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

NCT04719273 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2025-01-08

No results posted yet for this study

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.

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

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)

Sponsors & Collaborators

  • Context Therapeutics Inc.

    collaborator INDUSTRY

  • Thomas Jefferson University

    lead OTHER

Principal Investigators

  • Tommy Buchanan, MD · Thomas Jefferson University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-28
Primary Completion
2025-12-31
Completion
2025-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04719273 on ClinicalTrials.gov