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| Sponsor: | 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 |
| 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: | 20 |
| Study Start Date: | February 2008 |
| Estimated Study Completion Date: | January 2010 |
| Estimated Primary Completion Date: | October 2009 (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:
Exclusion Criteria:
Contacts and Locations| Contact: Biogen Idec | oncologyclinicaltrials@biogenidec.com |
| United States, Minnesota | |
| Research Site | Recruiting |
| Rochester, Minnesota, United States | |
| United States, New York | |
| Research Site | Recruiting |
| New York, New York, United States | |
More Information
| Responsible Party: | Biogen Idec ( Biogen Idec MD ) |
| Study ID Numbers: | 120GS201 |
| Study First Received: | February 8, 2008 |
| Last Updated: | July 14, 2009 |
| ClinicalTrials.gov Identifier: | NCT00618319 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Neoplasms Digestive System Diseases Neoplasms by Site Digestive System Neoplasms |
Gastrointestinal Diseases Gastrointestinal Neoplasms Gastrointestinal Stromal Tumors |