Clinical Trial of Ridaforolimus Compared to Progestin or Chemotherapy for Advanced Endometrial Carcinoma (8669-007)

Official Title

A Randomized Phase II Trial of Ridaforolimus (AP23573; MK-8669) Compared to Progestin or Chemotherapy in Female Adult Patients With Advanced Endometrial Carcinoma

Summary:

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.

Trial Description

Primary Outcome:

• Progression-free survival (PFS)

• The proportion of patients progression free at 16 weeks and 26 weeks, as assessed using modified RECIST guidelines.
• Overall Survival defined as the time from the date of randomization to the date of death
• Best target lesion response, defined as best change in sum of the target lesions from baseline to disease progression
• Safety and tolerability

View this trial on ClinicalTrials.gov