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

NCT ID: NCT00777959

Last Updated: 2015-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2011-06-30

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Open Label

ridaforolimus (MK8669)+ bicalutamide

Group Type: EXPERIMENTAL

open-label ridaforolimus (MK8669)

Intervention Type: DRUG

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

ridaforolimus (MK8669)+ bicalutamide

Group Type: EXPERIMENTAL

ridaforolimus (MK8669)

Intervention Type: DRUG

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 + bicalutamide

Group Type: PLACEBO_COMPARATOR

Comparator: Placebo

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

AP23573; AP23573

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Ariad Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Meulenbeld HJ, de Bono JS, Tagawa ST, Whang YE, Li X, Heath KH, Zandvliet AS, Ebbinghaus SW, Hudes GR, de Wit R. Tolerability, safety and pharmacokinetics of ridaforolimus in combination with bicalutamide in patients with asymptomatic, metastatic castration-resistant prostate cancer (CRPC). Cancer Chemother Pharmacol. 2013 Oct;72(4):909-16. doi: 10.1007/s00280-013-2250-6. Epub 2013 Aug 7.

Reference Type: RESULT

PMID: 23921574 (View on PubMed)

Other Identifiers

2008_572

Identifier Type: -

Identifier Source: secondary_id

8669-002

Identifier Type: -

Identifier Source: org_study_id