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CompletedNCT00538239SUCCEEDUpdated Feb 13, 2015

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

A Phase 3 interventional study of ridaforolimus and Placebo in Metastatic Soft-Tissue Sarcomas and Metastatic Bone Sarcomas, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 13 Years and older. Per ClinicalTrials.gov, last updated 2015-02-13.

Sponsored by Merck Sharp & Dohme LLC · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
711
Allocation
Randomized
Ages
13 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Metastatic Soft-Tissue Sarcomas
  • Metastatic Bone Sarcomas
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In context

Sarcoma

1,667 studies on the registry are indexed under Sarcoma; 393 are open to participants now.

This study's enrollment of 711 is above the median of 40 across 1,283 interventional studies indexed under Sarcoma.

Browse Sarcoma studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,111 studies on the registry; 130 are open to participants now.

Of its 488 completed or terminated interventional studies of FDA-regulated products, 361 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
711 participants (actual)

Study arms

  • Experimental
    Ridaforolimus

    Drug: ridaforolimus

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • Drugridaforolimus

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

    Also known as: deforolimus, AP23573, MK-8669, ridaforolimus was also known as deforolimus until May 2009

  • DrugPlacebo

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

06

What researchers measure

Primary outcomes

  1. Progression-free Survival

    Time frame: Up to 157 weeks after randomization

Secondary outcomes

  1. Overall survival: First Analysis

    Time frame: Up to 157 weeks after randomization

  2. Best Target Lesion Response (RECIST)

    Time frame: Up to 157 weeks after randomization

  3. Overall Survival: Updated Analysis as of 30 April 2011

    Time frame: Up to 184 weeks after randomization

  4. Overall Survival: Updated Analysis as of 21 January 2012

    Time frame: Up to 222 weeks after randomization

  5. Safety and tolerability

    Time frame: Up to 157 weeks after randomization

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 23715582 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 13, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00538239
Lead sponsor
Merck Sharp & Dohme LLC
Collaborators
Ariad Pharmaceuticals
Responsible party
Sponsor
First posted
Oct 2, 2007
Start date
Oct 2007
Primary completion
Oct 2010
Completion
Dec 2012
Last update
Feb 13, 2015

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.

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