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Completed

NCT Number: NCT00777959

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

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

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ridaforolimus (MK8669)

Drug

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 names: AP23573

Comparator: placebo

Drug

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)

Drug

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 names: AP23573

Primary outcomes

  1. 30% Prostate specific antigen (PSA) decline within 12 weeks

    Time frame: 12 weeks

  2. Number of dose limiting toxicities (DLTs)

    Time frame: Day 1 to Day 35

Secondary outcomes

  1. Prostate specific antigen (PSA) response rate

    Time frame: 12 weeks

  2. Number of patients with progression free survival (PFS)

    Time frame: 12 weeks

  3. Time to prostate specific antigen (PSA) progression

    Time frame: 12 weeks

  4. 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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Collaborators

  • Ariad Pharmaceuticals

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Oct 22, 2008
Registry last updated
Aug 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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