A Phase I Study of GC33 in Advanced or Metastatic Liver Cancer (Hepatocellular Carcinoma) - NCT00746317-48201 (Clinical Trial 240390)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy240390.aspx
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| City: |
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Detroit |
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State:
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MI |
| Zip Code: |
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48201 |
| Conditions: |
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Advanced or Metastatic HCC |
| Purpose: |
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This phase I trial is studying the safety and best dose of GC33 in patients with advanced or
metastatic liver cancer.
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| Study summary: |
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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: |
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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.
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:
- Anti coagulations 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. |
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| Study is available at: |
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Karmanos Cancer Center at the Detroit Medical Center
Detroit, MI 48201
United States
Primary Contact:
Ann M Ferris
Phone: 313-576-9373
Secondary Contact:
Toshihiko Ohtomo
Email: clinical-trials@chugai-pharm.co.jp |
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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: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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