Bicalutamide and Ridaforolimus in Men With Prostate Cancer - Tabular View

Tracking Information

First Received Date ^ICMJE

October 21, 2008

Last Updated Date

March 9, 2010

Start Date ^ICMJE

December 2008

Estimated Primary Completion Date

February 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

30% Prostate specific antigen (PSA) decline within 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Number of dose limiting toxicities (DLTs) [ Time Frame: Day 1 to Day 35 ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

30% PSA decline within 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00777959 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Prostate specific antigen (PSA) response rate [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Number of patients with progression free survival (PFS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Time to prostate specific antigen (PSA) progression [ Time Frame: 12 weeks ] [ Designated as 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 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Bicalutamide and Ridaforolimus in Men With Prostate Cancer

Official Title ^ICMJE

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

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 Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Allocation:  Randomized
Control:  Placebo Control
Endpoint Classification:  Safety/Efficacy Study
Intervention Model:  Parallel Assignment
Masking:  Double Blind (Subject, Investigator)
Primary Purpose:  Treatment

Condition ^ICMJE

Prostate Cancer

Intervention ^ICMJE

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 Name: AP23573
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.

Other Name: AP23573

Study Arms / Comparison Groups

Open Label: Experimental
ridaforolimus (MK8669)+ bicalutamide

Intervention: Drug: open-label ridaforolimus (MK8669)
Ridaforolimus: Experimental
ridaforolimus (MK8669)+ bicalutamide

Intervention: Drug: ridaforolimus (MK8669)
Placebo: Placebo Comparator
Placebo + bicalutamide

Intervention: Drug: Comparator: Placebo

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

156

Estimated Completion Date

February 2012

Estimated Primary Completion Date

February 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Male

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Toll Free Number

1-888-577-8839

Location Countries ^ICMJE

United States, Belgium, Colombia, Italy, Netherlands, Poland, Spain, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00777959

Responsible Party

Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp

Study ID Numbers ^ICMJE

2008_572, MK8669-002

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

Ariad Pharmaceuticals

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

March 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP