Onapristone for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
University of Wisconsin Carbone Cancer Center, Madison, WIBreast Cancer+2 MoreOnapristone - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug to see if it works well with another existing drug to treat metastatic breast cancer.

Eligible Conditions
  • Estrogen Receptor-positive Breast Cancer
  • HER2-negative Breast Cancer
  • Metastatic Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

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1
Onapristone ER
1
OP-1250 with Ribociclib
1
Talazoparib

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: up to 3 years

up to 2 years
Objective Response Rate (ORR)
up to 3 years
Disease Control Rate (DCR)
Duration of Response
Incidence of Adverse Events
Progression Free Survival (PFS) Rate
Time to Response

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Onapristone ER
1
OP-1250 with Ribociclib
1
Talazoparib

Trial Design

1 Treatment Group

Onapristone In Combination with Fulvestrant
1 of 1

Experimental Treatment

39 Total Participants · 1 Treatment Group

Primary Treatment: Onapristone · No Placebo Group · Phase 2

Onapristone In Combination with FulvestrantExperimental Group · 2 Interventions: Onapristone, Fulvestrant · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Onapristone
Not yet FDA approved
Fulvestrant
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 years

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor
1,081 Previous Clinical Trials
2,591,933 Total Patients Enrolled
33 Trials studying Breast Cancer
38,453 Patients Enrolled for Breast Cancer
Context Therapeutics Inc.Industry Sponsor
4 Previous Clinical Trials
154 Total Patients Enrolled
1 Trials studying Breast Cancer
67 Patients Enrolled for Breast Cancer
Context TherapeuticsIndustry Sponsor
2 Previous Clinical Trials
62 Total Patients Enrolled
Kari B Wisinski, MDPrincipal InvestigatorUniversity of Wisconsin, Madison
2 Previous Clinical Trials
22 Total Patients Enrolled
Sailaja Kamaraju, MD, MSStudy ChairMedical College of Wisconsin

Eligibility Criteria

Age 18+ · All Participants · 23 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Rewritten Criterion: You can still participate in the study if you have received other standard treatments for your condition, such as mTOR inhibitors.
References

Frequently Asked Questions

Is this medical trial actively seeking participants?

"Clinicaltrials.gov's records indicate that this clinical trial is currently in search of candidates, after having been published on October 5th 2021 and last revised on July 7th 2022." - Anonymous Online Contributor

Unverified Answer

What medicinal purposes does Onapristone typically serve?

"Endocrine therapy, breast cancer, and certain diseases can all be managed using onapristone." - Anonymous Online Contributor

Unverified Answer

What other empirical research has been conducted using Onapristone?

"Presently, there are 136 active clinical trials surveying the impacts of Onapristone with 32 studies in their final stage. While some trails for this drug may be found in Shanghai, a total of 5812 locations across the world have opened up opportunities to participate in these research projects." - Anonymous Online Contributor

Unverified Answer

How many individuals are actively involved in this research trial?

"Affirmative. Information posted on clinicaltrials.gov reveals that this research project is in the process of recruiting patients, initially published on October 5th 2021 and most recently updated July 7th 2022. A total of 39 participants are needed from 2 medical centres." - Anonymous Online Contributor

Unverified Answer

Has Onapristone been granted authorization by the FDA?

"Considering the Phase 2 status of this trial, our team at Power assigned Onapristone a score of 2 for safety. This indicates that there is evidence supporting its security but no clinical data has been provided in regards to efficacy." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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