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A Study of Onapristone ER Alone Or In Combination With Anastrozole in Gynecologic Cancers That Respond to Progesterone

NCT03909152 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2025-07-28

Study results available
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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.

Conditions

  • Granulosa Cell Ovarian Cancer
  • Low Grade Serous Ovarian/ Primary Peritoneal Cancer
  • Endometrioid Endometrial Cancer

Interventions

DRUG

Onapristone ER

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

DRUG

Onapristone ER + Anastrozole

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.

Sponsors & Collaborators

Principal Investigators

  • Rachel Grisham, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-02
Primary Completion
2024-09-03
Completion
2024-09-03
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03909152 on ClinicalTrials.gov