CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 34 enrolled
Drug / intervention
Onapristone ER +1 moredrug
Likely dose
Onapristone ER 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03909152
NCT03909152Phase 2Completed
CompareCT.gov

Basket Study of the Oral Progesterone Antagonist Onapristone ER (Apristor), Alone or In Combination With Anastrozole in Women With Progesterone Receptor Positive (PR+) Recurrent Granulosa Cell Tumor, Low Grade Serous Ovarian Cancer or Endometrioid Endometrial Cancer

Memorial Sloan Kettering Cancer Center·interventional·Posted Apr 9, 2019·Updated Jul 28, 2025

In Brief

A Phase 2 clinical trial evaluating Onapristone ER and Onapristone ER + Anastrozole for Granulosa Cell Ovarian Cancer and 2 related conditions. Completed, enrolled 34 participants across 8 sites.

Detailed Summary

The purpose of this study is to test any good and bad effect of the study drug, onapristone extended-release (ER) alone and in combination with anastrozole.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGranulosa Cell Ovarian Cancer, Low Grade Serous Ovarian/ Primary Peritoneal Cancer, Endometrioid Endometrial Cancer
CountriesUnited States
CollaboratorsContext Therapeutics Inc.

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedApr 9, 2019
Enrollment StartMay 2, 2019
Primary CompletionSep 3, 2024
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 7.2 years ago

Interventions

Onapristone ERdrug

50 mg PO BID (with dosage adjustments) until POD, unacceptable toxicity or withdrawal of consent.

Onapristone ER + Anastrozoledrug

Onapristone ER Patients will take 50 PO BID in the form of two 20 mg tablets and one 10 mg tablet taken with food and water twice daily. Patients will be prescribed anastrozole 1mg PO QD. Anastrozole will be taken once daily in the AM with patients morning dose of onapristone ER.