Sunitinib Plus Prednisone In Patients With Metastatic Castration-Resistant Prostate Cancer After Failure Of Docetaxel Chemotherapy
Stopped early · Phase 3 · Has a placebo group
Conditions studied: Prostatic Neoplasms
In brief
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.
Key facts
- Study ID
- NCT00676650
- Run by
- Pfizer
- People needed
- 873
- Starts
- 2008-07-01
- Expected to finish
- 2011-12-01
- Last updated by the study team
- 2013-03-08
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Pfizer Investigational Site — Huntsville, Alabama, United States
- Pfizer Investigational Site — Huntsville, Alabama, United States
- Pfizer Investigational Site — Anaheim, California, United States
- Pfizer Investigational Site — Encinitas, California, United States
- Pfizer Investigational Site — Glendale, California, United States
- Pfizer Investigational Site — La Jolla, California, United States
- Pfizer Investigational Site — Los Angeles, California, United States
- Pfizer Investigational Site — Modesto, California, United States
- Pfizer Investigational Site — Thousand Oaks, California, United States
- Pfizer Investigational Site — Thousands Oaks, California, United States
- Pfizer Investigational Site — Vista, California, United States
- Pfizer Investigational Site — Westlake Village, California, United States
- Pfizer Investigational Site — Denver, Colorado, United States
- Pfizer Investigational Site — Lafayette, Colorado, United States
- Pfizer Investigational Site — Gainesville, Florida, United States
- Pfizer Investigational Site — Orlando, Florida, United States
- Pfizer Investigational Site — Winter Park, Florida, United States
- Pfizer Investigational Site — Arlington Heights, Illinois, United States
- Pfizer Investigational Site — Niles, Illinois, United States
- Pfizer Investigational Site — Winfield, Illinois, United States
- Pfizer Investigational Site — Zion, Illinois, United States
- Pfizer Investigational Site — Carmel, Indiana, United States
- Pfizer Investigational Site — Fishers, Indiana, United States
- Pfizer Investigational Site — Greenfield, Indiana, United States
- Pfizer Investigational Site — Decatur, Alabama, United States
Full record on ClinicalTrials.gov
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