NCT04719273

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

A Phase II Clinical Trial Evaluating the Combination of Onapristone With Anastrozole for Women With Refractory Hormone Receptor Positive Endometrial Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Thomas Jefferson University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVE: I. To evaluate the activity and safety of a pure progesterone receptor (PR) antagonist, extended-release onapristone (onapristone), with anastrozole to treat women with recurrent metastatic estrogen receptor positive (ER+)/progesterone receptor positive (PR+) endometrial carcinoma. SECONDARY OBJECTIVES: I. To estimate the disease control rate (DCR). II. To describe duration of response (DOR). III. To evaluate the safety and tolerability. IV. To evaluate quality of life using the Edmonton Symptom Assessment questionnaire. EXPLORATORY OBJECTIVES: I. To characterize the ER and PR expression by immunohistochemistry (IHC) pre- and post-treatment. OUTLINE: Patients receive onapristone orally (PO) twice daily (BID) and anastrozole PO once daily (QD) on days 1-28. Treatment repeats every 28 days for up to 24 cycles (24 months) in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for up to 1 year after last treatment administration.

Conditions

• 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

Interventions

Type	Name	Description
DRUG	Extended-release Onapristone	Given PO
DRUG	Anastrozole	Given PO
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies
DIAGNOSTIC_TEST	Estrogen Receptor Positive (Positive Estrogen Receptor; ESR Positive; ESR1 Positive; ER Positive; Estrogen Receptor Alpha Positive)	Immunohistochemistry (IHC):Integral : Tissue
DIAGNOSTIC_TEST	Progesterone Receptor Positive ( PGR Positive; PR Positive)	Immunohistochemistry (IHC)

Timeline

• Start date: 2021-01-28
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2021-01-22
• Last updated: 2025-01-08

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study