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Sponsored by: |
Biogen Idec |
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Information provided by: | Biogen Idec |
ClinicalTrials.gov Identifier: | NCT00555724 |
Phase 1, open-labeled, dose escalation safety and tolerability study for the treatment of subjects with relapsed or refractory solid tumors.
Condition | Intervention | Phase |
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Solid Tumors |
Drug: BIIB022 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study |
Official Title: | A Phase 1, Open Label, Dose Escalation Study of BIIB022 (Anti-IGF-1R Monoclonal Antibody) in Subjects With Relapsed or Refractory Solid Tumors |
Estimated Enrollment: | 40 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | November 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Screening clinical laboratory values:
Contact: Biogen Idec | oncologyclinicaltrials@biogenidec.com |
United States, California | |
Research Site | Recruiting |
Los Angeles, California, United States | |
United States, Colorado | |
Research Site | Recruiting |
Aurora, Colorado, United States | |
United States, Pennsylvania | |
Research Site | Recruiting |
Philadelphia, Pennsylvania, United States |
Responsible Party: | Biogen Idec ( Pete Pieslor, MD ) |
Study ID Numbers: | 212ST101 |
Study First Received: | October 31, 2007 |
Last Updated: | November 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00555724 |
Health Authority: | United States: Food and Drug Administration |
Relapsed refractory solid tumor |
Antibodies, Monoclonal Antibodies Immunoglobulins |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |