Ridaforolimus in Treatment of Sarcoma-SUCCEED (Sarcoma Multi-Center Clinical Evaluation of the Efficacy of Ridaforolimus)(8669-011 AM6)

Merck Sharp & Dohme LLC (Industry)
Overall Status
CT.gov ID
Ariad Pharmaceuticals (Industry)

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether maintenance therapy with oral AP23573 (ridaforolimus), by preventing and controlling tumor growth for a prolonged period of time in patients with metastatic soft-tissue or bone sarcomas responding to chemotherapy, will result in clinically significant improvement in progression-free survival as compared to oral placebo.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Actual Enrollment :
711 participants
Intervention Model:
Parallel Assignment
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Official Title:
A Pivotal Trial to Determine the Efficacy and Safety of AP23573 When Administered as Maintenance Therapy to Patients With Metastatic Soft-Tissue or Bone Sarcomas
Study Start Date :
Oct 1, 2007
Actual Primary Completion Date :
Oct 1, 2010
Actual Study Completion Date :
Dec 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ridaforolimus

Drug: ridaforolimus
Four 10 mg tablets taken by mouth for 5 days per week continuously
Other Names:
  • deforolimus
  • AP23573
  • MK-8669
  • ridaforolimus was also known as deforolimus until May 2009
  • Placebo Comparator: Placebo

    Drug: Placebo
    Four 10 mg tablets taken by mouth for 5 days per week continuously

    Outcome Measures

    Primary Outcome Measures

    1. Progression-free Survival [Up to 157 weeks after randomization]

    Secondary Outcome Measures

    1. Overall survival: First Analysis [Up to 157 weeks after randomization]

    2. Best Target Lesion Response (RECIST) [Up to 157 weeks after randomization]

    3. Overall Survival: Updated Analysis as of 30 April 2011 [Up to 184 weeks after randomization]

    4. Overall Survival: Updated Analysis as of 21 January 2012 [Up to 222 weeks after randomization]

    5. Safety and tolerability [Up to 157 weeks after randomization]

    Eligibility Criteria


    Ages Eligible for Study:
    13 Years and Older
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:
    Inclusion Criteria:
    • Confirmed diagnosis of metastatic soft-tissue or bone sarcoma

    • Ongoing complete response, partial response, or stable disease (RECIST) after a minimum of 4 cycles (and maximum of 12 months) of any one first, second, or third line of prior cytotoxic chemotherapy for metastatic disease

    • Eastern Cooperative Oncology Group performance status of 0 or 1

    • Adequate organ and bone marrow function

    • Completed prior chemotherapy with last dose received at least 3 and up to 12 weeks prior to randomization

    Exclusion Criteria:
    • Prior therapy with rapamycin or rapamycin analogs

    • Ongoing toxicity associated with prior anticancer therapy

    • Another primary malignancy within the past three years

    • Concomitant medications that induce or inhibit CYP3A

    • Significant, uncontrolled cardiovascular disease

    Contacts and Locations


    No locations specified.

    Sponsors and Collaborators

    • Merck Sharp & Dohme LLC
    • Ariad Pharmaceuticals


    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information


    None provided.
    Responsible Party:
    Merck Sharp & Dohme LLC
    ClinicalTrials.gov Identifier:
    Other Study ID Numbers:
    • 8669-011
    • AP23573-07-302
    First Posted:
    Oct 2, 2007
    Last Update Posted:
    Feb 13, 2015
    Last Verified:
    Feb 1, 2015
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 13, 2015