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Sponsored by: |
Biogen Idec |
Information provided by: | Biogen Idec |
ClinicalTrials.gov Identifier: | NCT00618319 |
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
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Drug: BIIB021
Dose, schedule, and duration specified in protocol
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Required laboratory values:
Exclusion Criteria:
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 |
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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