Official Title: “A Phase II Randomized, Placebo Controlled Clinical Trial to Study the Efficacy and Safety of Bicalutamide With or Without Deforolimus (Ridaforolimus) in Men With Asymptomatic, Metastatic Castrate-Resistant Prostate Cancer”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: August 2010

Ridaforolimus (MK8669/AP23573) was also known as deforolimus until May 2009

Intervention(s) in this Clinical Trial

• Drug: ridaforolimus (MK8669)
  • Four 10 mg tablets administered daily for 5 consecutive days each week followed by 2 days without ridaforolimus and one 50 mg tablet of bicalutamide administered once daily for 7 days each week. Treatment will continue until disease progression.
• Drug: Comparator: Placebo
  • Four tablets of matching placebo to ridaforolimus administered daily for 5 consecutive days each week followed by 2 days without matching placebo and on 50 mg tablet of bicalutamide administered once daily for 7 days each week. Treatment will continue until disease progression.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • ridaforolimus (MK8669)+ bicalutamide
• Placebo Comparator: 2
  • Placebo + bicalutamide

Primary Measures

• 30% PSA decline within 12 weeks
  • Time Frame: 12 weeks
    Safety Issue?: No

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 10 ng/ml
• ECOG performance status less than or equal to 1

Exclusion Criteria:

• Previously received bicalutamide, flutamide, or nilutamide within the past 12 months
• 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

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Merck

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Overall Contact: Toll Free Number 1-888-577-8839 

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00777959

Study ID Number: 2008_572

ClinicalTrials.gov Identifier: NCT00777959

Health Authority: United States: Food and Drug Administration