Onapristone + Anastrozole for Endometrial Cancer

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byRussell Schilder, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Thomas Jefferson University

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This phase II trial studies the effect of onapristone and anastrozole in treating patients with hormone receptor positive endometrial cancer that has not responded to previous treatment (refractory). Progesterone and estrogen are hormones that can cause the growth of endometrial cancer cells. Onapristone blocks the use of progesterone by the tumor cells. Anastrozole is a drug that blocks the production of estrogen in the body. Giving onapristone with anastrozole may work better than anastrozole alone in treating patients with hormone receptor positive endometrial cancer.

Eligibility Criteria

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.

Inclusion Criteria

I am fully active or can carry out light work.

I have fully recovered from my previous radiation treatments.

I am a woman who has gone through menopause.

+19 more

Exclusion Criteria

I have had cancer treatment, including trial drugs, within the last 3 weeks.

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

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

+10 more

Participant Groups

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.

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.

Anastrozole is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Arimidex for:

Breast cancer
Early breast cancer in postmenopausal women

🇺🇸 Approved in United States as Arimidex for:

Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer
First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer

🇨🇦 Approved in Canada as Arimidex for:

Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer
Treatment of postmenopausal women with hormone receptor-positive advanced breast cancer

🇯🇵 Approved in Japan as Arimidex for: