| Sunitinib Plus Prednisone In Patients With Metastatic Castration-Resistant Prostate Cancer After Failure Of Docetaxel Chemotherapy |
| 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 |
| 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. |
| Not Provided |
| Interventional |
| Phase 3 |
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment |
| Prostatic Neoplasms |
- Drug: Prednisone
5 mg BID, oral
Other Name: Deltasone
- Drug: sunitinib
37.5 mg/day, oral, administered on a continuous daily dosing regimen
Other Name: Sutent, SU011248
- Drug: Placebo
37.5 mg/day, oral, administered on a continuous daily dosing regimen
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| 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. |
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| Terminated |
| 873 |
| December 2011 |
| December 2011 (Final data collection date for primary outcome measure) |
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Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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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| Sexes Eligible for Study: |
Male |
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| 18 Years and older (Adult, Senior) |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| 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 |
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| NCT00676650 |
| A6181120 |
| Yes |
| Not Provided |
| Not Provided |
| Pfizer |
| Pfizer |
| Not Provided |
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
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| Pfizer |
| February 2013 |
