Onapristone and Anastrozole for the Treatment of Refractory Hormone Receptor Positive Endometrial Cancer

Completed · Phase 2

Conditions studied: Refractory Endometrial Adenocarcinoma, Refractory Endometrial Carcinoma, Refractory Endometrial Clear Cell Adenocarcinoma, Refractory Endometrial Endometrioid Adenocarcinoma, Refractory Endometrial Mixed Cell Adenocarcinoma, Refractory Endometrial Serous Adenocarcinoma, Refractory Endometrial Undifferentiated Carcinoma

In brief

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.

Key facts

Study ID

NCT04719273

Run by

Thomas Jefferson University

People needed

14

Starts

2021-01-28

Expected to finish

2025-12-17

Last updated by the study team

2026-07-17

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Age greater than or equal to 18 years old
• Histologically confirmed diagnosis of endometrial cancer with ER and/or PR expression >= 1% by IHC on archival tissue taken within the prior 3 years or new biopsy if no archival tissue is available. IHC results do not have to be from Thomas Jefferson University
• Patients who have failed one prior treatment with a platinum/taxane chemotherapy regimen for management of disease
• Patients cannot have treatment with more than 2 prior lines of therapy (one line must be platinum/taxane regimen)
• Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v.)1.1. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension. Each lesion must be >= 10 mm when measured by computed tomography (CT) or magnetic resonance imaging (MRI). Lymph nodes must be >= 15 mm in short axis when measured by CT or MRI
• Patients with the following histologic epithelial cell types are eligible:
• Endometrioid adenocarcinoma
• Serous adenocarcinoma
• Undifferentiated carcinoma
• Clear cell adenocarcinoma
• Mixed epithelial carcinoma
• Adenocarcinoma not otherwise specified (NOS)
• Please note: patients with carcinosarcoma are ineligible for this trial
• Patients must have had one prior treatment with a platinum/taxane chemotherapy regimen for management of disease
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Must have a life expectancy of at least 12 weeks as judged by the treating physician
• 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.
• Body weight > 30 kg
• Absolute neutrophil count 1500/ul or more
• Platelets 100,000/ul or more
• Hemoglobin 9 g/dl or more
• Bilirubin less than or equal to 1.5 x the upper limit of normal (except subjects with Gilbert syndrome, who can have total bilirubin < 3 mg/dl)
• Endocrine and targeted therapy protocols usually enroll patients with aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 2.5 x upper limit of normal (ULN) in patients without underlying liver metastasis and < 5.0 x ULN in patients with underlying liver metastasis

You may not qualify if…

• Concurrent or recent chemotherapy, radiotherapy, immunotherapy, or general anesthesia/major surgery within 3 weeks
• History of prior hormonal therapy (i.e., megestrol acetate, tamoxifen or aromatase inhibitors) for treatment cancer within the past 2 months. Other concurrent hormonal therapy will not be allowed on this trial
• Patient has a concurrent malignancy or history of invasive malignancy within 3 years of enrollment, with the exception of basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix that has completed curative therapy
• If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment
• Has received prior systemic anti-cancer therapy including investigational agents within 3 weeks prior to randomization
• Known brain metastasis which have not been treated or showed stability for >= 6 months
• Proteinuria > 1+ on urinalysis or > 1 gm/24 hours (hr)
• Known history of New York Heart Association stage 3 or 4 cardiac disease
• A pleural or pericardial effusion of greater than or equal to grade 3 severity
• Women who are pregnant or nursing
• Has an active infection requiring systemic therapy
• 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
• Patients may not be on a concurrent clinical trial, unless approved by investigator

Where it is running

• Jefferson Abington Hospital — Abington, Pennsylvania, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.