Sunitinib Plus Prednisone In Patients With Metastatic Castration-Resistant Prostate Cancer After Failure Of Docetaxel Chemotherapy

• Status: Terminated
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Docetaxel; Prednisone; Sunitinib

Criteria

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.