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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
711
Four 10 mg tablets taken by mouth for 5 days per week continuously
Four 10 mg tablets taken by mouth for 5 days per week continuously
Progression-free Survival
Time frame: Up to 157 weeks after randomization
Overall survival: First Analysis
Time frame: Up to 157 weeks after randomization
Best Target Lesion Response (RECIST)
Time frame: Up to 157 weeks after randomization
Overall Survival: Updated Analysis as of 30 April 2011
Time frame: Up to 184 weeks after randomization
Overall Survival: Updated Analysis as of 21 January 2012
Time frame: Up to 222 weeks after randomization
Safety and tolerability
Time frame: Up to 157 weeks after randomization
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