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| Sponsored by: |
Biogen Idec |
| Information provided by: | Biogen Idec |
| ClinicalTrials.gov Identifier: | NCT00618319 |
Purpose
This study will examine the effect of BIIB021 on GIST growth and metabolism.
| Condition | Intervention | Phase |
|
GIST |
Drug: BIIB021 |
Phase II |
| MedlinePlus related topics: | Cancer |
| ChemIDplus related topics: | Sunitinib Sunitinib malate Imatinib Imatinib mesylate Fluorodeoxyglucose F18 |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment |
| Official Title: | An Open-Label, 18FDG-PET Pharmacodynamic Assessment of the Effect of BIIB021 in Subjects With Gastrointestinal Stromal Tumors (GIST) Refractory to, Intolerant of, or Not a Candidate for Imatinib and Sunitinib Treatment |
| Estimated Enrollment: | 60 |
| Study Start Date: | February 2008 |
| Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
1: Experimental
BIIB021
|
Drug: BIIB021
Dose, schedule, and duration specified in protocol
|
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Required laboratory values:
Exclusion Criteria:
Contacts and Locations| Contact: Biogen Idec | oncologyclinicaltrials@biogenidec.com |
| United States, Minnesota | |||||
| Research Site | Not yet recruiting | ||||
| Rochester, Minnesota, United States | |||||
| United States, New York | |||||
| Research Site | Recruiting | ||||
| New York, New York, United States | |||||
| Biogen Idec |
More Information
| Responsible Party: | Biogen Idec ( Biogen Idec MD ) |
| Study ID Numbers: | 120GS201 |
| First Received: | February 8, 2008 |
| Last Updated: | March 18, 2008 |
| ClinicalTrials.gov Identifier: | NCT00618319 |
| Health Authority: | United States: Food and Drug Administration |
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