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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Metastatic Soft-Tissue Sarcomas, Metastatic Bone Sarcomas

Intervention / Treatment
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* Drug: ridaforolimus
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ridaforolimus<br> | Drug: ridaforolimus<br>* Four 10 mg tablets taken by mouth for 5 days per week continuously<br>* Other names: ridaforolimus was also known as deforolimus until May 2009;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Four 10 mg tablets taken by mouth for 5 days per week continuously<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival |  | Up to 157 weeks after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival: First Analysis |  | Up to 157 weeks after randomization | 
| Best Target Lesion Response (RECIST) |  | Up to 157 weeks after randomization | 
| Overall Survival: Updated Analysis as of 30 April 2011 |  | Up to 184 weeks after randomization | 
| Overall Survival: Updated Analysis as of 21 January 2012 |  | Up to 222 weeks after randomization | 
| Safety and tolerability |  | Up to 157 weeks after randomization |