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: February 2012

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

Intervention(s) in this Clinical Trial

• Drug: ridaforolimus (MK8669)
  • Three 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
  • Three 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.
• Drug: open-label ridaforolimus (MK8669)
  • Single dose of three 10 mg tablets ridaforolimus on Day 1, and 50 mg bicalutamide once daily starting on Day 2. On Day 8, patients will begin taking three 10 mg tablets of ridaforolimus daily for 5 consecutive days each week followed by 2 days without ridaforolimus and one 50 mg tablet of bicalutamide once daily for 7 days each week. Treatment will continue until disease progression.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Open Label
  • ridaforolimus (MK8669)+ bicalutamide
• Experimental: Ridaforolimus
  • ridaforolimus (MK8669)+ bicalutamide
• Placebo Comparator: Placebo
  • Placebo + bicalutamide

Primary Measures

• 30% Prostate specific antigen (PSA) decline within 12 weeks
  • Time Frame: 12 weeks
    Safety Issue?: No
• Number of dose limiting toxicities (DLTs)
  • Time Frame: Day 1 to Day 35
    Safety Issue?: Yes

Secondary Measures

• Prostate specific antigen (PSA) response rate
  • Time Frame: 12 weeks
    Safety Issue?: No
• Number of patients with progression free survival (PFS)
  • Time Frame: 12 weeks
    Safety Issue?: No
• Time to prostate specific antigen (PSA) progression
  • Time Frame: 12 weeks
    Safety Issue?: No
• Pharmacokinetics Maximum Concentration (Cmax), Time to Maximum Plasma Concentration (Tmax), Area Under the Concentration Versus Time Curve (AUC) of Ridaforolimus
  • Time Frame: 30 Minutes to 24 hour postdose
    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 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

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 March 10, 2010

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