Status:
COMPLETED
A Phase I Study of GC33 in Advanced or Metastatic Liver Cancer (Hepatocellular Carcinoma)
Lead Sponsor:
Chugai Pharmaceutical
Conditions:
Advanced or Metastatic HCC
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This phase I trial is studying the safety and best dose of GC33 in patients with advanced or metastatic liver cancer.
Detailed Description
This is a Phase I open-label dose escalation study of GC33 in patients with advanced or metastatic HCC. This study is designed to evaluate safety, tolerability, pharmacokinetics, and preliminary asses...
Eligibility Criteria
Inclusion
- 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).
- 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: ≤ 3.0 × ULN
- Platelets: ≥ 50,000/μL
- Absolute Neutrophil Count: ≥ 1,500/μL
- Serum creatinine: ≤ 2.0 × ULN
- PT-INR: ≤ 2.0
- IHC confirmed GPC3-positive HCC tumor tissue. Tumor tissue sample may be provided by:
- A formalin fixed paraffin embedded block sample within 12 months prior to informed consent for HCC diagnosis;
- Unstained slides obtained within 3 months prior to informed consent for HCC diagnosis;
- Undergo biopsy to confirm GPC3-positive HCC.
- Resection samples are not acceptable.
- At least one measurable lesion based on Response Evaluation Criteria In Solid Tumors criteria.
Exclusion
- 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.
- Patients who received the following treatments within 2 weeks prior to Day 1:
- Anticoagulations 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.
- IHC confirmed GPC3-negative HCC tumor tissue.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00746317
Start Date
September 1 2008
End Date
October 1 2012
Last Update
October 17 2012
Active Locations (9)
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1
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
3
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
4
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115