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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00435409 |
The treatment received with sunitinib plus capecitabine could delay tumor growth longer than with treatment with capecitabine alone.
Condition | Intervention | Phase |
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Breast Neoplasms |
Drug: Sunitinib + Capecitabine Drug: Capecitabine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Phase 3 Study Of Sunitinib In Combination With Capecitabine Compared With Capecitabine In Patients With Previously Treated Breast Cancer |
Estimated Enrollment: | 430 |
Study Start Date: | February 2007 |
Estimated Study Completion Date: | February 2012 |
Estimated Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental |
Drug: Sunitinib + Capecitabine
Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m2 per day (1000 mg/m2 bid) from days 1-14 every 3 weeks. Study treatment should be given until progression or withdrawal from the study for other reasons. |
B: Active Comparator |
Drug: Capecitabine
Capecitabine administered orally at a starting dose of 2500 mg/m2 per day (1500 mg/m2 bid) from days 1-14 every 3 weeks. Study treatment should be given until progression or withdrawal from the study for other reasons. At the time of progression, patients may be eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily.
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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:
Contact: Pfizer Oncology Clinical Trial Information | (877) 369-9753 | PfizerCancerTrials@emergingmed.com |
Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer Inc ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A6181099 |
Study First Received: | February 13, 2007 |
Last Updated: | January 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00435409 |
Health Authority: | United States: Food and Drug Administration |
Capecitabine Skin Diseases Sunitinib |
Fluorouracil Breast Neoplasms Breast Diseases |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Immunosuppressive Agents |
Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents |