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Antiprogestin

Onapristone ER + Anastrozole for Gynecologic Cancers

Phase 2
Waitlist Available
Led By Rachel Grisham, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Measurable disease as defined by RECIST 1.1, with at least one lesion that can be accurately measured in at least one dimension (each lesion must be ≥10mm when measured by CT or MRI, and lymph nodes must be ≥15mm in short axis when measured by CT or MRI)
Must be ≥ 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 36 weeks
Awards & highlights

Study Summary

This trial is testing the effects of a new drug, onapristone ER, alone and in combination with another drug, anastrozole.

Who is the study for?
This trial is for women over 18 with certain gynecologic cancers (like ovarian or endometrial cancer) that respond to progesterone. Participants must have recovered from previous treatments, have a Karnofsky Performance Status of at least 70%, and not be pregnant. They should also meet specific blood, kidney, and liver function criteria and agree to use contraception during the study.Check my eligibility
What is being tested?
The trial is testing the effects of Onapristone ER alone or combined with Anastrozole on patients with gynecologic cancers sensitive to progesterone. It aims to determine both positive outcomes and any adverse effects associated with these treatments.See study design
What are the potential side effects?
While the side effects are not explicitly listed in this summary, drugs like Onapristone ER can typically cause symptoms such as nausea, fatigue, hormonal imbalances, potential liver issues, while Anastrozole may lead to joint pain and hot flashes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a tumor or lymph node that meets the size requirements for measurement.
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I am 18 years old or older.
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I am able to care for myself but may not be able to do active work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 36 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 36 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
response rate

Trial Design

4Treatment groups
Experimental Treatment
Group I: PR+ Low grade serous ovarian cancerExperimental Treatment1 Intervention
Enrolled patients will initiate treatment with onapristone ER 50 mg by mouth twice daily, about 12 hours apart, beginning Day 1 of Cycle 1. A Cycle is 28 days
Group II: PR+ Granulosa cell tumor (This Arm is CLOSED)Experimental Treatment1 Intervention
Enrolled patients will initiate treatment with onapristone ER 50 mg by mouth twice daily, about 12 hours apart, beginning Day 1 of Cycle 1. A Cycle is 28 days. This Arm is CLOSED.
Group III: PR+ Granulosa cell ovarian cancerExperimental Treatment1 Intervention
Enrolled patients will initiate treatment with onapristone ER 50 mg by mouth twice daily, about 12 hours apart and anastrozole 1mg po QD in AM beginning Day 1 of Cycle 1. A Cycle is 28 days.
Group IV: PR+ Endometrioid endometrial cancerExperimental Treatment1 Intervention
Enrolled patients will initiate treatment with onapristone ER 50 mg by mouth twice daily, about 12 hours apart, beginning Day 1 of Cycle 1. A Cycle is 28 days

Find a Location

Who is running the clinical trial?

Context TherapeuticsIndustry Sponsor
2 Previous Clinical Trials
11 Total Patients Enrolled
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,586 Total Patients Enrolled
73 Trials studying Ovarian Cancer
42,968 Patients Enrolled for Ovarian Cancer
Context Therapeutics Inc.Industry Sponsor
4 Previous Clinical Trials
92 Total Patients Enrolled

Media Library

Onapristone ER (Antiprogestin) Clinical Trial Eligibility Overview. Trial Name: NCT03909152 — Phase 2
Ovarian Cancer Research Study Groups: PR+ Low grade serous ovarian cancer, PR+ Granulosa cell tumor (This Arm is CLOSED), PR+ Endometrioid endometrial cancer, PR+ Granulosa cell ovarian cancer
Ovarian Cancer Clinical Trial 2023: Onapristone ER Highlights & Side Effects. Trial Name: NCT03909152 — Phase 2
Onapristone ER (Antiprogestin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03909152 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What prior research exists concerning the efficacy of Onapristone ER?

"At this moment, there are 75 trials actively studying the efficacy of Onapristone ER. Out of these studies, 25 are in Phase 3 and 7821 clinic sites across the world are involved with research on Onapristone ER; particularly in Pisa, PI."

Answered by AI

What indications is Onapristone ER typically employed to treat?

"Onapristone ER is an effective therapeutic option for patients with malignant neoplasms in the breast and those whose hormone receptor status is unknown."

Answered by AI

Has the FDA greenlit Onapristone ER for clinical use?

"The safety of Onapristone ER was evaluated by the Power team and given a rating of 2. This is due to this being a Phase 2 trial, providing limited evidence in terms of efficacy but some data pertaining to its safety profile."

Answered by AI

Are there any North American medical institutes conducting this experiment?

"This medical study is open to patient enrollment at 8 different sites, including Memorial Sloan Kettering Basking Ridge in Basking Ridge, Memorial Sloan Kettering Bergen in Montvale and the flagship location of Memorial Sloan-Kettering Cancer Center located in New york. Additionally, there are 5 other places participating as well."

Answered by AI

How many participants are being recruited for this research?

"Affirmative. According to clinicaltrials.gov, the study is still actively seeking participants who are willing to enroll in this trial since its initial post on May 2nd 2019 and most recent update on September 19th 2022. 43 patients need to be enrolled from 8 different medical centres."

Answered by AI

Is recruitment underway for this experiment?

"Indeed, the information posted on clinicaltrials.gov indicates that this medical trial is actively recruiting participants. The study was initially made available to prospective patients on May 2nd 2019 and its protocols have been recently modified as of September 19th 2022. 43 individuals need to be enrolled from 8 different sites in order for data collection to begin."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of Onapristone ER Alone Or In Combination With Anastrozole in Gynecologic Cancers That Respond to Progesterone
2019. "A Study of Onapristone ER Alone Or In Combination With Anastrozole in Gynecologic Cancers That Respond to Progesterone". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03909152.
~6 spots leftby Apr 2025
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