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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00130897 |
To provide access to sunitinib to patients with metastatic renal cell carcinoma. People in this study will have been previously treated with cytokine therapy, e.g. interferon-alpha, but this is no longer effective.
Condition | Intervention | Phase |
---|---|---|
Carcinoma, Renal Cell |
Drug: sunitinib malate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A SU011248 Treatment Protocol For Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma Who Are Ineligible For Participation In Other SU011248 Protocols And May Derive Benefit From Treatment With SU011248 |
Estimated Enrollment: | 5000 |
Study Start Date: | June 2005 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A
Sutent 25, 37.5, or 50 mg daily
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Drug: sunitinib malate
sutent, 25, 37.5, or 50 mg daily
|
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 Service | 1-877-369-9753 | 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: | A6181037 |
Study First Received: | August 14, 2005 |
Last Updated: | December 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00130897 |
Health Authority: | United States: Food and Drug Administration |
Urogenital Neoplasms Renal cancer Urologic Neoplasms Kidney cancer Carcinoma Urologic Diseases Kidney Neoplasms |
Sunitinib Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Urinary tract neoplasm Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Antineoplastic Agents Growth Substances Therapeutic Uses |
Physiological Effects of Drugs Growth Inhibitors Angiogenesis Modulating Agents Angiogenesis Inhibitors Pharmacologic Actions |