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

Enrollment:	22
Study Start Date:	December 2008
Study Completion Date:	May 2011
Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 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 Name: 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.

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

Sponsors and Collaborators

Merck

Ariad Pharmaceuticals

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Vice President of Late Stage Development, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00777959 History of Changes
Other Study ID Numbers:	2008_572, MK8669-002
Study First Received:	October 21, 2008
Last Updated:	June 29, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Bicalutamide
Sirolimus
Androgen Antagonists
Hormone Antagonists

Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antibiotics, Antineoplastic
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on February 12, 2012