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Hormone Therapy

Onapristone + Anastrozole for Endometrial Cancer

Phase 2

Waitlist Available

Led By Russell Schilder, MD

Research Sponsored by Thomas Jefferson University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Females are only eligible for this study if they are postmenopausal. This is defined as meeting one of the following criteria: S/p total abdominal hysterectomy and bilateral salpingo-oopherectomy, Patients who are in menopause is defined clinically as 12 consecutive months of amenorrhea in a woman over 55 in the absence of other biological or physiological causes OR women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mL

Must not have

Concurrent or recent chemotherapy, radiotherapy, immunotherapy, or general anesthesia/major surgery within 3 weeks

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year post-treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a combination of drugs to treat endometrial cancer that hasn't responded to previous treatment. The drugs block hormones that can cause cancer cell growth.

Who is the study for?

This trial is for adults over 18 with hormone receptor positive endometrial cancer that hasn't improved after platinum/taxane chemotherapy. Participants must have tried no more than two treatments, be able to swallow pills, weigh over 30 kg, and have recovered from previous therapies. Women must be postmenopausal and not pregnant or nursing. People with certain heart conditions, untreated brain metastases, severe infections or recent major surgery are excluded.

What is being tested?

The trial tests onapristone combined with anastrozole against refractory hormone receptor positive endometrial cancer. Onapristone blocks progesterone use by tumor cells while anastrozole inhibits estrogen production in the body. The goal is to see if this combination works better than anastrozole alone.

What are the potential side effects?

Potential side effects may include hormonal imbalances leading to mood swings or hot flashes, gastrointestinal issues like nausea or diarrhea, fatigue due to low energy levels caused by the treatment's effect on hormones and possible liver function changes detectable through blood tests.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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I am a woman who has gone through menopause.

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My liver function tests are within the required range for my condition.

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My kidney function, measured by GFR, is adequate.

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I am 18 years old or older.

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I have had no more than 2 previous cancer treatments, including one with platinum/taxane.

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I have tried one platinum/taxane chemotherapy without success.

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My cancer is one of the specified types and not carcinosarcoma.

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I have a tumor or lymph node large enough to be measured by scans.

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I weigh more than 30 kilograms.

Exclusion Criteria

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

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I haven't had chemotherapy, radiotherapy, immunotherapy, or major surgery in the last 3 weeks.

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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 severe heart disease.

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I have a severe fluid buildup in my chest or around my heart.

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I am currently being treated for an infection.

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I have not taken hormonal cancer treatments like tamoxifen in the last 2 months.

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I am not pregnant or nursing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year post-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year post-treatment for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Objective response rate (ORR)

Progression-Free Survival (PFS)

Secondary study objectives

Disease Control Rate

Quality of Life and pain score

Type, frequency and severity of adverse events and laboratory abnormalities

Other study objectives

Estrogen receptor and progesterone receptor expression

Side effects data

From 2018 Phase 4 trial • 79 Patients • NCT02137538

10%

Fracture

Acne

Scoliosis

Hair loss

Sacroiliitis

Neuro event

100%

80%

60%

40%

20%

Study treatment Arm

Anastrozole

Letrozole

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (onapristone, anastrozole)Experimental Treatment6 Interventions

Patients receive onapristone PO BID and anastrozole PO QD on days 1-28. Treatment repeats every 28 days for up to 24 cycles (24 months) until November 30, 2023 or in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Anastrozole

2016

Completed Phase 4

~5550

0 / 17Eligibility criteria met