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Onapristone

Generic Name
Onapristone
Drug Type
Small Molecule
Chemical Formula
C29H39NO3
CAS Number
96346-61-1
Unique Ingredient Identifier
H6H7G23O3N
Background

Onapristone has been used in trials studying the treatment of Prostate Cancer, Recurrent Prostate Cancer, Metastatic Prostate Cancer, Androgen-independent Prostate Cancer, and Progesterone Receptor Positive Tumor: Max 1 Line of Prior Chemotherapy, no Prior Hormone Therapy.

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

Phase 1
Withdrawn
Conditions
Breast Cancer
Interventions
First Posted Date
2025-04-22
Last Posted Date
2025-04-22
Lead Sponsor
Context Therapeutics Inc.
Registration Number
NCT06938711
Locations
๐Ÿ‡บ๐Ÿ‡ธ

Sarah Cannon Research Institute, Nashville, Tennessee, United States

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

Phase 1
Terminated
Conditions
Breast Cancer
Interventions
First Posted Date
2022-11-16
Last Posted Date
2025-05-09
Lead Sponsor
Context Therapeutics Inc.
Target Recruit Count
4
Registration Number
NCT05618613
Locations
๐Ÿ‡บ๐Ÿ‡ธ

Cancer Treatment Centers of America - Western Regional Medical Center, Phoenix, Arizona, United States

๐Ÿ‡บ๐Ÿ‡ธ

Sarah Cannon Research Institute, Nashville, Tennessee, United States

๐Ÿ‡บ๐Ÿ‡ธ

Cancer Treatment Centers of America - Midwestern Regional Center, Zion, Illinois, United States

A Study of Letrozole, Palbociclib, and Onapristone ER in People With Metastatic Breast Cancer

Phase 1
Withdrawn
Conditions
Metastatic Breast Cancer
Unresectable Breast Cancer
Interventions
First Posted Date
2021-05-04
Last Posted Date
2023-04-28
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Registration Number
NCT04872608
Locations
๐Ÿ‡บ๐Ÿ‡ธ

Memorial Sloan Kettering Westchester (All Protocol Activities), Harrison, New York, United States

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

Phase 2
Terminated
Conditions
Metastatic Cancer
HER2-negative Breast Cancer
ER-positive Breast Cancer
Interventions
First Posted Date
2021-02-04
Last Posted Date
2024-05-03
Lead Sponsor
University of Wisconsin, Madison
Target Recruit Count
11
Registration Number
NCT04738292
Locations
๐Ÿ‡บ๐Ÿ‡ธ

University of Wisconsin Carbone Cancer Center, Madison, Wisconsin, United States

๐Ÿ‡บ๐Ÿ‡ธ

Medical College of Wisconsin, Milwaukee, Wisconsin, United States

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

Phase 2
Active, not recruiting
Conditions
Refractory Endometrial Adenocarcinoma
Refractory Endometrial Carcinoma
Refractory Endometrial Serous Adenocarcinoma
Refractory Endometrial Mixed Cell Adenocarcinoma
Refractory Endometrial Undifferentiated Carcinoma
Refractory Endometrial Clear Cell Adenocarcinoma
Refractory Endometrial Endometrioid Adenocarcinoma
Interventions
Other: Quality-of-Life Assessment
Other: Questionnaire Administration
Diagnostic Test: Estrogen Receptor Positive (Positive Estrogen Receptor; ESR Positive; ESR1 Positive; ER Positive; Estrogen Receptor Alpha Positive)
Diagnostic Test: Progesterone Receptor Positive ( PGR Positive; PR Positive)
First Posted Date
2021-01-22
Last Posted Date
2025-01-08
Lead Sponsor
Thomas Jefferson University
Target Recruit Count
14
Registration Number
NCT04719273
Locations
๐Ÿ‡บ๐Ÿ‡ธ

Jefferson Abington Hospital, Abington, Pennsylvania, United States

๐Ÿ‡บ๐Ÿ‡ธ

Thomas Jefferson University, Philadelphia, Pennsylvania, United States

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

Early Phase 1
Completed
Conditions
Breast Cancer
Interventions
First Posted Date
2019-10-29
Last Posted Date
2022-04-01
Lead Sponsor
SOLTI Breast Cancer Research Group
Target Recruit Count
10
Registration Number
NCT04142892
Locations
๐Ÿ‡ช๐Ÿ‡ธ

Hospital Clรญnic de Barcelona, Barcelona, Spain

๐Ÿ‡ช๐Ÿ‡ธ

Hospital Universitari Vall d'Hebron, Barcelona, Spain

๐Ÿ‡ช๐Ÿ‡ธ

Hospital Universitario Sant Joan de Reus, Tarragona, Spain

and more 1 locations

A Study of Onapristone ER Alone Or In Combination With Anastrozole in Gynecologic Cancers That Respond to Progesterone

Phase 2
Active, not recruiting
Conditions
Granulosa Cell Ovarian Cancer
Low Grade Serous Ovarian/ Primary Peritoneal Cancer
Endometrioid Endometrial Cancer
Interventions
First Posted Date
2019-04-09
Last Posted Date
2024-05-02
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Target Recruit Count
34
Registration Number
NCT03909152
Locations
๐Ÿ‡บ๐Ÿ‡ธ

Memorial Sloan Kettering Cancer Center, New York, New York, United States

๐Ÿ‡บ๐Ÿ‡ธ

Memorial Sloan Kettering Rockville Centre, Rockville Centre, New York, United States

๐Ÿ‡บ๐Ÿ‡ธ

Memorial Sloan Kettering Nassau, Uniondale, New York, United States

and more 5 locations

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

Phase 1
Conditions
Progesterone Receptor Positive Tumor: Max 1 Line of Prior Chemotherapy, no Prior Hormone Therapy
Interventions
First Posted Date
2014-01-31
Last Posted Date
2015-06-24
Lead Sponsor
Arno Therapeutics
Target Recruit Count
60
Registration Number
NCT02052128
Locations
๐Ÿ‡ซ๐Ÿ‡ท

Institut Curie Oncologie Medicale, Paris, France

๐Ÿ‡ซ๐Ÿ‡ท

Centre Oscar Lambret, Lille, France

๐Ÿ‡ซ๐Ÿ‡ท

Institut Gustave Roussy, Villejuif, France

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

Phase 1
Conditions
Prostate Cancer
Androgen-independent Prostate Cancer
Recurrent Prostate Cancer
Metastatic Prostate Cancer
Interventions
First Posted Date
2014-01-30
Last Posted Date
2015-06-24
Lead Sponsor
Arno Therapeutics
Target Recruit Count
75
Registration Number
NCT02049190
Locations
๐Ÿ‡ฌ๐Ÿ‡ง

Inst of Cancer Research & Royal Marsden NHS Foundation Trust, Sutton Surrey, United Kingdom

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