Study of SU011248 in Patients With Advanced Kidney Cancer
NCT00254540
ABOUT THIS STUDY
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- Histologically proven renal cell carcinoma with metastases with a component of clear cell histology
- Any cellular therapy (LAK, TIL, DC), any vaccine therapy, mini-transplantation, or
systemic molecular-targeting therapy for RCC.
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Descriptive Information | ||||
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Brief Title ICMJE | Study of SU011248 in Patients With Advanced Kidney Cancer | |||
Official Title ICMJE | Phase II Study Of Single-Agent SU011248 In The Treatment Of Patients With Renal Cell Carcinoma | |||
Brief Summary | To determine the objective tumor response of single-agent SU011248 at a dose of 50 mg orally once daily for 4 consecutive weeks and 2 weeks rest, repeated every 6 weeks in patients with metastatic Renal Cell Cancer (RCC). | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Carcinoma, Renal Cell | |||
Intervention ICMJE | Drug: SU011248 capsule
50mg, PO on day 28 of each 42 day cycle, until progression or unacceptable toxicity develops | |||
Study Arms ICMJE | Experimental: SU-011248 capsule
Intervention: Drug: SU011248 capsule | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 51 | |||
Original Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | February 2009 | |||
Actual Primary Completion Date | February 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 20 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Japan | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00254540 | |||
Other Study ID Numbers ICMJE | A6181072 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer Inc | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | February 2010 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |