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| Sponsor: | Biogen Idec |
|---|---|
| Information provided by: | Biogen Idec |
| ClinicalTrials.gov Identifier: | NCT00555724 |
Purpose
Phase 1, open-labeled, dose escalation safety and tolerability study for the treatment of subjects with relapsed or refractory solid tumors.
| Condition | Intervention | Phase |
|---|---|---|
|
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: | January 2010 |
| Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| BIIB022: Experimental |
Drug: BIIB022
IV infusion once every three weeks until disease progression or unacceptable toxicity
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
Contacts and Locations| 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 | |
More Information
| Responsible Party: | Biogen Idec ( Study MD ) |
| Study ID Numbers: | 212ST101 |
| Study First Received: | October 31, 2007 |
| Last Updated: | July 10, 2009 |
| ClinicalTrials.gov Identifier: | NCT00555724 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Relapsed refractory solid tumor |
|
Antibodies, Monoclonal Neoplasms Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |