Conditions: Endometrial Neoplasms
Keywords: uterine neoplasms endometrial uterine cancer PI3K mTOR PI3K/mTOR recurrent metastatic
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 67
Healthy volunteers: no

Brief summary:
This study will investigate the individual safety and efficacy of two dual PI3K/mTOR inhibitors in patients with recurrent endometrial cancer.

Detailed description:
The study was prematurely discontinued due to lack confidence in the Stathmin assay as a patient selection criteria and subsequent lack of confidence in the efficacy signal that was observed. The decision to terminate the study was made on January 23, 2014. It should be noted that safety concerns have not been seen in this study and have not factored into this decision.

Arms:
arm 1: PI3K Basal, IV Compound arm 2: PI3K Activated, Oral Compound arm 3: Japanese lead in cohort, IV compound

Interventions: intervention 1: PF-05212384 intervention 2: PF-05212384 intervention 3: PF-05212384
Intervention descriptions: intervention 1: 154mg IV weekly intervention 2: 154mg IV weekly intervention 3: 154mg IV weekly

Protocol document: