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Sponsored by: |
ImClone Systems |
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Information provided by: | ImClone Systems |
ClinicalTrials.gov Identifier: | NCT00782002 |
The purpose of this study is to determine if IMC-18F1 is safe for patients, and also to determine the best dose of IMC-18F1 to give to patients.
Condition | Intervention | Phase |
---|---|---|
Advanced Solid Tumors |
Biological: IMC-18F1 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase 1 Study of Weekly Anti-Vascular Endothelial Growth Factor Receptor 1 (VEGFR-1) Monoclonal Antibody IMC-18F1 in Patients With Advanced Solid Tumors Who No Longer Respond to Standard Therapy or For Whom No Standard Therapy is Available |
Estimated Enrollment: | 30 |
Study Start Date: | July 2006 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Biological: IMC-18F1
Cohorts 1-4 will receive IMC-18F1 intravenously for 4 weekly infusions, followed by a 2-week observation period. Cohort 5 will receive IMC-18F1 intravenously every other week for the first 6 weeks of therapy. Cohort 6 will receive IMC-18F1 every 3 weeks for the first 6 weeks for therapy. The starting dose in Cohort 1 will be 2mg/kg. The maximum dose of IMC-18F1 will not exceed 16mg/kg administered every week, 15mg/kg administered every other week, and 20mg/kg administered every 3 weeks. Dose escalation of 100% (2 x previous dose) if no dose limiting toxicities (DLTs) are observed in the first three patients within a cohort during the initial 6-week therapy period. Dose escalation increment will be reduced to 50% (1.5 x previous dose) following the occurrence of either grade 2 or higher AEs in 2 or more patients that are possibly, probably, or definitely-related to study medication or one DLT during the initial 6-week therapy period. No intrapatient dose escalation is allowed.
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The purpose of this study will be to establish the safety profile and the maximum tolerated dose (MTD) of the anti-VEGFR-1 monoclonal antibody IMC-18F1 administered weekly, every other week, or every three weeks in patients with advanced solid tumors who have not responded to standard therapy or for whom no standard therapy is available.
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:
Contact: Cynthia Amatangelo, , RN, BS | 908-239-0724 | Cynthia.amatangelo@imclone.com |
Contact: Paul Windt | 908-541- 8151 | Paul E.Windt@ImClone.com |
United States, Michigan | |
Karmanos Cancer Center | Recruiting |
Detroit, Michigan, United States, 48201 | |
Contact: Karen Forman 313-576-8716 formank@karmanos.org | |
Contact: Cynthia Amatangelo, RN, BS 908-239-0724 Cynthia.amatangelo@imclone.com | |
Principal Investigator: Patricia LoRusso, DO | |
United States, Ohio | |
Case Western University University Hospitals of Cleveland | Recruiting |
Cleveland, Ohio, United States, 44106 | |
Contact: Kristi Beatty 216-844-5546 kristi.beatty@uhhospitals.org | |
Principal Investigator: Smitha Krishnamurthi, MD |
Responsible Party: | ImClone Systems Incorporated ( Eric Rowinsky/ Chief Medical Officer ) |
Study ID Numbers: | CP14-0501 |
Study First Received: | October 27, 2008 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00782002 |
Health Authority: | United States: Food and Drug Administration |
Solid Tumors VEGF-A stromal cells endothelial cells malignant cells |
Antibodies, Monoclonal Antibodies Endothelial Growth Factors Immunoglobulins |