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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
ridaforolimus (MK8669)
Comparator: Placebo
open-label ridaforolimus (MK8669)
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    Open Label

    Ridaforolimus

    Placebo

    Arm Description

    ridaforolimus (MK8669)+ bicalutamide

    ridaforolimus (MK8669)+ bicalutamide

    Placebo + bicalutamide

    Outcomes

    Primary Outcome Measures

    30% Prostate specific antigen (PSA) decline within 12 weeks
    Number of dose limiting toxicities (DLTs)

    Secondary Outcome Measures

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

    Full Information

    First Posted
    October 21, 2008
    Last Updated
    August 18, 2015
    Sponsor
    Merck Sharp & Dohme LLC
    Collaborators
    Ariad Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00777959
    Brief Title
    Bicalutamide and Ridaforolimus in Men With Prostate Cancer (MK-8669-002)
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2008 (undefined)
    Primary Completion Date
    May 2011 (Actual)
    Study Completion Date
    June 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC
    Collaborators
    Ariad Pharmaceuticals

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prostate Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    22 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Open Label
    Arm Type
    Experimental
    Arm Description
    ridaforolimus (MK8669)+ bicalutamide
    Arm Title
    Ridaforolimus
    Arm Type
    Experimental
    Arm Description
    ridaforolimus (MK8669)+ bicalutamide
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo + bicalutamide
    Intervention Type
    Drug
    Intervention Name(s)
    ridaforolimus (MK8669)
    Other Intervention Name(s)
    AP23573
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: Placebo
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    open-label ridaforolimus (MK8669)
    Other Intervention Name(s)
    AP23573
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    30% Prostate specific antigen (PSA) decline within 12 weeks
    Time Frame
    12 weeks
    Title
    Number of dose limiting toxicities (DLTs)
    Time Frame
    Day 1 to Day 35
    Secondary Outcome Measure Information:
    Title
    Prostate specific antigen (PSA) response rate
    Time Frame
    12 weeks
    Title
    Number of patients with progression free survival (PFS)
    Time Frame
    12 weeks
    Title
    Time to prostate specific antigen (PSA) progression
    Time Frame
    12 weeks
    Title
    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

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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 Patient has pain related to prostate cancer that warrants the initiation of chemotherapy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23921574
    Citation
    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 castration-resistant prostate cancer (CRPC). Cancer Chemother Pharmacol. 2013 Oct;72(4):909-16. doi: 10.1007/s00280-013-2250-6. Epub 2013 Aug 7.
    Results Reference
    result

    Learn more about this trial

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

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