Study of GC33 and Sorafenib in Combination in Advanced or Metastatic Liver Cancer (Hepatocellular Carcinoma)

Completed · Phase 1

Conditions studied: Hepatocellular Carcinoma

In brief

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.

Key facts

Study ID

NCT00976170

Run by

Chugai Pharmaceutical

People needed

42

Starts

2009-09-01

Expected to finish

2014-09-01

Last updated by the study team

2014-10-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• California Pacific Medical Center — San Francisco, California, United States
• University of Miami — Miami, Florida, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• National Cheng Kung University Hospital — Tainan, Taiwan
• National Taiwan Univercity Hospital — Taipei, Taiwan

Full record on ClinicalTrials.gov

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