Status:
COMPLETED
Bicalutamide and Ridaforolimus in Men With Prostate Cancer (MK-8669-002)
Lead Sponsor:
Merck Sharp & Dohme LLC
Collaborating Sponsors:
Ariad Pharmaceuticals
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief 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.
Detailed Description
Ridaforolimus (MK8669/AP23573) was also known as deforolimus until May 2009.
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00777959
Start Date
October 1 2008
End Date
June 1 2011
Last Update
August 19 2015
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.