Bicalutamide and Ridaforolimus in Men With Prostate Cancer (MK-8669-002)

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: Male

Summary

This study will look to see if the combination of ridaforolimus and bicalutamide works better than placebo and bicalutamide in men with prostate cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Collaborator: Ariad Pharmaceuticals
• Treatments: Bicalutamide; Sirolimus

Criteria

Inclusion Criteria:

• Confirmed adenocarcinomas of the prostate.

• Evidence of metastatic disease

• Evidence of disease progression including one of the following: increasing levels of PSA, progressive lymph node disease, or worsening bone scan

• PSA level is greater or equal to 7 ng/ml.

• ECOG performance status less than or equal to 1

Exclusion Criteria :

• Previously received bicalutamide, flutamide, or nilutamide within the past 12 months (except for a period of use less than 30 days long).

• Prior chemotherapy for prostate cancer

• Prior rapamycin or rapamycin analogs, including ridaforolimus, everolimus, or temsirolimus.

• Patient is receiving an opioid or narcotic analgesic for pain due to prostate cancer

• Patient has pain related to prostate cancer that warrants the initiation of chemotherapy