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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: ridaforolimus (MK8669); Drug: open-label ridaforolimus (MK8669); Drug: Comparator: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00777959

8669-002

2008_572

Details and patient eligibility

About

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

Full description

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

Enrollment: 22 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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22 participants in 3 patient groups, including a placebo group

Open Label

Experimental group

Description:

ridaforolimus (MK8669)+ bicalutamide

Treatment:

Drug: open-label ridaforolimus (MK8669)

Ridaforolimus

Experimental group

Description:

ridaforolimus (MK8669)+ bicalutamide

Treatment:

Drug: ridaforolimus (MK8669)

Placebo

Placebo Comparator group

Description:

Placebo + bicalutamide

Treatment:

Drug: Comparator: Placebo