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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

Must not have

Refractory nausea and vomiting, requirement for parenteral hydration and/or nutrition, drainage gastrostomy tube, malabsorption, external biliary shunt, or significant small bowel resection that would preclude adequate study drug absorption

Use of any prescription medication during the prior 28 days of first onapristone dosing that the investigator judges is likely to interfere with onapristone activity; specifically strong inhibitors or inducers, or sensitive substrates of cytochrome P450 CYP3A4 (Investigators should consult the following table of clinically-relevant products)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 36 weeks

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe nausea or vomiting, need IV fluids or feeding, have a drainage tube, or had significant intestine surgery affecting medication absorption.

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I haven't taken any medication in the last 28 days that could affect my treatment.

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I have been on corticosteroids in the last 28 days and need to continue them.

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I have not had any cancer other than non-melanoma skin cancer or fully treated in situ carcinoma in the last 3 years.

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I have not had a heart attack or severe heart issues in the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 36 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

response rate

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Onapristone ER

2019

Completed Phase 2

~40

Onapristone ER + Anastrozole

2019

Completed Phase 2

~40