Bicalutamide and Ridaforolimus in Men With Prostate Cancer - Full Text View

Sponsor:	Merck
Collaborator:	Ariad Pharmaceuticals
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00777959

Purpose

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

Condition	Intervention	Phase
Prostate Cancer	Drug: ridaforolimus (MK8669) Drug: Comparator: Placebo Drug: open-label ridaforolimus (MK8669)	Phase II

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Bicalutamide AP 23573

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	156
Study Start Date:	December 2008
Estimated Study Completion Date:	February 2012
Estimated Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Open Label: Experimental 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.
Ridaforolimus: Experimental 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.
Placebo: Placebo Comparator 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.

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00777959

Contacts

Contact: Toll Free Number

1-888-577-8839

Locations

United States, Arizona
Call for Information	Recruiting
Sierra Vista, Arizona, United States, 85635
United States, Arkansas
Call for Information	Recruiting
Little Rock, Arkansas, United States, 72211
United States, California
Call for Information	Recruiting
Los Angeles, California, United States, 90095-1691
United States, Indiana
Call for Information	Recruiting
Jeffersonville, Indiana, United States, 47130
United States, Missouri
Call for Information	Recruiting
Saint Louis, Missouri, United States, 63110
United States, New Mexico
Call for Information	Recruiting
Albuquerque, New Mexico, United States, 87109
United States, New York
Call for Information	Recruiting
New York, New York, United States, 10065
United States, North Carolina
Call for Information	Recruiting
Chapel Hill, North Carolina, United States, 27599-7295
United States, Washington
Call for Information	Recruiting
Seattle, Washington, United States, 98111-0900
Call for Information	Recruiting
Seattle, Washington, United States, 98104
Belgium
Merck Sharp & Dohme B.V.	Recruiting
Bruxelles, Belgium, 1180
Contact: Nathalie Schrameijer 32-2-373-4310
Colombia, Cundinamarca
Frosst Laboratories Inc.	Recruiting
Bogota, Cundinamarca, Colombia
Contact: Felipe Arbelaez 57-1-592-4400
Italy
Merck Sharp & Dohme (Italia) S.P.A.	Recruiting
Roma, Italy, 191
Contact: Gianfranco Botta 39 06 36 191187
Netherlands
Merck Sharp & Dohme B.V.	Recruiting
Haarlem, Netherlands, 2031 BN
Contact: Caroline Doornebos 31-23-515-3362
Poland
MSD Polska Sp. z o.o. Dzial Medyczny	Recruiting
Warszawa, Poland, 00-867
Contact: Adam Czernik 48 22 549-51-39
Spain
Merck Sharp & Dohme De Espana, S.A.E.	Recruiting
Madrid, Spain, 28027
Contact: Jorge Gonzalez-Esteban 34-91-3210-728
United Kingdom, Hertfordshire
Merck Sharp & Dohme Ltd.	Recruiting
Hoddesdon, Hertfordshire, United Kingdom, EN11 9BU
Contact: Paul Robinson 44 1992 452396

Sponsors and Collaborators

Merck

Ariad Pharmaceuticals

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck Sharp & Dohme Corp ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2008_572, MK8669-002
Study First Received:	October 21, 2008
Last Updated:	March 9, 2010
ClinicalTrials.gov Identifier:	NCT00777959 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Sirolimus
Anti-Infective Agents
Immunologic Factors
Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Urogenital Neoplasms
Antibiotics, Antineoplastic

Genital Diseases, Male
Immunosuppressive Agents
Pharmacologic Actions
Anti-Bacterial Agents
Neoplasms
Androgen Antagonists
Neoplasms by Site
Antifungal Agents
Therapeutic Uses
Bicalutamide
Prostatic Neoplasms

ClinicalTrials.gov processed this record on March 18, 2010