A Phase I Study of GC33 in Advanced or Metastatic Liver Cancer (Hepatocellular Carcinoma)

Completed · Phase 1

Conditions studied: Advanced or Metastatic HCC

In brief

This phase I trial is studying the safety and best dose of GC33 in patients with advanced or metastatic liver cancer.

Key facts

Study ID

NCT00746317

Run by

Chugai Pharmaceutical

People needed

27

Starts

2008-09-01

Expected to finish

2012-10-01

Last updated by the study team

2012-10-17

Who can join

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

You may qualify if…

• Signed written Institutional Review Board (IRB)/Ethical Committee (EC) approved informed consent form
• Male or female ≥ 18 years old.
• Life expectancy ≥ 3 months.
• ECOG Performance Status of 0-1.
• Histologically confirmed hepatocellular carcinoma (without fibrolamellar subtype).
• Not a candidate for curative treatments.
• Child-Pugh A or B.
• Hematological, Biochemical and Organ Function:
• AST (SGOT): ≤ 5.0 × ULN
• ALT (SGPT): ≤ 5.0 × ULN
• Total Bilirubin: ≤ 3.0 × ULN
• Platelets: ≥ 50,000/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 sample obtained within 3 months prior to informed consent for HCC diagnosis. Resection samples are not acceptable.
• undergo a biopsy to confirm HCC diagnosis
• At least one measurable lesion based on Response Evaluation Criteria In Solid Tumors criteria.
• (Extension Phase)
• Signed written Institutional Review Board (IRB)/Ethical Committee (EC) approved informed consent form.
• Male or female ≥ 18 years old.
• Life expectancy ≥ 3 months.
• ECOG Performance Status of 0-1.
• Histologically confirmed hepatocellular carcinoma (without fibrolamellar subtype).

You may not qualify if…

• Child-Pugh C.
• 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.).
• Patients with significant concomitant disease determined by the investigator to be potentially aggravated by the investigational drug.
• Patients with brain metastases, other central nervous system or other psychiatric disease.
• 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.
• Patients who received the following treatments within 2 weeks prior to Day1:
• Anticoagulant or thrombolytic agents for therapeutic purposes.
• Systemic anti-viral therapy for hepatitis C/cirrhosis.
• Blood transfusion
• History of hypersensitivity to similar agents.
• Patient is unable to comply with the requirements of the protocol and/or follow-up procedures.
• (Extension Phase)
• Child-Pugh B or C.
• 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.).
• Patients with significant concomitant disease determined by the investigator to be potentially aggravated by the investigational drug.
• Patients with brain metastases, other central nervous system or other psychiatric disease.
• 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.

Where it is running

• USC/Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Karmanos Cancer Center at the Detroit Medical Center — Detroit, Michigan, United States
• Washington University — St Louis, Missouri, United States
• Columbia University Medical Center — New York, New York, United States
• Methodist Hospital — Houston, Texas, United States
• Swedish Cancer Institute at the Swedish Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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