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

Primary Purpose

Metastatic Soft-Tissue Sarcomas, Metastatic Bone Sarcomas

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
ridaforolimus
Placebo
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Soft-Tissue Sarcomas

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Ridaforolimus

    Placebo

    Arm Description

    Outcomes

    Primary Outcome Measures

    Progression-free Survival

    Secondary Outcome Measures

    Overall survival: First Analysis
    Best Target Lesion Response (RECIST)
    Overall Survival: Updated Analysis as of 30 April 2011
    Overall Survival: Updated Analysis as of 21 January 2012
    Safety and tolerability

    Full Information

    First Posted
    September 28, 2007
    Last Updated
    February 12, 2015
    Sponsor
    Merck Sharp & Dohme LLC
    Collaborators
    Ariad Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00538239
    Brief Title
    Ridaforolimus in Treatment of Sarcoma-SUCCEED (Sarcoma Multi-Center Clinical Evaluation of the Efficacy of Ridaforolimus)(8669-011 AM6)
    Acronym
    SUCCEED
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2007 (undefined)
    Primary Completion Date
    October 2010 (Actual)
    Study Completion Date
    December 2012 (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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Metastatic Soft-Tissue Sarcomas, Metastatic Bone Sarcomas

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    711 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Ridaforolimus
    Arm Type
    Experimental
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    ridaforolimus
    Other Intervention Name(s)
    deforolimus, AP23573, MK-8669, ridaforolimus was also known as deforolimus until May 2009
    Intervention Description
    Four 10 mg tablets taken by mouth for 5 days per week continuously
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Four 10 mg tablets taken by mouth for 5 days per week continuously
    Primary Outcome Measure Information:
    Title
    Progression-free Survival
    Time Frame
    Up to 157 weeks after randomization
    Secondary Outcome Measure Information:
    Title
    Overall survival: First Analysis
    Time Frame
    Up to 157 weeks after randomization
    Title
    Best Target Lesion Response (RECIST)
    Time Frame
    Up to 157 weeks after randomization
    Title
    Overall Survival: Updated Analysis as of 30 April 2011
    Time Frame
    Up to 184 weeks after randomization
    Title
    Overall Survival: Updated Analysis as of 21 January 2012
    Time Frame
    Up to 222 weeks after randomization
    Title
    Safety and tolerability
    Time Frame
    Up to 157 weeks after randomization

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    13 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23715582
    Citation
    Demetri GD, Chawla SP, Ray-Coquard I, Le Cesne A, Staddon AP, Milhem MM, Penel N, Riedel RF, Bui-Nguyen B, Cranmer LD, Reichardt P, Bompas E, Alcindor T, Rushing D, Song Y, Lee RM, Ebbinghaus S, Eid JE, Loewy JW, Haluska FG, Dodion PF, Blay JY. Results of an international randomized phase III trial of the mammalian target of rapamycin inhibitor ridaforolimus versus placebo to control metastatic sarcomas in patients after benefit from prior chemotherapy. J Clin Oncol. 2013 Jul 1;31(19):2485-92. doi: 10.1200/JCO.2012.45.5766. Epub 2013 May 28.
    Results Reference
    result

    Learn more about this trial

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

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