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

This study has been completed.
Sponsor:
Collaborator:
Ariad Pharmaceuticals
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00777959
First received: October 21, 2008
Last updated: March 7, 2014
Last verified: March 2014
  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 2

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:


Further study details as provided by Merck Sharp & Dohme Corp.:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00777959

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Ariad Pharmaceuticals
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00777959     History of Changes
Other Study ID Numbers: 8669-002, 2008_572
Study First Received: October 21, 2008
Last Updated: March 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Bicalutamide
Sirolimus
Androgen Antagonists
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014