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Study 13 of 63 for search of: | Australia, Australian Capital Territory |
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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00075218 |
A study to assess the safety and efficacy of SU11248 in patients with gastrointestinal stromal tumors (GIST) who have failed Gleevec therapy or who were intolerant to Gleevec treatment.
Condition | Intervention | Phase |
---|---|---|
Gastrointestinal Stromal Tumors |
Drug: SU011248 Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Of SU011248 In The Treatment Of Patients With Imatinib Mesylate (Gleevec Tm, Glivec)-Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor |
Enrollment: | 357 |
Study Start Date: | December 2003 |
Estimated Study Completion Date: | May 2008 |
Estimated Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Active Comparator |
Drug: SU011248
50 mg taken orally once a day. 6 week treatment cycle (Schedule 4/2) 4 weeks on study drug/2 weeks off study drug.
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B: Placebo Comparator |
Drug: Placebo
50 mg taken orally once a day. 6 week treatment cycle (Schedule 4/2) 4 weeks on study drug/2 weeks off study drug.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer Inc ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A6181004 |
Study First Received: | January 6, 2004 |
Last Updated: | November 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00075218 |
Health Authority: | United States: Food and Drug Administration |
Imatinib Digestive System Diseases Digestive System Neoplasms Sunitinib |
Gastrointestinal Diseases Gastrointestinal Neoplasms Gastrointestinal Stromal Tumors |
Neoplasms Neoplasms by Site Antineoplastic Agents Growth Substances Therapeutic Uses |
Physiological Effects of Drugs Growth Inhibitors Angiogenesis Modulating Agents Angiogenesis Inhibitors Pharmacologic Actions |