The purpose of this study is to assess the efficacy of ridaforolimus when administered once daily for 5 consecutive days (QDx5) every two weeks in participants with advanced sarcoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
216
12.5 mg of ridaforolimus is given intravenously over 30 minutes once daily for 5 days, every 2 weeks
Number of participants with Clinical Benefit Response (CBR) Using Response Criteria in Solid Tumors (RECIST)
Time frame: Day 1 up to 4 years or discontinuation from study
Time to Tumor Progression
Time frame: Day 1 up to the first observation of disease progression, death, or the date of the last evaluation of response (up to 4 years)
Progression Free Survival
Time frame: Day 1 to the first observation of disease progression, death, or the date of the last evaluation of response (up to 4 years)
Overall Survival
Time frame: Day 1 to the date of death, or the date of last contact (up to 4 years)
Duration of Response
Time frame: Day 1 up to the first observation of disease progression, death, or the date of the last evaluation of response (up to 4 years)
Number of participants experiencing adverse events
Time frame: From first dose up to 30 days after last dose (up to 1 year)
Number of participants who discontinued study drug due to adverse events
Time frame: From first dose up to the last dose (up to 1 year)
Mean ridaforolimus blood levels within 5 minutes post intravenous infusion
Time frame: Day 1 and Day 5 of Cycle 1
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