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Bicalutamide and Ridaforolimus in Men With Prostate Cancer
This study is ongoing, but not recruiting participants.
First Received: October 21, 2008   Last Updated: October 28, 2009   History of Changes
Sponsor: Merck
Collaborator: Ariad Pharmaceuticals
Information provided by: Merck
ClinicalTrials.gov Identifier: NCT00777959
  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
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:

Primary Outcome Measures:
  • 30% PSA decline within 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 156
Study Start Date: December 2008
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
ridaforolimus (MK8669)+ bicalutamide
Drug: ridaforolimus (MK8669)
Four 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.
2: Placebo Comparator
Placebo + bicalutamide
Drug: Comparator: Placebo
Four 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 10 ng/ml
  • ECOG performance status less than or equal to 1

Exclusion Criteria:

  • Previously received bicalutamide, flutamide, or nilutamide within the past 12 months
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00777959

  Show 18 Study Locations
Sponsors and Collaborators
Merck
Ariad Pharmaceuticals
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers: 2008_572, MK8669-002
Study First Received: October 21, 2008
Last Updated: October 28, 2009
ClinicalTrials.gov Identifier: NCT00777959     History of Changes
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 05, 2009