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

This study has been completed.
Sponsor:
Collaborator:
Ariad Pharmaceuticals
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00538239
First received: September 28, 2007
Last updated: March 13, 2014
Last verified: March 2014

September 28, 2007
March 13, 2014
October 2007
October 2010   (final data collection date for primary outcome measure)
Progression-free Survival [ Time Frame: Up to 157 weeks after randomization ] [ Designated as safety issue: No ]
Progression-free Survival
Complete list of historical versions of study NCT00538239 on ClinicalTrials.gov Archive Site
  • Overall survival: First Analysis [ Time Frame: Up to 157 weeks after randomization ] [ Designated as safety issue: No ]
  • Best Target Lesion Response (RECIST) [ Time Frame: Up to 157 weeks after randomization ] [ Designated as safety issue: No ]
  • Overall Survival: Updated Analysis as of 30 April 2011 [ Time Frame: Up to 184 weeks after randomization ] [ Designated as safety issue: No ]
  • Overall Survival: Updated Analysis as of 21 January 2012 [ Time Frame: Up to 222 weeks after randomization ] [ Designated as safety issue: No ]
  • Safety and tolerability [ Time Frame: Up to 157 weeks after randomization ] [ Designated as safety issue: Yes ]
Overall survival, antitumor response, change in cancer-related symptoms, safety, and tolerability.
Not Provided
Not Provided
 
Ridaforolimus in Treatment of Sarcoma-SUCCEED (Sarcoma Multi-Center Clinical Evaluation of the Efficacy of Ridaforolimus)(8669-011 AM6)
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Metastatic Soft-Tissue Sarcomas
  • Metastatic Bone Sarcomas
  • 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
  • Drug: Placebo
    Four 10 mg tablets taken by mouth for 5 days per week continuously
  • Experimental: Ridaforolimus
    Intervention: Drug: ridaforolimus
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
711
December 2012
October 2010   (final data collection date for primary outcome measure)

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
Both
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00538239
8669-011, AP23573-07-302
Yes
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Ariad Pharmaceuticals
Not Provided
Merck Sharp & Dohme Corp.
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP