Advanced or Metastatic HCC Clinical Trial
Official title:
A Phase I, Open-Label, Multi-center, Dose-escalation Study of the Safety, Tolerability, and Pharmacokinetics of GC33 Administered Weekly in Patients With Advanced or Metastatic Hepatocellular Carcinoma (HCC)
| Verified date | October 2012 |
| Source | Chugai Pharmaceutical |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
This phase I trial is studying the safety and best dose of GC33 in patients with advanced or metastatic liver cancer.
| Status | Completed |
| Enrollment | 27 |
| Est. completion date | October 2012 |
| Est. primary completion date | October 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
| United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
| United States | Massachusetts General Hospital | Boston | Massachusetts |
| United States | Karmanos Cancer Center at the Detroit Medical Center | Detroit | Michigan |
| United States | Methodist Hospital | Houston | Texas |
| United States | USC/Norris Comprehensive Cancer Center | Los Angeles | California |
| United States | Columbia University Medical Center | New York | New York |
| United States | Swedish Cancer Institute at the Swedish Medical Center | Seattle | Washington |
| United States | Washington University | St. Louis | Missouri |
| Lead Sponsor | Collaborator |
|---|---|
| Chugai Pharmaceutical |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Determine the safety and tolerability of escalating doses of GC33 | Continuously | Yes | |
| Secondary | Characterize the pharmacokinetics of GC33 | Continuously | No | |
| Secondary | Perform a preliminary assessment of anti-tumor activity of GC33 | Continuously | No |