drugset / Trial / NCT01936363

Trial of Pimasertib With SAR245409 or Placebo in Ovarian Cancer

NCT01936363

Phase 2 Completed 65 enrolled EMD Serono Sanofi · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a double blind, randomized, placebo-controlled, 2-arm, Phase 2 trial investigating the efficacy and safety of combination therapy of pimasertib plus SAR245409 and pimasertib placebo administered once per day compared to pimasertib administered twice per day plus SAR245409 placebo administered once per day in participants with previously treated unresectable low-grade serous ovarian or peritoneal carcinoma or serous borderline ovarian or peritoneal tumors.

Timeline

Start
2013-09-30
Primary completion
2015-05-31
Completion
2017-11-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Pimasertib Small molecule 60 mg Oral
Subject voxtalisib Small molecule 70 mg Oral

Indications