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Sponsored by: |
ImClone Systems |
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Information provided by: | ImClone Systems |
ClinicalTrials.gov Identifier: | NCT00627042 |
The single arm, multicenter, open-label, phase II study will enroll up to 40 chemotherapy-naive patients with historically confirmed cancer of the liver that cannot be treated with surgery.
Condition | Intervention | Phase |
---|---|---|
Hepatocellular Carcinoma |
Biological: IMC-1121B |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open Label, Multicenter, Phase 2 Study Evaluating the Safety and Efficacy of IMC-1121B as First Line Monotherapy in Patients With Unresectable Hepatocellular Cancer. |
Estimated Enrollment: | 40 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Biological: IMC-1121B
Patients will receive IMC-1121B at 8 mg/kg administered over 1 hour every other week (every 14 days). Treatment will continue until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.
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Inhibition of angiogenesis is considered a promising approach to the treatment of cancer. Members of the VEGF family and the VEGFR-2 are important mediators of angiogenesis and are likely important therapeutic targets in advanced HCC.
Angiogenesis appears integral to HCC development and pathogenesis. Angiogenesis inhibition has been efficacious in both in vitro and in vivo HCC models and results of clinical studies also suggest potential to inhibit disease growth.
IMC-1121B is a fully human MAb that specifically binds to the extracellular domain of VEGFR-2 with high affinity. Phase 1 studies currently nearing completion have demonstrated safety and tolerability at clinically relevant doses, with preliminary evidence of clinical efficacy in a variety of human cancers.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
UCLA Dept of Medicine, Division of Hematology/Oncology | |
Los Angeles, California, United States, 90095 | |
United States, Illinois | |
Northwestern University Feinberg School of Medicine | |
Chicago, Illinois, United States, 60611 | |
United States, Louisiana | |
Jayne Gurtler | |
Metairie, Louisiana, United States, 70006 | |
United States, Massachusetts | |
Lahey Clinic Medical Center | |
Burlington, Massachusetts, United States, 01805 | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
United States, Pennsylvania | |
Abramson Cancer Center of the University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 |
Principal Investigator: | Keith Stuart, MD | Lahey Clinic Medical Center |
Responsible Party: | ImClone System, Incorporated ( Eric Rowinsky/ Chief Medical Officer ) |
Study ID Numbers: | CP12-0710 |
Study First Received: | February 18, 2008 |
Last Updated: | January 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00627042 |
Health Authority: | United States: Food and Drug Administration |
Liver disease Neoplasms Liver neoplasms Carcinoma, Hepatocellular |
Liver Neoplasms Liver Diseases Digestive System Diseases Digestive System Neoplasms Carcinoma, Hepatocellular Liver neoplasms |
Gastrointestinal Neoplasms Adenocarcinoma Hepatocellular carcinoma Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type |