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Keyword: Cholangiocarcinoma
Broad Health Condition: Cancer
Specific Condition: Biliary tree (gall bladder and bile duct)
Recruitment Status: Recruiting
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)
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
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
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 5000Acticca1@ctc.usyd.edu.au
Australia
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
Recruitment statusRecruiting
Recruitment Details
Recruitment State
NSW,
Hospital
St George Private Hospital
Hospital
Sydney Southwest Private Hospital
Anticipated date of first participant enrolment1/07/2020
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
Sponsor Primary Sponsor Type: Commercial sector/Industry
Primary Sponsor Name: Quadriga Biosciences, Inc.
Trial websitehttps://clinicaltrials.gov/show/NCT04430842
Trial IDNCT04430842
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
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
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. 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 =10 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 partial thromboplastin time (PTT) <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 the excipients contained in NUC-1031 or diluent solution (dimethylacetamide [DMA], Kolliphor ELP, Tween 80). 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, low grade prostate cancer not requiring treatment or other solid tumours curatively treated with no evidence of disease for =3 years. 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
Sponsor Primary Sponsor Type: Other
Primary Sponsor Name: NuCana plc
Trial websitehttps://clinicaltrials.gov/show/NCT04163900
Trial IDNCT04163900
Trial summary
Study consists of an open-label, safety run-in part and a randomized, double-blind, placebo-controlled Phase 2/3 part. In the Phase 2/3 part, the study will evaluate whether bintrafusp alfa in combination with the current standard of care (SoC) (gemcitabine plus cisplatin) improves overall survival (OS) in chemotherapy and immunotherapy-naïve participants with locally advanced or metastatic BTC compared to placebo, gemcitabine and cisplatin.
Broad Health ConditionMetastatic Biliary Tract Cancer
Cholangiocarcinoma
Gallbladder Cancer
Ampullary cancer
M7824
Bintrafusp alfa
Transforming growth factor-beta
Programmed death-ligand 1
INTR@PID
Specific Health ConditionCancer
Biliary Tract Cancer
Cholangiocarcinoma
Gallbladder Cancer
Recruitment statusRecruiting
Recruitment Details
Recruitment State
NSW,QLD,VIC,
Hospital
Blacktown Hospital - PARENT
Key inclusion criteria
Inclusion Criteria: - Are participants with histologically or cytologically confirmed locally advanced or metastatic BTC - Participants must have available tumor tissue (primary or metastatic) (archival or fresh biopsies) before the first administration of study treatment - At least 1 measurable lesion according to RECIST 1.1 - Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 at study entry and at Week 1, Day 1 prior to dosing - Life expectancy of >= 12 weeks, as judged by the Investigator - Adequate hematological function, hepatic function, renal function, coagulation function as defined in the protocol - Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) positive participants must be treated and on a stable dose of antivirals - Other protocol defined inclusion criteria could apply Exclusion Criteria: - Previous and/or intercurrent cancers - Receipt of any organ transplantation, including allogeneic stem-cell transplantation, but with the exception of transplants that do not require immunosuppression - Participants with symptomatic central nervous system (CNS) metastases - Significant acute or chronic infection including known history of positive test for human immunodeficiency virus (HIV), active tuberculosis, uncontrolled biliary infection and active bacterial or fungal infection requiring systemic therapy (with the exception of hepatitis B and hepatitis C) requiring systemic therapy at study entry and at Week 1 Day 1 prior to dosing. - Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent - History of or concurrent interstitial lung disease - History of hypersensitivity reactions to bintrafusp alfa, anaphylaxis, or recent (within 5 months) uncontrolled asthma, cardiovascular/cerebrovascular disease - Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before randomization - Prior therapy with any antibody/drug targeting T-cell coregulatory proteins (immune checkpoints) - Other protocol defined exclusion criteria could apply
Minimum age18 Years
GenderAll
Sponsor Primary Sponsor Type: Commercial sector/Industry
Primary Sponsor Name: EMD Serono Research & Development Institute, Inc.
Trial websitehttps://clinicaltrials.gov/show/NCT04066491
Trial IDNCT04066491
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. All participants will be enrolled into initial tumor-specific cohorts (except those with pancreatic cancer) before the cohorts will be expanded, if adequate efficacy is determined.
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
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)
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 received 3 prior lines of therapy. Note: The initial 30 participants in this cohort included participants with primary ovarian cancer. The expanded cohort will include participants with primary ovarian cancer, fallopian tube, and peritoneal ovarian cancer. 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 presence of gastrointestinal condition including malabsorption 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 major blood vessel invasion/infiltration. Participants with portal vein invasion (Vp4), inferior vena cava, or cardiac involvement based on imaging in the BTC cohort are excluded - 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. - 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 (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
Sponsor Primary Sponsor Type: Commercial sector/Industry
Primary Sponsor Name: Merck Sharp & Dohme Corp.
Trial websitehttps://clinicaltrials.gov/show/NCT03797326
Trial IDNCT03797326
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 gene fusions/translocations. 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
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
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 - Documented FGFR2 gene fusions/translocations - Have an archival tissue sample available with sufficient tumor for central FGFR2 fusion/translocation molecular testing. However, if an archival tissue sample is not available, a newly obtained (before randomization) tumor biopsy may be submitted instead. - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 - Able to swallow and retain oral medication - Willingness to avoid pregnancy or father children Exclusion Criteria: - Received treatment with any systemic anti-cancer therapy for unresectable locally advanced or metastatic cholangiocarcinoma. Prior neoadjuvant or adjuvant therapy is permitted if completed > 6 months after the last dose of neoadjuvant or adjuvant therapy. - 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 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
Minimum age18 Years
GenderAll
Sponsor Primary Sponsor Type: Commercial sector/Industry
Primary Sponsor Name: QED Therapeutics, Inc.
Trial websitehttps://clinicaltrials.gov/show/NCT03773302
Trial IDNCT03773302
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
Recruitment statusRecruiting
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 for the course of the study through 120 days after the last dose of study treatment - Male participants with partners of must childbearing potential must be willing to use adequate contraception for the course of the study through 120 days after the last dose of study treatment 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 - History of non-infectious pneumonitis that required steroids or current pneumonitis - 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
Sponsor Primary Sponsor Type: Commercial sector/Industry
Primary Sponsor Name: Merck Sharp & Dohme Corp.
Trial websitehttps://clinicaltrials.gov/show/NCT02628067
Trial IDNCT02628067
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
Anaplastic Large Cell Lymphoma
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
Recruitment statusRecruiting
Recruitment Details
Recruitment State
NSW,SA,VIC,
Hospital
Liverpool Hospital
Hospital
Newcastle Private Hospital
Hospital
Austin Hospital
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 - Note: Patients diagnosed with anaplastic large cell lymphoma (ALCL) harboring a gene rearrangement of interest may be eligible provided they meet all other inclusion/exclusion criteria - 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, bone metabolism alterations or osteopenia - 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
Sponsor Primary Sponsor Type: Commercial sector/Industry
Primary Sponsor Name: Hoffmann-La Roche
Trial websitehttps://clinicaltrials.gov/show/NCT02568267
Trial IDNCT02568267
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
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
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
Sponsor Primary Sponsor Type: Other
Primary Sponsor Name: Universitätsklinikum Hamburg-Eppendorf
Trial websitehttps://clinicaltrials.gov/show/NCT02170090
Trial IDNCT02170090