Sunitinib Plus Prednisone In Patients With Metastatic Castration-Resistant Prostate Cancer After Failure Of Docetaxel Chemotherapy
NCT00676650
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- Histologically or cytologically confirmed adenocarcinoma of the prostate.
- Progressive, metastatic castration-resistant prostate cancer after failure of docetaxel chemotherapy (resistant or intolerant).
- Progressive disease based on PSA progression, RECIST, or positive bone scan.
- ECOG 0 or 1.
- Prior treatment with sunitinib and/or more than 1 prior chemotherapy regimen in the
metastatic disease setting.
- Chemotherapy within 3 weeks.
- Impending complications from bone metastases.
- Ongoing urinary obstruction.
- Cardiac dysfunction, QTc >470 msec.
- CNS involvement.
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Descriptive Information | ||||
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Brief Title ICMJE | Sunitinib Plus Prednisone In Patients With Metastatic Castration-Resistant Prostate Cancer After Failure Of Docetaxel Chemotherapy | |||
Official Title ICMJE | A Multicenter, Randomized, Double-Blind, Phase 3 Study Of Sunitinib Plus Prednisone Versus Prednisone In Patients With Progressive Metastatic Castration-Resistant Prostate Cancer After Failure Of A Docetaxel-Based Chemotherapy Regimen | |||
Brief Summary | This study will compare the safety and efficacy of sunitinib in combination with prednisone versus placebo and prednisone in patients that have metastatic castration-resistant prostate cancer that has progressed after treatment with a docetaxel-containing chemotherapy regimen. This is a second-line study. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||
Condition ICMJE | Prostatic Neoplasms | |||
Intervention ICMJE |
| |||
Study Arms ICMJE |
| |||
Publications * | Michaelson MD, Oudard S, Ou YC, Sengeløv L, Saad F, Houede N, Ostler P, Stenzl A, Daugaard G, Jones R, Laestadius F, Ullèn A, Bahl A, Castellano D, Gschwend J, Maurina T, Chow Maneval E, Wang SL, Lechuga MJ, Paolini J, Chen I. Randomized, placebo-controlled, phase III trial of sunitinib plus prednisone versus prednisone alone in progressive, metastatic, castration-resistant prostate cancer. J Clin Oncol. 2014 Jan 10;32(2):76-82. doi: 10.1200/JCO.2012.48.5268. Epub 2013 Dec 9. | |||
* 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 | Terminated | |||
Actual Enrollment ICMJE | 873 | |||
Original Estimated Enrollment ICMJE | 819 | |||
Actual Study Completion Date ICMJE | December 2011 | |||
Actual Primary Completion Date | December 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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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 | Australia, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Israel, Italy, Korea, Republic of, Peru, Poland, Portugal, Slovakia, Spain, Sweden, Taiwan, United Kingdom, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00676650 | |||
Other Study ID Numbers ICMJE | A6181120 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | February 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |