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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00746317
Recruitment Status : Completed
First Posted : September 3, 2008
Last Update Posted : October 17, 2012
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Advanced or Metastatic HCC Drug: GC33 Phase 1

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 assessment of anti-tumor activity. Enrollment will proceed until a maximum tolerated dose (MTD) and a recommended Phase II dose has been established.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Study Start Date : September 2008
Primary Completion Date : October 2010
Study Completion Date : October 2012
Arms and Interventions

Arm Intervention/treatment
Experimental: 1 Drug: GC33
IV administration at 4 escalating dose levels.


Outcome Measures

Primary Outcome Measures :
  1. Determine the safety and tolerability of escalating doses of GC33 [ Time Frame: Continuously ]

Secondary Outcome Measures :
  1. Characterize the pharmacokinetics of GC33 [ Time Frame: Continuously ]
  2. Perform a preliminary assessment of anti-tumor activity of GC33 [ Time Frame: Continuously ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00746317


Locations
United States, California
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Michigan
Karmanos Cancer Center at the Detroit Medical Center
Detroit, Michigan, United States, 48201
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63110
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
United States, Texas
Methodist Hospital
Houston, Texas, United States, 77030
United States, Washington
Swedish Cancer Institute at the Swedish Medical Center
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Chugai Pharmaceutical
Investigators
Study Chair: Toshihiko Ohtomo Chugai Pharmaceutical
More Information

Responsible Party: Chugai Pharmaceutical
ClinicalTrials.gov Identifier: NCT00746317     History of Changes
Other Study ID Numbers: GC-001US
First Posted: September 3, 2008    Key Record Dates
Last Update Posted: October 17, 2012
Last Verified: October 2012

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases