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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00706706 |
To investigate safety and efficacy of single agent sunitinib malate as first-line systemic therapy in Chinese patients with metastatic renal cell carcinoma.
Condition | Intervention | Phase |
---|---|---|
Carcinoma, Renal Cell |
Drug: Sunitinib Malate (SU011248) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Single-Arm, Open-Label, Multi-Center, Phase Iv, Safety And Efficacy Study Of Sunitinib Malate As First-Line Systemic Therapy In Chinese Patients With Metastatic Renal Cell Carcinoma (Post Approval Commitment Study) |
Estimated Enrollment: | 100 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | October 2012 |
Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
sunitinib: Experimental
single agent sunitinib, single arm
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Drug: Sunitinib Malate (SU011248)
Subjects will receive treatment with sunitinib in repeated 6-week cycles (4 weeks on, 2 weeks off), at a starting dose of 50 mg.
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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 Service | 1-877-369-9753 | PfizerCancerTrials@emergingmed.com |
Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
China | |
Pfizer Investigational Site | Recruiting |
Shanghai, China, 200127 | |
Pfizer Investigational Site | Recruiting |
Shanghai, China, 200032 | |
Pfizer Investigational Site | Recruiting |
Beijing, China, 100034 | |
Pfizer Investigational Site | Recruiting |
Beijing, China, 100021 | |
Pfizer Investigational Site | Recruiting |
Beijing, China, 100036 | |
Pfizer Investigational Site | Recruiting |
Tianjin, China, 300060 | |
China, Guangdong | |
Pfizer Investigational Site | Recruiting |
Guangzhou, Guangdong, China, 510060 | |
China, HuBei | |
Pfizer Investigational Site | Not yet recruiting |
Wuhan, HuBei, China, 430030 | |
China, Jiangsu | |
Pfizer Investigational Site | Recruiting |
Nanjing, Jiangsu, China, 210002 | |
China, Shan Xi | |
Pfizer Investigational Site | Recruiting |
Xi'an, Shan Xi, China, 710032 | |
China, Si chuan | |
Pfizer Investigational Site | Not yet recruiting |
Chong qing, Si chuan, China, 400038 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A6181132 |
Study First Received: | June 25, 2008 |
Last Updated: | January 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00706706 |
Health Authority: | China: State of Food and Drug Administration |
sunitinib, Phase IV, metastatic renal cell carcinoma, Chinese |
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 |