Phase 1-2 Study of Onapristone in Patients With Progesterone Receptor Expressing Cancers
Status:
Unknown status
Trial end date:
2016-04-01
Target enrollment:
Participant gender:
Summary
This is a multi-center, open-label, randomized, parallel group two-stage phase 1 study with a
phase 2 expansion component in pts with recurrent or metastatic APRpos uterine endometrioid
adenocarcinoma. Stage 1: Six dose cohorts, 5 using the extended release tablet (ER)
formulation (10 mg BID, 20 mg BID, 30 mg BID, 40 mg BID, 50 mg BID) and 1 using the
immediate-release (IR) tablet formulation 100 mg QD will be randomized in parallel. After
enrollment of 36 patients in Stage 1, a dose of 50 mg BID was determined to be the RP2D.
Stage 2: An additional 10 patients with recurrent or metastatic APRpos uterine endometrioid
adenocarcinoma (Stage 2a) will be enrolled at the RP2D. Based on the response in Stage 2a,
the cohort will be further expanded by up to 19 more patients to a total of 29 patients to
confirm the efficacy and safety profile of onapristone in this selected patient population
(Stage 2b).