xa inhibitors may be allowed following discussion with the
       Sponsor.

   11. Any of the following in the previous 6 months: myocardial infarction, congenital long
       QT syndrome, Torsade de Pointes, clinically significant arrhythmias (including
       sustained ventricular tachyarrhythmia and ventricular fibrillation), left anterior
       hemiblock, bifascicular block, unstable angina, coronary/peripheral artery bypass
       graft, symptomatic congestive heart failure (New York Heart Association class III or
       IV), cerebrovascular accident, transient ischemic attack, or symptomatic pulmonary
       embolism or other clinical significant episode of thromboembolic disease. Ongoing
       cardiac dysrhythmias of NCI CTCAE Grade =2, atrial fibrillation of any grade (Grade =2
       in the case of asymptomatic lone atrial fibrillation).

   12. Hypertension that cannot be controlled by medications (>150/90 mmHg despite optimal
       medical therapy) or requiring more than two medications for adequate control.

Minimum age18 Years

GenderAll

Can Healthy volunteers participate?No

Contact details and further information

Sponsor Primary Sponsor Type: Commercial sector/Industry
Primary Sponsor Name: Quadriga Biosciences, Inc.

Trial websitehttps://clinicaltrials.gov/show/NCT04430842

Trial IDNCT04430842








Comparing NUC-1031 Plus Cisplatin to Gemcitabine Plus Cisplatin in Patients With Advanced Biliary Tract Cancer

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Trial Information

Trial summary

NuTide:121 compares NUC-1031 with gemcitabine, both in combination with cisplatin, in
patients with previously untreated advanced biliary tract cancer.

The primary hypotheses are:

  -  The combination of NUC-1031 plus cisplatin prolongs overall survival compared to the
     gemcitabine plus cisplatin standard of care

  -  The combination of NUC-1031 plus cisplatin increases overall response rate compared to
     the gemcitabine plus cisplatin standard of care

Broad Health ConditionAdenocarcinoma
Ampullary
Antineoplastic Agents
Biliary Tract Cancer
Chemotherapy
Cholangiocarcinoma
Cisplatin
Digestive System Neoplasms
Distal Bile Duct
Extrahepatic
First-line Chemotherapy
Gallbladder
Gastrointestinal
Gemcitabine
Hepatobiliary
Intrahepatic
Locally advanced
Metastatic
Neoplasm
NUC-1031
ProTides
Untreated

Specific Health ConditionCancer
Biliary Tract Cancer

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW,QLD,VIC,WA,

Hospital
St George Hospital

Hospital
Newcastle Private Hospital

Hospital
Westmead Hospital

Hospital
The Alfred Hospital

Hospital
Fiona Stanley Hospital

Hospital
Sir Charles Gairdner Hospital

Phase of TrialPhase 3

Eligibility

Key inclusion criteria

Inclusion Criteria:

    1. Written informed consent and authorization to use and disclose health information.

    2. Ability to comprehend and willingness to comply with the requirements of this
       protocol, including the QoL questionnaires.

    3. Female or male patients aged =18 years.

    4. Histologically- or cytologically-confirmed adenocarcinoma of the biliary tract
       (including gallbladder, intra and extra-hepatic biliary ducts and ampullary cancers)
       that is locally advanced, unresectable or metastatic (AJCC edition 8, 2018). Patients
       with measurable (as per RECIST v1.1 criteria) or non-measurable disease are permitted.

    5. Life expectancy =16 weeks.

    6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.

    7. Adequate biliary drainage with no evidence of ongoing infection. If applicable,
       treatable and clinically-relevant biliary duct obstruction has been relieved by
       internal endoscopic drainage/stenting at least 2 weeks previously or by palliative
       bypass surgery or percutaneous drainage prior to study treatment, and the patient has
       no active or suspected uncontrolled infection. Patients fitted with a biliary stent
       should be clinically stable and free of signs of infection for =2 weeks prior to study
       treatment. Patients with improving biliary function who meet all other inclusion
       criteria may be re-tested during the screening window.

    8. Adequate bone marrow, hepatic, and renal function, as evidenced by:

         -  Absolute neutrophil count (ANC) =1,500/µL without colony-stimulating factor
            support

         -  Platelet count =100,000/µL

         -  Haemoglobin =9 g/dL without need for haematopoietic growth factor or transfusion
            support in prior 2 weeks

         -  Total bilirubin <2 × upper limit of normal (ULN); does not apply to patients with
            Gilbert's syndrome. Consistent with inclusion criterion 7, patients whose whole
            bilirubin and biliary function is recovering may be re-tested during the
            screening period.

         -  Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) <5 × ULN

         -  Creatinine clearance =45 mL/min actual or calculated by the Cockcroft-Gault
            method

         -  International normalized ratio (INR) <1.5 and activated partial thromboplastin
            time (aPTT) <1.5 × ULN; does not apply to patients on an anti-coagulant with
            stable dose 28 days prior to first dose.

    9. QTc interval <450 msec (males) or <470 msec (females), in the absence of bundle branch
       block. In the presence of bundle branch block with consequent QTc prolongation,
       patients may be enrolled based on a careful risk-benefit assessment.

   10. Human Immunodeficiency Virus-infected patients who are healthy and have a low risk of
       Acquired Immunodeficiency Syndrome-related outcomes may be included in this study.

   11. Female patients of child-bearing potential (i.e., all women except those who are
       post-menopausal for =1 year or who have a history of hysterectomy or surgical
       sterilization) must have a negative pregnancy test within 3 days prior to the first
       study drug administration. All patients of child-bearing potential must agree to
       practice true abstinence or to use two highly effective forms of contraception, one of
       which must be a barrier method of contraception, from the time of screening until 6
       months after the last dose of study medication.

   12. Male patients with a female partner must either have had a successful vasectomy or
       they and their female partner meet the criteria above (not of childbearing potential
       or practicing highly effective contraceptive methods).

  Exclusion Criteria:

    1. Combined or mixed hepatocellular/cholangiocarcinoma.

    2. Prior systemic therapy for advanced or metastatic biliary tract cancer. However, prior
       chemotherapy in the adjuvant setting or low-dose chemotherapy given in conjunction
       with radiotherapy in the adjuvant setting and completed at least 6 months prior to
       enrolment is permitted. The following prior interventions are allowed provided the
       patient has fully recovered:

         -  Surgery: non-curative resection with macroscopic residual disease or palliative
            bypass surgery. Patients who have previously undergone curative surgery must now
            have evidence of non-resectable disease requiring systemic chemotherapy.

         -  Radiotherapy: prior radiotherapy (with or without radio-sensitizing low-dose
            chemotherapy) for localized disease and there is now clear evidence of disease
            progression requiring systemic chemotherapy.

         -  Photodynamic therapy: prior photodynamic therapy for localized disease with no
            evidence of metastatic disease or for localized disease to relieve biliary
            obstruction in the presence of metastatic disease provided there is now clear
            evidence of disease progression requiring systemic chemotherapy.

         -  Palliative radiotherapy: palliative radiotherapy provided that all adverse events
            have resolved and the patient has measurable disease outside the field of
            radiation.

    3. Prior treatment with or known hypersensitivity to NUC-1031, gemcitabine, cisplatin or
       other platinum-based agents or history of allergic reactions attributed to any
       parenteral excipients (e.g. dimethylacetamide [DMA], Cremophor EL, Polysorbate 80,
       Solutol HS 15).

    4. Symptomatic central nervous system or leptomeningeal metastases.

    5. History of other malignancies, except adequately treated non-melanoma skin cancer,
       curatively treated in situ cancer of the cervix, surgically excised or potentially
       curatively treated ductal carcinoma in situ of the breast, or low grade prostate
       cancer or patients after prostatectomy not requiring treatment. Patients with previous
       invasive cancers are eligible if treatment was completed more than 3 years prior to
       initiating the current study treatment, and the patient has had no evidence of
       recurrence since then.

    6. Concurrent serious (as deemed by the Investigator) medical conditions, including, but
       not limited to, New York Heart Association class III or IV congestive heart failure,
       history of congenital prolonged QT syndrome, uncontrolled infection, active hepatitis
       B or C, or other co-morbid conditions that in the opinion of the Investigator would
       impair study participation or cooperation.

    7. Congenital or acquired immunodeficiency (e.g., serious active infection with HIV). As
       per inclusion criterion 10, patients with HIV who are healthy and have a low risk of
       AIDS related outcomes are eligible.

    8. Other acute or chronic medical, neurological, or psychiatric condition or laboratory
       abnormality that may increase the risk associated with study participation or
       investigational product administration or may interfere with the interpretation of
       study results and, in the judgment of the Investigator, would make the patient
       inappropriate for entry into this study.

    9. Prior exposure to another investigational agent within 28 days prior to randomization.

   10. Major surgery within 28 days prior to randomization; patient must have completely
       recovered from any prior surgical or other procedures.

   11. Pregnant or breastfeeding.

   12. Residual toxicities from prior treatments or procedures which have not regressed to
       Grade =1 severity (CTCAE v5.0), except for alopecia or = Grade 2 peripheral
       neuropathy.

   13. Concomitant use of drugs at doses known to cause clinically relevant prolongation of
       QT/QTc interval.

   14. Administration of a live vaccination within 28 days prior to randomization.

   15. Ongoing or recent (=6 months) hepatorenal syndrome.

Minimum age18 Years

GenderAll

Can Healthy volunteers participate?No

Contact details and further information

Sponsor Primary Sponsor Type: Other
Primary Sponsor Name: NuCana plc

Trial websitehttps://clinicaltrials.gov/show/NCT04163900

Trial IDNCT04163900








Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) in Previously Treated Participants With Select Solid Tumors (MK-7902-005/E7080-G000-224/LEAP-005)

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Trial Information

Trial summary

The purpose of this study is to determine the safety and efficacy of combination therapy with
pembrolizumab (MK-3475) and lenvatinib (E7080/MK-7902) in participants with triple negative
breast cancer (TNBC), ovarian cancer, gastric cancer, colorectal cancer (CRC), glioblastoma
(GBM), biliary tract cancers (BTC), or pancreatic cancer.

Broad Health Conditionprogrammed cell death 1 (PD-1, PD1)
programmed cell death ligand 1 (PD-L1, PDL1)
programmed cell death ligand 2 (PD-L2, PDL2)
tyrosine kinase inhibitor (TKI)
multiple TKI
Vascular Endothelial Growth Factor Receptor (VEFG)
Fibroblast Growth Factor (FGF)
Platelet-Derived Growth Factor (PDGF)

Specific Health ConditionCancer
Advanced Solid Tumors
Triple Negative Breast Cancer
Ovarian Cancer
Gastric Cancer
Colorectal Cancer
Glioblastoma
Biliary Tract Cancers
Pancreatic Cancer

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
QLD,VIC,WA,

Hospital
Royal Brisbane and Women s Hospital ( Site 0901)

Hospital
Sir Charles Gairdner Hospital ( Site 0903)

Phase of TrialPhase 2

Eligibility

Key inclusion criteria

Inclusion Criteria:

    -  Has a histologically or cytologically-documented, advanced (metastatic and/or
       unresectable) solid tumor that is incurable and for which prior standard systemic
       therapy has failed in one of the following cohorts: TNBC, Ovarian Cancer, Gastric
       Cancer, Colorectal Cancer, GBM, BTC (intrahepatic, extrahepatic cholangiocarcinoma and
       gall bladder cancer; excludes Ampulla of Vater), Pancreatic Cancer

    -  Must have progressed on or since the last treatment

    -  Has measurable disease per RECIST 1.1 (RANO for the GBM cohort) as assessed by the
       local site investigator/radiology and confirmed by BICR

    -  Has provided a PD-L1 evaluable archival tumor tissue sample or newly obtained core or
       excisional biopsy of a tumor lesion not previously irradiated

    -  Male participants agree to use approved contraception during the treatment period for
       at least 7 days after the last dose of lenvatinib, or refrain from heterosexual
       intercourse during this period

    -  Female participants are not pregnant or breastfeeding, and are not a woman of
       childbearing potential (WOCBP), OR are a WOCBP that agrees to use contraception during
       the treatment period (or 14 days prior to the initiation of study treatment for oral
       contraception) and for at least 120 days post pembrolizumab, or 30 days post
       lenvatinib, whichever occurs last

    -  Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 3
       days of study treatment initiation

    -  Has adequate organ function

  For Triple Negative Breast Cancer Participants:

    -  Has received one or 2 prior lines of therapy

    -  Has Lactate Dehydrogenase (LDH) <2.0 x Upper Limit of Normal (ULN)

    -  Has locally determined results for estrogen receptor, progesterone receptor, and human
       epidermal growth factor receptor 2 tumor analyses

  For Ovarian Cancer Participants:

  - Has primary ovarian cancer and has received 3 prior lines of therapy.

  For Gastric Cancer Participants:

  - Has received 2 prior lines of therapy. Note: Gastric cancer will include participants
  with both gastric and gastroesophageal junction (GEJ) adenocarcinoma. Participants with
  squamous cell carcinoma histology are not eligible

  For Colorectal Cancer Participants:

  - Has received 2 prior lines of therapy

  For GBM Participants:

    -  Has failed initial systemic therapy for newly diagnosed GBM

    -  Have the following time periods elapsed before the projected start of scheduled study
       treatment: 1) at least 3 weeks from prior surgical resection, 2) at least 1 week from
       stereotactic biopsy, 3) at least 6 months from completion of prior radiotherapy, 4) at
       least 4 weeks (or 5 half-lives, whichever is shorter) from any investigational agent,
       5) at least 4 weeks from cytotoxic therapy, 6) at least 6 weeks from antibodies, 7) at
       least 4 weeks (or 5 half-lives, whichever is shorter) from other antitumor therapies
       and 1 week for cancer vaccines

    -  Be neurologically stable (e.g. without a progression of neurologic symptoms or
       requiring escalating doses of systemic steroid therapy within last 2 weeks) and
       clinically stable

    -  Has histologically confirmed World Health Organization (WHO) Grade IV GBM

    -  Has locally determined result for O^6-methylguanine-DNA methyltransferase (MGMT)
       analysis

  For Biliary Tract Cancer Participants:

    -  Has received 1 prior line of therapy

    -  Child-Pugh Score, Class A: well-compensated disease. Child-Pugh Score of 5-6

  For Pancreatic Cancer Participants:

    -  Has pathologically (histologically or cytologically) confirmed pancreatic ductal
       adenocarcinoma that is metastatic at enrollment

    -  Has received one or 2 prior lines of therapy

    -  Has received prior therapy with at least 1 (platinum-containing regimen or
       gemcitabine-containing regimen) but no more than 2 prior systemic therapies for
       unresectable or metastatic pancreatic cancer

  Exclusion Criteria:

    -  Has gastrointestinal malabsorption or any other condition that might affect the
       absorption of lenvatinib

    -  Has present or progressive accumulation of pleural, ascitic, or pericardial fluid
       requiring drainage or diuretic drugs within 2 weeks prior to enrollment (applies to
       all cohorts except the ovarian cancer cohort)

    -  Has radiographic evidence of encasement or invasion of a major blood vessel or of
       intratumoral cavitation. Participants with portal vein invasion (Vp4), inferior vena
       cava, or cardiac involvement based on imaging in the BTC cohort are not eligible for
       enrollment

    -  Has clinical significant hemoptysis or tumor bleeding within 2 weeks prior to the
       first dose of study treatment

    -  Has significant cardiovascular impairment within 12 months of the first dose of study
       treatment, such as history of congestive heart failure greater than New York Heart
       Association (NYHA) Class II, unstable angina, myocardial infarction or cerebrovascular
       accident (CVA), or cardiac arrhythmia associated with hemodynamic instability

    -  Has a history of arterial thromboembolism within 12 months of start of study treatment

    -  Has a known additional malignancy that is progressing or has required active treatment
       within the past 3 years.

    -  Has a serious nonhealing wound, ulcer or bone fracture

    -  Has had major surgery within 3 weeks prior to first dose of study interventions

    -  Has biologic response modifiers therapy (e.g. granulocyte colony-stimulating factor)
       within 4 weeks before study entry

    -  Has preexisting =Grade 3 gastrointestinal (GI) or non-gastrointestinal fistula

    -  Has received prior therapy with lenvatinib, an anti-PD-1, anti-PD-L1, or anti PD-L2
       agent or with an agent directed to another stimulatory or co-inhibitory T-cell
       receptor (e.g. cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], Tumor necrosis
       factor receptor superfamily, member 4 [OX 40], tumor necrosis factor receptor
       superfamily member 9 [CD137])

    -  Has received prior systemic anti-cancer therapy including investigational agents
       within 4 weeks prior to study treatment start

    -  If participant received major surgery, they must have recovered adequately from the
       toxicity and/or complications from the intervention prior to starting study treatment

    -  Has received prior radiotherapy within 2 weeks of start of study treatment.
       Participants must have recovered from all radiation-related toxicities, not require
       corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted
       for palliative radiation (=2 weeks of radiotherapy) to non-central nervous system
       (CNS) disease

    -  Has received a live vaccine within 30 days prior to the first dose of study treatment

    -  Has known intolerance to lenvatinib (and/or any of the excipients)

    -  Is currently participating in or has participated in a study of an investigational
       agent or has used an investigational device within 4 weeks prior to the first dose of
       study treatment

    -  Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
       (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of
       immunosuppressive therapy within 7 days prior the first dose of study treatment

    -  Has known active CNS metastases and/or carcinomatous meningitis

    -  Has tumors involving the brain stem

    -  Has severe hypersensitivity (=Grade 3) to pembrolizumab and/or any of its excipients

    -  Has an active autoimmune disease that has required systemic treatment in past 2 years

    -  Has a history of (non-infectious) pneumonitis that required steroids or has current
       pneumonitis

    -  Has an active infection requiring systemic therapy

    -  Has a known history of human immunodeficiency virus (HIV) infection

    -  Has a known history of hepatitis B or known active hepatitis C virus infection

    -  Has a known history of active tuberculosis (TB; Bacillus tuberculosis)

    -  Is pregnant or breastfeeding or expecting to conceive or father children within the
       projected duration of the study, starting with the screening visit through 120 days
       after the last dose of study treatment

    -  Has had an allogenic tissue/solid organ transplant (large organ transplants, stem-cell
       transplant requiring chronic immunosuppressant therapy necessary to prevent graft
       rejection)

  For GBM Participants:

    -  Has carcinomatous meningitis

    -  Has recurrent tumor greater than 6 cm in maximum diameter

    -  Has tumor primarily localized to the brainstem or spinal cord

    -  Has presence of multifocal tumor, diffuse leptomeningeal or extracranial disease

    -  Has evidence of intratumoral or peritumoral hemorrhage on baseline magnetic resonance
       imaging (MRI) scan other than those that are grade = 1 and either post-operative or
       stable on at least 2 consecutive MRI scans

    -  Has received Optune® TTFields within 2 weeks of study intervention

Minimum age18 Years

GenderAll

Can Healthy volunteers participate?No

Contact details and further information

Sponsor Primary Sponsor Type: Commercial sector/Industry
Primary Sponsor Name: Merck Sharp & Dohme Corp.

Trial websitehttps://clinicaltrials.gov/show/NCT03797326

Trial IDNCT03797326








Phase 3 Study of BGJ398 (Oral Infigratinib) in First Line Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations

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Trial Information

Trial summary

Infigratinib is an oral drug which selectively binds to fibroblast growth factor receptor
(FGFR) 2 and is being developed to treat participants with FGFR2 mutated cholangiocarcinoma.
The purpose of the study is to evaluate the efficacy and safety of the investigational agent
oral infigratinib vs standard of care chemotherapy (gemcitabine plus cisplatin) in first-line
treatment of participants with unresectable locally advanced or metastatic cholangiocarcinoma
with FGFR2 fusion/rearrangement. Subjects will be randomized 2:1 to receive infigratinib or
gemcitabine plus cisplatin.

Broad Health Conditioncholangiocarcinoma
unresectable cholangiocarcinoma
metastatic cholangiocarcinoma
fibroblast growth factor receptor inhibitor
FGFR2
FGFR2 gene fusions/translocations
BGJ398

Specific Health ConditionCancer
Advanced Cholangiocarcinoma
FGFR2 Gene Mutation

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW,SA,VIC,WA,

Hospital
Chris O'Brien Lifehouse Hospital

Hospital
Blacktown Hospital

Hospital
Royal Adelaide Hospital

Hospital
St John of God Hospital Subiaco

Phase of TrialPhase 3

Eligibility

Key inclusion criteria

Inclusion Criteria:

    -  Histologically or cytologically confirmed unresectable locally advanced or metastatic
       cholangiocarcinoma. Participants with gallbladder cancer or ampulla of Vater carcinoma
       are not eligible

    -  Have written documentation of local laboratory or central laboratory determination of
       a known or likely activating FGFR2 fusion/rearrangement from a sample collected before
       randomization

    -  Have an archival tumor tissue sample available with sufficient tumor content for FGFR2
       fusion/rearrangement molecular testing by the central laboratory. However, if an
       archival tumor tissue sample is not available, or does not meet requirements for
       central testing a newly obtained (before randomization) tumor biopsy may be submitted
       instead. If a prestudy written documentation of FGFR2 fusion/rearrangement in tumor
       tissue is available from the central laboratory, an additional tumor sample does not
       need to be submitted.

    -  Have an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

    -  Are able to swallow and retain oral medication

    -  Are willingness to avoid pregnancy or father children

  Exclusion Criteria:

    -  Received treatment with any systemic anti-cancer therapy for unresectable locally
       advanced or metastatic cholangiocarcinoma, with following exceptions

         1. Prior neoadjuvant or adjuvant therapy is permitted if completed > 6 months after
            the last dose of neoadjuvant or adjuvant therapy.

         2. One cycle of gemcitabine-based chemotherapy for locally advanced or metastatic
            cholangiocarcinoma is permitted before randomization

    -  History of a liver transplant

    -  Received previously or currently is receiving treatment with a mitogen activated
       protein kinase kinase (MEK) or selective FGFR inhibitor

    -  Have impairment of gastrointestinal (GI) function or GI disease that may significantly
       alter the absorption of oral infigratinib (such as, ulcerative diseases, uncontrolled
       nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection).

    -  Current evidence of endocrine alterations of calcium/phosphate homeostasis, e.g.,
       parathyroid disorders, history of parathyroidectomy, tumor lysis, tumoral calcinosis
       etc.

    -  History and/or current evidence of extensive tissue calcification including, but not
       limited to, the soft tissue, kidneys, intestine, myocardium, vascular system and lung
       with the exception of calcified lymph nodes, minor pulmonary parenchymal
       calcifications, and asymptomatic coronary calcification

    -  Current evidence of corneal or retinal disorder/keratopathy

    -  Receiving and continued treatment or are planning to receive agents or consuming foods
       that are known moderate or strong inducers or inhibitors of CYP3A4 and medications
       which increase serum phosphorus and/or calcium concentration

    -  Clinically significant or uncontrolled cardiac disease

    -  Recent (= 3 months prior to first dose of study drug) transient ischemic attack or
       stroke

    -  Severe hearing loss

    -  Severe neuropathy

    -  History of another primary malignancy within 3 years except adequately treated in-situ
       carcinoma of the cervix or non-melanoma skin cancer or other curatively treated
       malignancy that is not expected to require treatment

    -  Pregnant or breastfeeding

    -  Have known microsatellite instability-high (MSI-H) disease and the decision is made by
       the treating investigator that an alternative, non-study therapy is warranted
       according to standard of care.

    -  Have any known hypersensitivity to gemcitabine, cisplatin, calcium-lowering agents,
       infigratinib, or their excipients

    -  Have any contraindication to cisplatin or gemcitabine treatment according to local
       labeling or standard institutional practice.

    -  Have taken any Chinese herbal medicine or Chinese patent medicine treatments with
       anticancer activity within 14 days of the first dose of study drug.

    -  Have received a live vaccine within 30 days before the first dose of study drug or are
       planning to receive a live vaccine during participation in this study

Minimum age18 Years

GenderAll

Can Healthy volunteers participate?No

Contact details and further information

Sponsor Primary Sponsor Type: Commercial sector/Industry
Primary Sponsor Name: QED Therapeutics, Inc.

Trial websitehttps://clinicaltrials.gov/show/NCT03773302

Trial IDNCT03773302








Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-158/KEYNOTE-158)

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Trial Information

Trial summary

In this study, participants with multiple types of advanced (unresectable and/or metastatic)
solid tumors who have progressed on standard of care therapy will be treated with
pembrolizumab (MK-3475).

Broad Health ConditionProgrammed Cell Death-1 (PD1, PD-1)
Programmed Death-Ligand 1 (PDL1, PD-L1)
microsatellite instability (MSI)
mismatch repair (MMR)

Specific Health ConditionCancer
Advanced Cancer
Anal Carcinoma
Anal Cancer
Biliary Cancer
Cholangiocarcinoma
Bile Duct Cancer
Neuroendocrine Tumor
Carcinoid Tumor
Endometrial Carcinoma
Endometrial Cancer
Cervical Carcinoma
Cervical Cancer
Vulvar Carcinoma
Vulvar Cancer
Small Cell Lung Carcinoma
Small Cell Lung Cancer (SCLC)
Mesothelioma
Thyroid Carcinoma
Thyroid Cancer
Salivary Gland Carcinoma
Salivary Gland Cancer
Salivary Cancer
Parotid Gland Cancer
Advanced Solid Tumors
Colorectal Carcinoma

Trial FocusTreatment

Recruitment statusRecruiting

Phase of TrialPhase 2

Eligibility

Key inclusion criteria

Inclusion Criteria:

  - Histologically or cytologically-documented, advanced solid tumor of one of the following
  types:

    -  Anal Squamous Cell Carcinoma

    -  Biliary Adenocarcinoma (gallbladder or biliary tree (intrahepatic or extrahepatic
       cholangiocarcinoma) except Ampulla of Vater cancers)

    -  Neuroendocrine Tumors (well- and moderately-differentiated) of the lung, appendix,
       small intestine, colon, rectum, or pancreas

    -  Endometrial Carcinoma (sarcomas and mesenchymal tumors are excluded)

    -  Cervical Squamous Cell Carcinoma

    -  Vulvar Squamous Cell Carcinoma

    -  Small Cell Lung Carcinoma

    -  Mesothelioma

    -  Thyroid Carcinoma

    -  Salivary Gland Carcinoma (sarcomas and mesenchymal tumors are excluded)

    -  Any advanced solid tumor, with the exception of colorectal carcinoma (CRC), which is
       Microsatellite Instability (MSI)-High (MSI-H) OR

    -  Any advanced solid tumor (including Colorectal Carcinoma [CRC]) which is Mismatch
       Repair Deficient (dMMR)/MSI-H in participants from mainland China who are of Chinese
       descent. (CRC participants will have a histologically proven locally advanced
       unresectable or metastatic CRC which is dMMR/MSI-H that has received 2 prior lines of
       therapy.) OR

    -  Any advanced solid tumor that has failed at least one line of therapy and is TMB-H
       (=10 mut/Mb, F1CDx assay), excluding dMMR/MSI-H tumors.

  Note: For participants to be eligible for enrollment they must have failed at least one
  line of standard of care systemic therapy (ie, not treatment naïve), with the exception of
  CRC participants who must have failed at least 2 lines of standard of care systemic
  therapy, as per CRC specific eligibility criteria. Participants must not have melanoma or
  NSCLC.

    -  Progression of tumor or intolerance to therapies known to provide clinical benefit.
       There is no limit to the number of prior treatment regimens

    -  Can supply tumor tissue for study analyses (dependent on tumor type)

    -  Radiologically-measurable disease

    -  Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG)
       Performance Scale within 3 days prior to first dose of pembrolizumab

    -  Life expectancy of at least 3 months

    -  Adequate organ function

    -  Female participants of childbearing potential must be willing to use adequate
       contraception during the intervention period and for at least the time needed to
       eliminate each study intervention after the last dose of study intervention. and
       agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for
       the purpose of reproduction during this period. The length of time required to
       continue contraception for each study intervention is as follows: MK-3475 (120 days)

  Exclusion Criteria:

    -  Currently participating and receiving study therapy or has participated in a study of
       an investigational agent and received study therapy or used an investigational device
       within 4 weeks of the first dose of study treatment

    -  Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form
       of immunosuppressive therapy within 7 days prior to the first dose of study treatment

    -  Active autoimmune disease that has required systemic treatment in the past 2 years

    -  Prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or not
       recovered from an adverse event caused by mAbs administered more than 4 weeks earlier

    -  Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2
       weeks of study Day 1 or not recovered from adverse events caused by a previously
       administered agent

    -  Known additional malignancy within 2 years prior to enrollment with the exception of
       curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the
       skin and/or curatively resected in situ cancers

    -  Known active central nervous system (CNS) metastases and/or carcinomatous meningitis

    -  Has known glioblastoma multiforme of the brain stem

    -  Has a history of (noninfectious) pneumonitis/interstitial lung disease that required
       steroids or current pneumonitis/interstitial lung disease.

    -  Active infection requiring systemic therapy

    -  Known psychiatric or substance abuse disorders that would interfere with the
       participant's ability to cooperate with the requirements of the study

    -  Pregnant, breastfeeding, or expecting to conceive or father children within the
       projected duration of the study, starting with the screening visit through 120 days
       after the last dose of study treatment

    -  Previously participated in any other pembrolizumab (MK-3475) study, or received prior
       therapy with an anti-programmed cell death (PD)-1, anti-PD-Ligand 1 (anti-PD-L1),
       anti-PD-Ligand 2 (anti-PD-L2), or any other immunomodulating mAb or drug specifically
       targeting T-cell co-stimulation or checkpoint pathways

    -  Known history of Human Immunodeficiency Virus (HIV)

    -  Known active Hepatitis B or C

    -  Received live vaccine within 30 days of planned start of study treatment

    -  Has severe hypersensitivity (=Grade 3) to pembrolizumab and/or any of its excipients

    -  Known history of active tuberculosis (TB, Bacillus tuberculosis)

    -  Has had an allogenic tissue/solid organ transplant.

Minimum age18 Years

GenderAll

Can Healthy volunteers participate?No

Contact details and further information

Sponsor Primary Sponsor Type: Commercial sector/Industry
Primary Sponsor Name: Merck Sharp & Dohme Corp.

Trial websitehttps://clinicaltrials.gov/show/NCT02628067

Trial IDNCT02628067








Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK Gene Rearrangements (Fusions)

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Trial Information

Trial summary

This is an open-label, multicenter, global Phase 2 basket study of entrectinib (RXDX-101) for
the treatment of patients with solid tumors that harbor an NTRK1/2/3, ROS1, or ALK gene
fusion. Patients will be assigned to different baskets according to tumor type and gene
fusion.

Broad Health ConditionEntrectinib
RXDX-101
TrkA
TrkB
TrkC
NTRK1
NTRK2
NTRK3
ROS1
ALK
Trk Fusions
NTRK Gene Rearrangements
ROS1 Fusions
ROS1 Gene Rearrangements
ALK Fusions
ALK Gene Rearrangements
Basket study
Non-small cell lung cancer
Colorectal cancer
Salivary gland cancers
Primary brain tumors
Melanoma
Sarcomas
Papillary thyroid cancer
Renal cell cancer
Pancreatic cancer
Breast cancer
Cholangiocarcinoma
Head & Neck cancers
Ovarian cancer
Neuroendocrine tumors

Specific Health ConditionCancer
Breast Cancer
Cholangiocarcinoma
Colorectal Cancer
Head and Neck Neoplasms
Lymphoma, Large-Cell, Anaplastic
Melanoma
Neuroendocrine Tumors
Non-Small Cell Lung Cancer
Ovarian Cancer
Pancreatic Cancer
Papillary Thyroid Cancer
Primary Brain Tumors
Renal Cell Carcinoma
Sarcomas
Salivary Gland Cancers
Adult Solid Tumor

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW,SA,VIC,

Hospital
Liverpool Hospital

Hospital
Newcastle Private Hospital

Hospital
Austin Hospital

Phase of TrialPhase 2

Eligibility

Key inclusion criteria

Inclusion Criteria:

    -  Histologically- or cytologically-confirmed diagnosis of locally advanced or metastatic
       solid tumor that harbors an NTRK1/2/3, ROS1, or ALK gene rearrangement

    -  For patients enrolled via local molecular testing, an archival or fresh tumor tissue
       (unless medically contraindicated) is required to be submitted for independent central
       molecular testing at Ignyta's CLIA laboratory post-enrollment

    -  Measurable or evaluable disease

    -  Patients with CNS involvement, including leptomeningeal carcinomatosis, which is
       either asymptomatic or previously-treated and controlled, are allowed

    -  Prior anticancer therapy is allowed (excluding approved or investigational Trk, ROS1,
       or ALK inhibitors in patients who have tumors that harbor those respective gene
       rearrangements)

       - Note: prior treatment with crizotinib is permitted only in ALK- or ROS1-rearranged
       NSCLC patients presenting with CNS-only progression. Other ALK inhibitors are
       prohibited.

    -  At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed after prior
       chemotherapy or small molecule targeted therapy

    -  At least 4 weeks must have elapsed since completion of antibody-directed therapy

    -  Prior radiotherapy is allowed if more than 14 days have elapsed since the end of
       treatment

    -  Eastern Cooperative Oncology Group (ECOG) performance status = 2 and minimum life
       expectancy of 4 weeks

    -  Adequate organ function as defined per protocol

    -  Ability to swallow entrectinib intact

    -  Other protocol specified criteria

  Exclusion Criteria:

    -  Current participation in another therapeutic clinical trial

    -  Prior treatment with approved or investigational Trk, ROS1, or ALK inhibitors in
       patients who have tumors that harbor those respective gene rearrangements

       - Note: prior treatment with crizotinib is permitted only in ALK- or ROS1-rearranged
       NSCLC patients presenting with CNS-only progression. Other ALK inhibitors are
       prohibited.

    -  History of other previous cancer that would interfere with the determination of safety
       or efficacy

    -  Familial or personal history of congenital bone disorders, or bone metabolism
       alterations

    -  Incomplete recovery from any surgery

    -  History of recent (within the past 3 months) symptomatic congestive heart failure or
       ejection fraction =50% observed during screening for the study

    -  History of non-pharmacologically induced prolonged QTc interval

    -  History of additional risk factors for torsades de pointes

    -  Peripheral neuropathy Grade = 2

    -  Known active infections

    -  Active gastrointestinal disease or other malabsorption syndromes

    -  Known interstitial lung disease, interstitial fibrosis, or history of tyrosine kinase
       inhibitor-induced pneumonitis

    -  Other protocol specified criteria

Minimum age18 Years

GenderAll

Can Healthy volunteers participate?No

Contact details and further information

Sponsor Primary Sponsor Type: Commercial sector/Industry
Primary Sponsor Name: Hoffmann-La Roche

Trial websitehttps://clinicaltrials.gov/show/NCT02568267

Trial IDNCT02568267








Adjuvant Chemotherapy With Gemcitabine and Cisplatin Compared to Standard of Care After Curative Intent Resection of Biliary Tract Cancer

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Trial Information

Trial summary

This is a multicenter, prospective, randomized, controlled phase III trial designed to assess
the clinical performance of gemcitabine with cisplatin and observation vs. standard of care
(observation alone in stage 1 and capecitabine and observation in stage 2) in patients after
curative intent resection of BTC including an embedded sub-study for R1 resected patients
receiving additional chemoradiation.

Broad Health Conditionadjuvant chemotherapy
cholangiocarcinoma
muscle invasive gall bladder carcinoma
translational research
multidisciplinary
AIO, DGAV, DGVS

Specific Health ConditionCancer
Cholangiocarcinoma
Gall Bladder Carcinoma

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW,QLD,SA,WA,

Hospital
Bankstown Hospital

Hospital
Nepean Hospital Cancer Care

Hospital
St. George Hospital

Hospital
Prince of Wales Hospital

Hospital
Townsville Hospital

Hospital
Royal Brisbane and Women's Hospital

Hospital
Princess Alexandra Hospital

Hospital
Fiona Stanley Hospital Perth

Hospital
Sir Charles Gairdner Hospital

Phase of TrialPhase 3

Eligibility

Key inclusion criteria

All enrolled patients will postoperatively be assessed for eligibility for the treatment
  phase. Additionally patients not previously enrolled into the trial for whatever reason
  (e.g. incidental finding during surgery) will be evaluated for eligibility.

    -  Histologically confirmed adenocarcinoma of biliary tract (intrahepatic, hilar or
       extrahepatic cholangiocarcinoma or muscle invasive gallbladder carcinoma) after
       radical surgical therapy with macroscopically complete resection (mixed tumor entities
       (HCC/CCA) are excluded)

    -  Macroscopically complete resection (R0/1) within 6 (-16) weeks before scheduled start
       of chemotherapy

    -  ECOG 0-1

    -  Age =18 years

    -  Adequate hematologic function

    -  Adequate liver function

    -  Adequate renal function

    -  No active uncontrolled infection, except chronic viral hepatitis under antiviral
       therapy

    -  No concurrent treatment with other experimental drugs or other anti-cancer therapy,
       treatment in a clinical trial within 30 days prior to randomization

    -  Negative serum pregnancy test within 7 days of starting study treatment in
       pre-menopausal women and women <1 year after the onset of menopause (Note: a negative
       test has to be reconfirmed by a urine test, should the 7-day window be exceeded)

  Criteria for initial study enrolment

    -  Written informed consent

    -  No prior chemotherapy for cholangiocarcinoma

    -  No previous malignancy within 3 years or concomitant malignancy, except:
       non-melanomatous skin cancer or adequately treated in situ cervical cancer

    -  No severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or
       IV, unstable angina pectoris, history of myocardial infarction in the last 3 months,
       significant arrhythmia)

    -  Absence of psychiatric disorder precluding understanding of information of trial
       related topics and giving informed consent

    -  No serious underlying medical conditions (judged by the investigator), that could
       impair the ability of the patient to participate in the trial

    -  Fertile women (< 1 year after last menstruation) and procreative men willing and able
       to use effective means of contraception (oral contraceptives, intrauterine
       contraceptive device, barrier method of contraception in conjunction with spermicidal
       jelly or surgically sterile)

    -  No pregnancy or lactation

  Additional eligibility criteria for patients to be included in the radiotherapy substudy:

    -  R1 (microscopic positive margin)

    -  no previous radiotherapy to abdomen

Minimum age18 Years

GenderAll

Can Healthy volunteers participate?No

Contact details and further information

Sponsor Primary Sponsor Type: Other
Primary Sponsor Name: Universitätsklinikum Hamburg-Eppendorf

Trial websitehttps://clinicaltrials.gov/show/NCT02170090

Trial IDNCT02170090