Onapristone

DRUG6 trials

Sponsors

Arno Therapeutics, SOLTI Breast Cancer Research Group, University of Wisconsin, Madison, Context Therapeutics Inc.

Conditions

Androgen-independent Prostate CancerBreast CancerER-positive Breast CancerHER2-negative Breast CancerMetastatic CancerMetastatic Prostate CancerProgesterone Receptor Positive Tumor: Max 1 Line of Prior Chemotherapy, no Prior Hormone TherapyProstate Cancer

Early Phase 1

Onapristone as Preoperative Treatment for Postmenopausal Women With Hormone Receptor + and HER2- Breast Cancer

CompletedNCT04142892

SOLTI Breast Cancer Research GroupBreast Cancer

Start: 2020-11-06End: 2021-04-30Updated: 2022-04-01

Phase 1

Phase 1-2 Study of Onapristone in Patients With Advanced Castration-resistant Prostate Cancer

Arno TherapeuticsAndrogen-independent Prostate Cancer, Metastatic Prostate Cancer, Prostate Cancer +1

Start: 2014-02-28End: 2017-12-31Target: 75Updated: 2015-06-24

Phase 1-2 Study of Onapristone in Patients With Progesterone Receptor Expressing Cancers

Arno TherapeuticsProgesterone Receptor Positive Tumor: Max 1 Line of Prior Chemotherapy, no Prior Hormone Therapy

Start: 2014-01-31End: 2016-04-30Target: 60Updated: 2015-06-24

Study of Elacestrant in Combination With Onapristone in Patients With Advanced or Metastatic Breast Cancer

TerminatedNCT05618613

Context Therapeutics Inc.Breast Cancer

Start: 2022-12-02End: 2023-06-23Updated: 2026-07-21

A Rollover Protocol of Elacestrant, in Combination With Onapristone, for Patients With ER+, PR+, HER2- Advanced or Metastatic Breast Cancer

WithdrawnNCT06938711

Context Therapeutics Inc.Breast Cancer

Start: 2023-06-30End: 2023-12-31Updated: 2025-04-22

Phase 2

Onapristone and Fulvestrant for ER+ HER2- Metastatic Breast Cancer After Endocrine Therapy and CDK4/6 Inhibitors (The SMILE Study)

TerminatedNCT04738292

University of Wisconsin, MadisonER-positive Breast Cancer, HER2-negative Breast Cancer, Metastatic Cancer

Start: 2021-10-05End: 2023-05-15Updated: 2024-05-03

Related Papers

Preoperative onapristone-XR in postmenopausal women with progesterone receptor-positive (PgR+)/HER2-negative early breast cancer: SOLTI-1802 ONAWA trial results

npj Breast Cancer2026-05-29

Abstract P1-07-02: Primary results of ONAWA (SOLTI-1802) trial: A window of opportunity trial of onapristone in postmenopausal women with progesterone receptor-positive/HER2-negative early breast cancer (EBC)

Cancer Research2022-02-153 citations

Abstract OT2-16-01: The SMILE study: A phase 2 trial of onapristone in combination with fulvestrant for patients with ER+ and HER2- metastatic breast cancer after progression on endocrine therapy and CDK4/6 inhibitors

Cancer Research2022-02-15

Phase I study of onapristone, a type I antiprogestin, in female patients with previously treated recurrent or metastatic progesterone receptor-expressing cancers.

2018-10-1018 citations

Phase 1-2 study of progesterone receptor (PR) inhibition with extended-release (ER) onapristone (ONA) alone or in combination with abiraterone (AA) in patients (pts) with castration-resistant prostate cancer (CRPC) incorporating plasma DNA analysis to define androgen receptor (AR) status.

Journal of Clinical Oncology2017-05-201 citations

Validation of a population pharmacokinetic (PPK) model for onapristone (ONA) in patients (pts) with cancer: Analysis of 2 clinical trials.

Journal of Clinical Oncology2016-05-20

Abstract 4512: Onapristone in patients (pts) with progesterone receptor (PR)-expressing cancers: PK results from part 1 of a randomized, parallel-dose phase 1 study

Cancer Research2015-08-01

Onapristone (ONA) in progesterone receptor (PR)-expressing tumors: Efficacy and biomarker results of a dose-escalation phase 1 study.

Journal of Clinical Oncology2015-05-203 citations

Phase 1-2 study of progesterone receptor (PR) inhibition with extended-release (ER) onapristone (ONA) in patients (pts) with castration-resistant prostate cancer (CRPC): PK, safety and PR testing results from the dose escalation cohort.

Journal of Clinical Oncology2015-05-201 citations

Safety and pharmacokinetic (PK) results from phase 1 of an ongoing phase 1-2 study of onapristone (ONA) in patients (pts) with progesterone receptor (PR)-expressing cancers.

Journal of Clinical Oncology2015-05-20

Phase 2 clinical study of onapristone (ONA) in patients (pts) with uterine endometrioid adenocarcinoma (EC) expressing the activated progesterone receptor (APR<sup>pos</sup>).

Journal of Clinical Oncology2015-05-20

A phase 1-2 study of the type I progesterone receptor (PR) antagonist onapristone (ONA) in patients (pts) with advanced castration-resistant prostate cancer (CRPC).

Journal of Clinical Oncology2014-05-203 citations

A randomized, parallel-dose phase 1 study of onapristone (ONA) in patients (pts) with progesterone receptor (PR)-expressing cancers.

Journal of Clinical Oncology2014-05-202 citations