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

Study Overview
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Brief Summary
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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
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Ridaforolimus (MK8669/AP23573) was also known as deforolimus until May 2009.

Official Title
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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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: ridaforolimus (MK8669)
* Drug: Comparator: Placebo
* Drug: open-label ridaforolimus (MK8669)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open Label<br>ridaforolimus (MK8669)+ bicalutamide | Drug: open-label ridaforolimus (MK8669)<br>* 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.<br>* Other names: AP23573;|
| Experimental: Ridaforolimus<br>ridaforolimus (MK8669)+ bicalutamide | Drug: ridaforolimus (MK8669)<br>* 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.<br>* Other names: AP23573;|
| Placebo Comparator: Placebo<br>Placebo + bicalutamide | Drug: Comparator: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30% Prostate specific antigen (PSA) decline within 12 weeks |  | 12 weeks | 
| Number of dose limiting toxicities (DLTs) |  | Day 1 to Day 35 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prostate specific antigen (PSA) response rate |  | 12 weeks | 
| Number of patients with progression free survival (PFS) |  | 12 weeks | 
| Time to prostate specific antigen (PSA) progression |  | 12 weeks | 
| Pharmacokinetics Maximum Concentration (Cmax), Time to Maximum Plasma Concentration (Tmax), Area Under the Concentration Versus Time Curve (AUC) of Ridaforolimus |  | 30 Minutes to 24 hour postdose |