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

August 18, 2015 updated by: Merck Sharp & Dohme LLC

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Open Label
ridaforolimus (MK8669)+ bicalutamide
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.
Other Names:
  • AP23573
Experimental: Ridaforolimus
ridaforolimus (MK8669)+ bicalutamide
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.
Other Names:
  • AP23573
Placebo Comparator: Placebo
Placebo + bicalutamide
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Prostate specific antigen (PSA) response rate
Time Frame: 12 weeks
12 weeks
Number of patients with progression free survival (PFS)
Time Frame: 12 weeks
12 weeks
Time to prostate specific antigen (PSA) progression
Time Frame: 12 weeks
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
30 Minutes to 24 hour postdose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Collaborators

Ariad Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

October 21, 2008

First Submitted That Met QC Criteria

October 21, 2008

First Posted (Estimate)

October 22, 2008

Study Record Updates

Last Update Posted (Estimate)

August 19, 2015

Last Update Submitted That Met QC Criteria

August 18, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8669-002
  • 2008_572

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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