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A Phase I Study of GC33 in Advanced or Metastatic Liver Cancer (Hepatocellular Carcinoma) - NCT00746317-98104(Clinical Trial 240391)



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City:  Seattle
State:  
WA
Zip Code: 98104
Conditions: Advanced or Metastatic HCC
Purpose: This phase I trial is studying the safety and best dose of GC33 in patients with advanced or metastatic liver cancer.
Study summary: 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 assessment of anti-tumor activity. Enrollment will proceed until a maximum tolerated dose (MTD) and a recommended Phase II dose has been established.
Criteria: Inclusion Criteria: - 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 Criteria: - 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.
Study is available at: Swedish Cancer Institute at the Swedish Medical Center
Seattle, WA 98104
United States

Primary Contact:
Kimberly Pedersen
Email: Kimberly.pedersen@swedish.org
Phone: 206-386-6921

Secondary Contact:
Toshihiko Ohtomo
Email: clinical-trials@chugai-pharm.co.jp
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 22, 2011
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