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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00777959
• Other study ID #: 8669-002
• Secondary ID: 2008_572
• Status: Completed
• Phase: Phase 2
• First received: October 21, 2008
• Last updated: August 18, 2015
• Start date: October 2008
• Est. completion date: June 2011

Study information

• Verified date: August 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: June 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.	Ariad Pharmaceuticals

References & Publications (1)

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 castrati — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30% Prostate specific antigen (PSA) decline within 12 weeks		12 weeks	No
Primary	Number of dose limiting toxicities (DLTs)		Day 1 to Day 35	Yes
Secondary	Prostate specific antigen (PSA) response rate		12 weeks	No
Secondary	Number of patients with progression free survival (PFS)		12 weeks	No
Secondary	Time to prostate specific antigen (PSA) progression		12 weeks	No
Secondary	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	No