Clinical trial NCT00538239: Ridaforolimus in Treatment of Sarcoma-SUCCEED (Sarcoma Multi-Center Clinical Evaluation of the Efficacy of Ridaforolimus)(8669-011 AM6)
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Metastatic Soft-Tissue Sarcomas
Metastatic Bone Sarcomas
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: Ariad Pharmaceuticals
First posted: 2007-10-02
Enrollment: 711
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Progression-free Survival
timeFrame: Up to 157 weeks after randomization
Secondary outcomes:
measure: Overall survival: First Analysis
timeFrame: Up to 157 weeks after randomization
measure: Best Target Lesion Response (RECIST)
timeFrame: Up to 157 weeks after randomization
measure: Overall Survival: Updated Analysis as of 30 April 2011
timeFrame: Up to 184 weeks after randomization
measure: Overall Survival: Updated Analysis as of 21 January 2012
timeFrame: Up to 222 weeks after randomization
measure: Safety and tolerability
timeFrame: Up to 157 weeks after randomization
Other outcomes:
Locations:
Study officials:
References:
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.