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Sponsored by: |
ImClone Systems |
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Information provided by: | ImClone Systems |
ClinicalTrials.gov Identifier: | NCT00786383 |
We are conducting a research study for tumors that have not responded to prior treatment. The subject will receive an investigational drug called IMC-1121B. ImClone Systems Incorporated, the maker of IMC-1121B, is running this research study.
We believe that IMC-1121B blocks the growth factors made by the cancer cells, so new blood vessels do not grow. It is believed that without the new blood vessels, the cancer or tumor will not get the oxygen and food that it needs to grow. This may stop the cancer from growing or spreading and the tumor cells may die. Since normal blood vessels have already formed in adults, it might be possible to stop tumor growth without harming normal cells.
Condition | Intervention | Phase |
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Cancer |
Biological: IMC-1121B |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Active Control, Single Group Assignment, Safety Study |
Official Title: | Phase 1 Study of Every Other Week Anti-Vascular Endothelial Growth Factor Receptor 2 (VEGFR-2) Monoclonal Antibody IMC-1121B in Patients With Advanced Solid Tumors Who Have Not Responded To Standard Therapy |
Estimated Enrollment: | 25 |
Study Start Date: | January 2006 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
IMC-1121B injectable solution at a concentration of 5 mg/mL in single-use vials containing 100 mg/20 mL or 250 mg/50 mL of product, administered intravenously at an initial dose of 6 mg/kg.
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Biological: IMC-1121B
IMC-1121B, administered intravenously, once every other week the starting dose will be 6 mg/kg in cohort 1.(cohorts 1 through 3) or once every 3 weeks intravenously, once every 3 weeks on day 1 of each treatment cycle, for a total of one dose per cycle. Patients will receive 15 mg/kg and 20 mg/kg in cohorts 4 and 5, respectively.(cohorts 4 and 5).
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We are conducting a research study for tumors that have not responded to prior treatment. The subject will receive an investigational drug called IMC-1121B. ImClone Systems Incorporated, the maker of IMC-1121B, is running this research study.
In order for a cancer to grow, it needs blood vessels to bring to it oxygen and food. Cancer cells can make growth factors that cause the abnormal growth of new blood vessels. This is called angiogenesis. Normally, new blood vessels do not grow in adults. Angiogenesis inhibitors are drugs that may prevent abnormal growth of blood vessels to tumors. IMC-1121B is an angiogenesis inhibitor. We believe that IMC-1121B blocks the growth factors made by the cancer cells, so new blood vessels do not grow. It is believed that without the new blood vessels, the cancer or tumor will not get the oxygen and food that it needs to grow. This may stop the cancer from growing or spreading and the tumor cells may die. Since normal blood vessels have already formed in adults, it might be possible to stop tumor growth without harming normal cells.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate hematologic function, as defined by:
Adequate hepatic function, as defined by:
Exclusion Criteria:
Uncontrolled intercurrent illness including, but not limited to:
United States, Indiana | |
Indiana Cancer Pavilion | |
Indianapolis, Indiana, United States, 46202-5112 |
Principal Investigator: | Gabriela Chiorean, MD | Indiana Cancer Pavilion |
Responsible Party: | ImClone Systems Incorporated ( Eric Rowinsky/ Chief Medical Officer ) |
Study ID Numbers: | CP12-0402 |
Study First Received: | November 4, 2008 |
Last Updated: | November 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00786383 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Phase I cancer solid tumors |
1121B VEGFR-2 Anti-Vascular Endothelial Growth Factor Receptor 2 |
Antibodies, Monoclonal Antibodies Immunologic Factors |
Mitogens Endothelial Growth Factors Immunoglobulins |
Antibodies, Monoclonal Molecular Mechanisms of Pharmacological Action Immunologic Factors Growth Substances Mitosis Modulators |
Physiological Effects of Drugs Mitogens Endothelial Growth Factors Pharmacologic Actions |