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Study 16 of 2219 for search of: | received on or after 11/14/2008 |
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Sponsored by: |
MedImmune LLC |
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Information provided by: | MedImmune LLC |
ClinicalTrials.gov Identifier: | NCT00816400 |
Evaluate the safety and tolerability of MEDI-575 in adult subjects with advanced solid tumors refractory to standard therapy or for which no standard therapy exists.
Condition | Intervention | Phase |
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Cancer |
Drug: MEDI-575 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety Study |
Official Title: | A Phase 1, Multicenter, Open-Label, Single-Arm, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Antitumor Activity of MEDI-575, a Fully Human Monoclonal Antibody Directed Against Platelet-Derived Growth Factor Receptor Alpha (PDGFRα), in Subjects With Advanced Solid Tumors Refractory to Standard Therapy or for Which No Standard Therapy Exists |
Estimated Enrollment: | 42 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | July 2011 |
Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
MEDI-575 (Dose escalation Cohort)
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Drug: MEDI-575
Administered at a dose determined by the subject's enrollment cohort as a 60 min. IV infusion as part of a 21 day treatment cycle.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jill Schmidt | 301-398-0000 | SchmidtJ@medimmune.com |
Contact: Susan Sloan | 301-398-0000 | SloanS@medimmune.com |
United States, Colorado | |
Rocky Mountain Cancer Center | |
Denver, Colorado, United States, 80218 | |
United States, Indiana | |
Central Indiana Cancer Center | |
Indianapolis, Indiana, United States, 46219 | |
United States, Nevada | |
Comprehensive Cancer Center of Nevada | |
Las Vegas, Nevada, United States, 89169 | |
United States, Texas | |
Texas Oncology P.A. | |
Dallas, Texas, United States, 75246 | |
United States, Virginia | |
Virginia Oncology Associates | |
Norfolk, Virginia, United States, 23502 |
Responsible Party: | Medimmune LLC ( Robert Lechleider, MD ) |
Study ID Numbers: | MI-CP187 |
Study First Received: | December 23, 2008 |
Last Updated: | December 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00816400 |
Health Authority: | United States: Food and Drug Administration |
Antibodies, Monoclonal Antibodies Immunoglobulins |