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Clinical Trial Details

A clinical trial to assess the safety, tolerability and efficacy of MG010 in combination with sorafenib-(Nexavar), in people with solid tumours who have failed existing treatments.

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Trial Information

Broad Health Condition Cancer
Cancer
Cancer
Cancer

Specific Health ConditionBowel - Back passage (rectum) or large bowel (colon)
Liver
Lung - Non small cell
Kidney

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW,QLD

Hospital
The Chris O’Brien Lifehouse - Camperdown
Scientia Clinical Research - Randwick
Concord Repatriation Hospital - Concord
Icon Cancer Care South Brisbane - South Brisbane


Postcode
2050 - Camperdown
2031 - Randwick
2139 - Concord
4101 - South Brisbane

Phase of TrialPhase 1 / Phase 2

Has the study received ethics approval?Further information iconApproved

Trial summary

This purpose of this study is to determine the safety, tolerability and efficacy of MG010 in combination with sorafenib in patients with solid tumors who have failed existing treatments 

Who is it for?
You may be eligible to join this study if you are aged between 18 years and above, and have histologically confirmed diagnosis of advanced or metastatic solid tumors for which standard treatment is unavailable/ineffective/intolerable

Study details
All participants in this study will receive MG010 and sorafenib. This study will have 2 stages: the dose escalation stage and the dose expansion stage.

In the dose escalation stage, there will be 3 groups of participants who each receive different doses of each drug. The drug will be given orally once every day of a 28-day cycle.

In the dose expansion stage, participants will receive once/twice a day MG010 and once daily sorafenib (at a dose determined from the dose escalation stage) for up to 6 28-day cycles.

Participants will be monitored for reactions and treatment effectiveness, and provide blood and urine for analysis. Medical imaging, e.g. PET and/or CAT scans for stage I will be performed at the beginning and the end. For stage II 5 images will be taken throughout the study; at screening, days, 56, 112, 168 and 210.

It is  hoped this trial will provide information on the treatment of solid tumours by demonstrating a benefit in the proposed combination treatment, by improving the tolerability and expand the usage of sorafenib in cancer treatment.
Eligibility

Key inclusion criteria

1.Age over 18 years
2.For subject to be enrolled in cohort 1 of dose-escalation stage:
Histologically confirmed diagnosis of  advanced or metastatic solid tumors for which standard treatment is unavailable/ineffective/intolerable.
3. For  subject  to  be  enrolled  in  additional  cohorts  of  dose-
escalation  stage  and  dose  expansion  cohort: Histologically confirmed diagnosis of one of the following advanced or metastatic solid tumours for which standard treatment is unavailable/ineffective/intolerable:
a.Non-small cell lung carcinoma
b.Renal cell carcinoma
c.Colorectal cancer, or 
d. Hepatocellular carcinoma with liver function of Child-Pugh Class A or B (score 7 only), who are resistant to sorafenib
4.Disease progression within 6 months after most recent standard therapy
5.ECOG performance status of  less than or equal to 2
6.Have at least one tumour lesion measurable in a unidimensional way with either spiral CT/PET or CT or MRI (in case of brain lesions) only according to Response Evaluation Criteria In Solid Tumours (RECIST 1.1)
7.Adequate organ function within 14 days prior to enrolment, as defined below:
a.Bilirubin less than or equal to x Upper Normal Limit (UNL)
b.AST/ALT/ALP < 5 x UNL 
c.Polynuclear neutrophils greater than or equal to 1 500/mm^3
d.Haemoglobin > 90g/L
e.Platelets greater than or equal to 100 000/mm^3
f.Serum Creatinine < 2 x UNL
g.GFR > 30 mL/min
8. .Adequate oral intake without the need for enteral or parenteral feeding
9.Life expectancy > 3 months
10.Ability to understand and willing to sign a written informed consent document and to comply with the study protocol
11.Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry, during the last study period and for the following 6 months after the last study drug intake. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
12.No known or suspected allergy or hypersensitivity to sorafenib or any component of the excipients of MG010
13.For subjects with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
14. Subjects  with  a  history  of  hepatitis  C  virus  (HCV)  infection must  have  been  treated  
and  cured.  For  subjects with  HCV infection  who are  currently on  treatment, they are  
eligible  if they have an undetectable HCV viral load

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

1.Surgery (except biopsy) within 4 weeks before enrolment
2.Received any chemotherapy, radiotherapy, targeted therapy or immunotherapy within 4 weeks prior to the enrolment
3.Archived tumour tissue, biopsy tissue or blood sample not available/not suitable for analysis of pDAPKS308 expression 
4.History of additional malignancies, except non-melanoma skin cancer, in situ cancer of the cervix, or other solid tumours thathave been considered cured for > 3 years
5.Participated in any other investigational trial, unless treatment in that trial has been discontinued at least 30 days prior to the enrolment
6.Known or suspected allergy or hypersensitivity to any of the therapeutic agents to be administered during the study
7.Uncontrolled concurrent illness including, but not limited to active infection, symptomatic congestive heart failure or cardiac arrhythmia
8.Known to have hypertension (systolic BP>180mmHg or diastolic BP>110mmHg)
9.Receiving inducers of CYP3A4 activity (for example, St. John’s wort, phenytoin, carbamazepine, phenobarbital, and dexamethasone) or sensitive substrates of CYP1A2, 1B1, 2C8, and 2C19 (e.g. theophylline, duloxetine, alosetron or tizanidine) within 2 weeks prior to the enrolment
10.Uncontrolled mental disease or psychotic manifestation that would prohibit compliance with the protocol, the understanding of the informed consent form or the ability to withdraw from the study
11.Malabsorption problem that may affect absorption of sorafenib or MG010
12.ActiveHIV, HBV or HCV infections 
13.Pregnancy or breast feeding
Contact details and further information

Sponsor Primary Sponsor Type: Commercial sector/Industry
Primary Sponsor Name: Metagone Biotech Australia Pty Ltd
Primary Sponsor Address: Metagone Biotech Australia Pty Ltd Suite 201, 134 William St Woolloomooloo NSW 2011
Primary Sponsor Country: Australia

Trial IDACTRN12620000849998

UTNU1111-1248-4265

Contact person for information and recruitmentA/Prof
Jim Coward
ICON CANCER CENTRE PO BOX 3787 SOUTH BRISBANE QLD 4141
+61 7 3737 4730

Further information icondrjcoward@icon.team
Australia