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	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

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

Estimated Enrollment:	156
Study Start Date:	December 2008
Estimated Study Completion Date:	August 2012
Estimated Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental ridaforolimus (MK8669)+ bicalutamide	Drug: ridaforolimus (MK8669) Four 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 Four 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 10 ng/ml
ECOG performance status less than or equal to 1

Exclusion Criteria:

Previously received bicalutamide, flutamide, or nilutamide within the past 12 months
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

Show 18 Study Locations

Sponsors and Collaborators

Merck

Ariad Pharmaceuticals

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2008_572, MK8669-002
Study First Received:	October 21, 2008
Last Updated:	October 28, 2009
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 November 05, 2009