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

Merck Sharp & Dohme LLC22 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Prostate Cancer

Interventions

ridaforolimus (MK8669)DRUG

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.

Comparator: PlaceboDRUG

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.

open-label ridaforolimus (MK8669)DRUG

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.

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

30% Prostate specific antigen (PSA) decline within 12 weeks

Time frame: 12 weeks

Number of dose limiting toxicities (DLTs)

Time frame: Day 1 to Day 35

Secondary Outcomes

Prostate specific antigen (PSA) response rate

Time frame: 12 weeks

Number of patients with progression free survival (PFS)

Time frame: 12 weeks

Time to prostate specific antigen (PSA) progression

Time frame: 12 weeks

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

Data from ClinicalTrials.gov

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