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Hormone Therapy

Onapristone ER for Breast Cancer

Phase 1

Waitlist Available

Led By Komal Jhaveri, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial is testing the safety of a new drug for people with metastatic or unresectable ER+/PR+/HER2- breast cancer. Researchers will test different doses of the drug to find the safest dose with the fewest side effects.

Eligible Conditions

Metastatic Breast Cancer
Breast Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

recommended phase 2 dose (RP2D) of onapristone ER

Trial Design

1Treatment groups

Experimental Treatment

Group I: Letrozole, Palbociclib, and Onapristone ERExperimental Treatment3 Interventions

This study has two stages: a dose-finding stage and a dose expansion stage. Stage 1 of the study will utilize a standard 3+3 dose de-escalation design with a total of three dose levels of onapristone ER, 30mg PO BID, 40mg PO BID, and 50mg PO BID given on a 28-day cycle. Onapristone ER will be given in addition to letrozole 2.5mg QD and each patient's pre-enrollment dose of palbociclib.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Letrozole

FDA approved

Palbociclib

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Context TherapeuticsIndustry Sponsor

2 Previous Clinical Trials

45 Total Patients Enrolled

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,934 Previous Clinical Trials

588,810 Total Patients Enrolled

203 Trials studying Breast Cancer

81,137 Patients Enrolled for Breast Cancer

Context Therapeutics Inc.Industry Sponsor

4 Previous Clinical Trials

126 Total Patients Enrolled

1 Trials studying Breast Cancer

67 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many sites are conducting this research initiative?

"At present, 7 locations are hosting this clinical trial. These include Montvale, Middletown and Harrison amongst others. To reduce the need for long-distance travel, participants should consider selecting a site close to their home address."

Answered by AI

Is Onapristone ER known to cause adverse effects in patients?

"Based on the limited data regarding Onapristone ER's safety and efficacy, our score for this medication is a 1."

Answered by AI

What indications is Onapristone ER popularly prescribed for?

"Onapristone ER is typically prescribed as a malignant neoplasms treatment. However, it can also be utilized to manage advanced hr + her2 - breast cancer, prior endocrine therapy, and anovulatory cycle cases."

Answered by AI

What is the maximum capacity of participants for this scientific research?

"Affirmative. Clinicaltrials.gov substantiates that this medical investigation is presently seeking participants, having been initially posted on September 9th 2021 and recently modified on the 12th of September 2022. Altogether, 28 patients are needed to be enrolled across 7 distinct treatment locations."

Answered by AI

Are there still opportunities for participants to join this experiment?

"The trial is currently enlisting participants, as indicated on clinicaltrials.gov. This research project was initially posted on September 9th 2021 and most recently updated three days ago, on the 12th of September 2022."

Answered by AI

Have researchers conducted any prior investigations into Onapristone ER?

"Currently, there are 256 research initiatives for Onapristone ER in progress with 48 studies at Phase 3. Although most of the trials occur in Burgas, New jersey, 15103 sites worldwide are conducting investigations into Onapristone ER's therapeutic potential."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "A Study of Letrozole, Palbociclib, and Onapristone ER in People With Metastatic Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04872608.