A Phase I Study of GC33 in Advanced or Metastatic Liver Cancer (Hepatocellular Carcinoma)
NCT ID: NCT00746317
Last Updated: 2012-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
27 participants
INTERVENTIONAL
2008-09-30
2012-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
GC33
IV administration at 4 escalating dose levels.
Interventions
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GC33
IV administration at 4 escalating dose levels.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Chugai Pharmaceutical
INDUSTRY
Responsible Party
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Principal Investigators
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Toshihiko Ohtomo
Role: STUDY_CHAIR
Chugai Pharmaceutical
Locations
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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
Countries
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Other Identifiers
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GC-001US
Identifier Type: -
Identifier Source: org_study_id