The purpose of this study is to compare progression-free survival (PFS) of patients with advanced, recurrent or metastatic endometrial cancer who have received one, but not more than two, prior lines of chemotherapy either as adjuvant therapy or treatment for advanced disease, and then when treated with ridaforolimus or the investigators' choice of progestin or chemotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
130
40 mg once daily oral tablets for 5 days followed by 2 days without ridaforolimus
oral medroxyprogesterone acetate tablets 200 mg daily OR oral megestrol acetate tablets 40 mg 4 times per day (160 mg daily)
Chemotherapy - carboplatin, paclitaxel, doxorubicin, pegylated liposomal doxorubicin or topotecan administered as a single agent or as a doublet, and will be administered at doses and schedules chosen by the investigator
Progression-free survival (PFS)
Time frame: From randomization up to 30 months
The proportion of patients progression free at 16 weeks as assessed using modified RECIST guidelines.
Time frame: From randomization to Week 16
The proportion of patients progression free at 26 weeks as assessed using modified RECIST guidelines
Time frame: From randomization to Week 26
Overall survival
Time frame: From randomization up to 30 months
Best target lesion response, defined as best change in sum of the target lesions from baseline to disease progression
Time frame: From randomization up to 30 months
Safety and tolerability
Time frame: From randomization up to 30 days after discontinuation of treatment
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