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

Merck Sharp & Dohme LLC0 sites22 target enrollmentOctober 2008

ConditionsProstate Cancer

Interventionsopen-label ridaforolimus (MK8669)ridaforolimus (MK8669)

Drugsridaforolimus (MK8669)Comparator: Placebo open-label ridaforolimus (MK8669)

Overview

Phase: Phase 2
Intervention: open-label ridaforolimus (MK8669)
Conditions: Prostate Cancer
Sponsor: Merck Sharp & Dohme LLC
Enrollment: 22
Primary Endpoint: Number of dose limiting toxicities (DLTs)
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2008

End Date

June 2011

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Merck Sharp & Dohme LLC

Responsible Party

Sponsor

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

Exclusion Criteria

Not provided

Arms & Interventions

Open Label

ridaforolimus (MK8669)+ bicalutamide

Intervention: open-label ridaforolimus (MK8669)

Ridaforolimus

ridaforolimus (MK8669)+ bicalutamide

Intervention: ridaforolimus (MK8669)

Outcomes

Primary Outcomes

Number of dose limiting toxicities (DLTs)

Time Frame: Day 1 to Day 35

30% Prostate specific antigen (PSA) decline within 12 weeks

Time Frame: 12 weeks

Secondary Outcomes

Pharmacokinetics Maximum Concentration (Cmax), Time to Maximum Plasma Concentration (Tmax), Area Under the Concentration Versus Time Curve (AUC) of Ridaforolimus(30 Minutes to 24 hour postdose)
Number of patients with progression free survival (PFS)(12 weeks)
Prostate specific antigen (PSA) response rate(12 weeks)
Time to prostate specific antigen (PSA) progression(12 weeks)