An Endometrial Cancer Study for Women With Recurrent or Persistent Endometrial Cancer

Summary

This is an open-label, multi-center, single-arm, two-period Phase 2 study. The study will investigate the efficacy of Sodium Cridanimod in conjunction with progestin therapy in a population of subjects with recurrent or persistent endometrial cancer, who have failed progestin monotherapy or who have been identified as Progesterone Receptor (PrR) negative. All patients must have endometrial cancer PrR status determined from an archival sample at Screening. The PrR status (positive or negative) will be determined by central laboratory by ImmunoHistoChemistry (IHC) testing. There are two treatment periods and a follow-up period within the study.

Timeline

Start

2017-06-14

Primary completion

2020-07-17

Completion

2020-07-17

Outcome

Outcome not reported

Stopped (Business): “The study was discontinued due to a change in development strategy and not due safety concern.”

Drugs

Indications