Study on Onapristone and Anastrozole for Treating Resistant Hormone Receptor Positive Endometrial Cancer

Sponsor: Thomas Jefferson University

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04719273

Provider View

This clinical trial is exploring the effects of combining two drugs, onapristone and anastrozole, to treat endometrial cancer that has not responded to previous treatments. These drugs work by blocking hormones that help cancer cells grow.

Patient Parameters

Program Overview

This study is testing whether a combination of two drugs, onapristone and anastrozole, can help treat endometrial cancer that has not responded to other treatments. Endometrial cancer cells can grow due to hormones like progesterone and estrogen. Onapristone blocks progesterone, while anastrozole reduces estrogen production. The study aims to see if using both drugs together is more effective than using anastrozole alone.

Description

The main goal of this study is to see how well onapristone, a drug that blocks progesterone, works with anastrozole, a drug that reduces estrogen, in treating women with recurring or spreading endometrial cancer that is positive for estrogen and progesterone receptors.

Secondary goals include measuring how long the treatment controls the disease, how long the response lasts, and evaluating the safety and side effects of the treatment. The study will also assess the quality of life of participants using a specific questionnaire.

Participants will take onapristone twice a day and anastrozole once a day in 28-day cycles, continuing for up to 24 cycles (or 24 months) unless the cancer progresses or side effects become unacceptable. After finishing the treatment, participants will have follow-up visits every three months for up to a year.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of endometrial cancer with hormone receptors (ER and/or PR) present in at least 1% of cancer cells.
  • Have previously received one treatment with platinum/taxane chemotherapy for the cancer.
  • Have measurable cancer that can be tracked using scans.
  • Have specific types of endometrial cancer, such as endometrioid adenocarcinoma or serous adenocarcinoma.
  • Be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have a life expectancy of at least 12 weeks.
  • Be postmenopausal, either naturally or through surgery.
  • Weigh more than 30 kg.
  • Have adequate blood cell counts and organ function as determined by specific tests.
  • Be able to understand and sign a consent form.
  • Have recovered from any previous cancer treatments.
  • Be able to swallow tablets whole.
  • Be able to read and speak English.

Exclusion Criteria

  • Have had recent chemotherapy, radiotherapy, or major surgery within the last 3 weeks.
  • Have used hormonal therapy for cancer treatment in the past 2 months.
  • Have another active cancer or a history of invasive cancer within the last 3 years, except for certain skin cancers or cervical cancer that has been treated.
  • Have untreated or unstable brain metastases.
  • Have significant protein in the urine or severe heart disease.
  • Have a large fluid buildup around the lungs or heart.
  • Be pregnant or breastfeeding.
  • Have an active infection requiring treatment.
  • Be taking medications that could interfere with onapristone.
  • Be participating in another clinical trial without approval.

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