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

Phase 2

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: ridaforolimus (MK8669); Drug: open-label ridaforolimus (MK8669)

• Registration Number: NCT00777959
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-10-21
• Study First Submitted QC: 2008-10-21
• Study First Posted: 2008-10-22
• Primary Completion: 2011-05
• Study Completion: 2011-06
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-18
• Last Update Posted: 2015-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 22

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 Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ridaforolimus	ridaforolimus (MK8669)	ridaforolimus (MK8669)+ bicalutamide
Open Label	open-label ridaforolimus (MK8669)	ridaforolimus (MK8669)+ bicalutamide

Primary Outcome Measures

Name	Time	Method
Number of dose limiting toxicities (DLTs)	Day 1 to Day 35
30% Prostate specific antigen (PSA) decline within 12 weeks	12 weeks

Secondary Outcome Measures

Name	Time	Method
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
Prostate specific antigen (PSA) response rate	12 weeks
Time to prostate specific antigen (PSA) progression	12 weeks
Number of patients with progression free survival (PFS)	12 weeks