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| 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: Comparator: ridaforolimus (MK8669) Drug: Comparator: Placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| 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 |
| 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 |
|---|---|
|
1: Experimental
ridaforolimus (MK8669)+ bicalutamide
|
Drug: Comparator: 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.
|
|
2: 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.
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Toll Free Number | 1-888-577-8839 |
| 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 | |
| Study Director: | Medical Monitor | Merck |
More Information
| 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: | January 27, 2010 |
| ClinicalTrials.gov Identifier: | NCT00777959 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
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 |