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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00338884 |
A phase II study to allow patients with advanced kidney cancer access to sunitinib malate treatment and to find out the good and bad effects of taking 37.5 mg sunitinib malate in a continuous daily regimen (once per day) for one year.
Condition | Intervention | Phase |
---|---|---|
Carcinoma, Renal Cell |
Drug: Sunitinib malate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Efficacy And Safety Study Of Sunitinib Malate (SU011248) Administered In A Continuous Daily Regimen In Patients With Advanced (First-Line) Renal Cell Cancer |
Estimated Enrollment: | 120 |
Study Start Date: | September 2006 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental |
Drug: Sunitinib malate
Sunitinib malate starting dose 37.5 mg daily continuous daily schedule
|
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 |
Argentina | |
Pfizer Investigational Site | Active, not recruiting |
Buenos Aires, Argentina, 1431 | |
Pfizer Investigational Site | Active, not recruiting |
Cordoba, Argentina, X5000AAI | |
Argentina, Santa Fé | |
Pfizer Investigational Site | Active, not recruiting |
Rosario, Santa Fé, Argentina, (2000) | |
Australia, South Australia | |
Pfizer Investigational Site | Recruiting |
Adelaide, South Australia, Australia, 5000 | |
Australia, Victoria | |
Pfizer Investigational Site | Recruiting |
East Bentleigh, Victoria, Australia, 3165 | |
Pfizer Investigational Site | Recruiting |
Clayton, Victoria, Australia, 3168 | |
Brazil, RS | |
Pfizer Investigational Site | Active, not recruiting |
Porto Alegre, RS, Brazil, 90610-000 | |
Brazil, SP | |
Pfizer Investigational Site | Active, not recruiting |
São Paulo, SP, Brazil, 01308-050 | |
Korea, Republic of | |
Pfizer Investigational Site | Active, not recruiting |
Seoul, Korea, Republic of, 120-752 | |
Pfizer Investigational Site | Active, not recruiting |
Seoul, Korea, Republic of, 110-744 | |
Mexico, Jalisco | |
Pfizer Investigational Site | Active, not recruiting |
Guadalajara, Jalisco, Mexico, 44280 | |
Mexico, Nuevo Leon | |
Pfizer Investigational Site | Active, not recruiting |
Monterrey, Nuevo Leon, Mexico, 64460 | |
Taiwan | |
Pfizer Investigational Site | Recruiting |
Taipei, Taiwan, 112 | |
Pfizer Investigational Site | Completed |
Tainan, Taiwan, 710 | |
Pfizer Investigational Site | Recruiting |
Taichung, Taiwan, 407 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer Inc ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A6181110 |
Study First Received: | June 16, 2006 |
Last Updated: | September 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00338884 |
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 |