SU011248 for Platinum-Refractory Urothelial Cancer Evaluation Trial
NCT00578526
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- Histologically/cytologically proven inoperable, metastatic or recurrent transitional cell carcinoma of the urothelial tract
- Mixed histology with predominant TCC allowed.
- Failed, intolerant or ineligible for cisplatin based chemo
- Measurable Disease (RECIST)Not previously irradiated.
- Recovered from previous acute treatment to grade 1(CTCAE Vers. 3.0)
- No weight loss >/- 10% within 28 days of day 0
- Adequate Organ Function
- Adenocarcinoma, squamous carcinoma or other histology without any components of
transitional carcinoma.
- Small cell histology
- More than one previous systemic chemo
- Excised metastases without remaining measureable disease
- Prior therapy with angiogenesis inhibitors
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Calgary, Alberta
- Edmonton, Alberta
- Vancouver, British Columbia
- Hamilton, Ontario
- London, Ontario
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | SU011248 for Platinum-Refractory Urothelial Cancer Evaluation Trial | |||
Official Title ICMJE | A Randomized, Placebo-controlled Phase II Study to Compare the Efficacy and Safety of SU011248 Versus Placebo in Patients With Advanced Urothelial Transitional Cell Carcinoma Who Have Failed or Are Intolerant to Cisplatin-based Chemotherapy | |||
Brief Summary | The purpose of this study is to find out if SU011248 works and if it is safe in patients with advanced transitional cell carcinoma. | |||
Detailed Description | The study objectives include the determination of the antitumor effect of SU011248 in patients with urothelial transitional cell carcinoma and to also determine the toxicities and tolerability of SU011248 in patients with urothelial transitional cell carcinoma who have failed or are intolerant to cisplatin-based chemotherapy. The primary endpoint of the study is to compare progression free survival at 4 months in patients who received SU011248 plus BSC versus patients who received placebo plus BSC The secondary endpoint is to compare the objective response rate and duration of response in patients who received SU011248 plus BSC versus patients who received placebo plus BSC, to describe the QOL and safety profile of SU011248 when compared to placebo and to describe the overall survival in patients who received SU011248 plus BSC versus patients who received placebo plus BSC | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Participant) Primary Purpose: Treatment | |||
Condition ICMJE |
| |||
Intervention ICMJE |
| |||
Study Arms ICMJE |
| |||
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 | 64 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | July 16, 2014 | |||
Actual Primary Completion Date | July 16, 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 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 | Canada | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00578526 | |||
Other Study ID Numbers ICMJE | SPRUCE02 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Tina Cheng, AHS Cancer Control Alberta | |||
Study Sponsor ICMJE | AHS Cancer Control Alberta | |||
Collaborators ICMJE | Pfizer | |||
Investigators ICMJE |
| |||
PRS Account | AHS Cancer Control Alberta | |||
Verification Date | August 2018 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |