Status:
COMPLETED
Study of GC33 and Sorafenib in Combination in Advanced or Metastatic Liver Cancer (Hepatocellular Carcinoma)
Lead Sponsor:
Chugai Pharmaceutical
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This phase I trial is studying the safety and best dose of GC33 and Sorafenib in combination in patients with advanced or metastatic liver cancer.
Detailed Description
This is a Phase I open-label dose escalation study of GC33 in combination with Sorafenib in patients with advanced or metastatic HCC. This study is designed to evaluate safety, tolerability, pharmacok...
Eligibility Criteria
Inclusion
- Signed written Institutional Review Board/Ethical Committee approved informed consent form.
- Male or female ≥18 years old.
- Life expectancy ≥3 months.
- ECOG Performance Status of 0-1.
- Histologically confirmed hepatocellular carcinoma.
- Not a candidate for curative treatments.
- Child-Pugh A
- Hematological, Biochemical and Organ Function:
- AST (SGOT): ≤5.0 × ULN,
- ALT (SGPT): ≤5.0 × ULN,
- Total Bilirubin: ≤1.5mg/dL,
- Platelets: ≥100,000/μL,
- Absolute Neutrophil Count: ≥1,500/μL,
- Serum creatinine: ≤2.0 × ULN,
- PT-INR: ≤2.0
- Ability to provide a tumor tissue sample either by:
- A formalin fixed paraffin embedded block sample within 12 months prior to informed consent for HCC diagnosis
- Undergo a biopsy to confirm HCC diagnosis
- Measurable disease.
Exclusion
- Child-Pugh B or C
- Patient who have taken Sorafenib previously.
- Difficulty or inability to swallow pills.
- Pregnant or lactating women or women of child-bearing potential and men of childbearing potential not willing to use effective means of contraception.
- Patients known to be positive for Human immunodeficiency virus infection.
- Active infectious diseases requiring treatment except for hepatitis B and C.
- Other malignancies within the last 5 years.
- History of transplantation (organ, bone marrow transplantation, Peripheral blood stem cell transplantation, etc.).
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements..
- Patients with known brain metastases or other central nervous system disease/disorders.
- Uncontrolled hypertension defined as systolic blood pressure \>150 mmhg or diastolic blood pressure \>90 mmHg, despite optimal medical management.
- Non-tumor related thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months.
- Pulmonary hemorrhage/bleeding event ≥ CTCAE Grade 3, any other hemorrhage/bleeding event ≥ CTCAE Grade 4 within 4 weeks of first dose of study drug.
- Serious non-healing wound, ulcer, or bone fracture.
- Patients who received major surgery, local therapy for HCC, chemotherapy, radiotherapy, hormone-therapy, immunotherapy, or another investigational drug within 4 weeks prior to Day 1(6 weeks for nitrosoureas, mitomycin, and bevacizumab; 1 week for tumor biopsy).
- Patients who received the following treatments within 2 weeks prior to Day 1:
- Anticoagulant or thrombolytic agents for therapeutic purposes,
- Systemic anti-viral therapy for hepatitis C and Interferon therapy for hepatitis B,
- Blood transfusion including all blood products
- Known history of hypersensitivity to similar agents.
- Patients receiving any medications or substances that are inducers of CYP3A4 are ineligible: rifampin, St. John's wort, phenytoin, carbamazepine, phenobarbital and dexamethasone.
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol requirements and/or follow-up procedures; those conditions should be discussed with the patient before trial entry.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00976170
Start Date
September 1 2009
End Date
September 1 2014
Last Update
October 3 2014
Active Locations (7)
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1
California Pacific Medical Center
San Francisco, California, United States, 94115
2
University of Miami
Miami, Florida, United States
3
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
4
University of North Carolina
Chapel Hill, North Carolina, United States