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

NCT06938711 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: ONA-XR-104
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This is a rollover study for patients enrolled in the discontinued ELONA clinical trial (ONA-XR-103) with the primary objective to characterize the safety of elacestrant in combination with onapristone either alone or in combination.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Characterize the safety of elacestrant in combination with onapristone.

  Monitor the treatment-related adverse events as assessed by CTCAE v4.0

  7 months

Study Arms (1)

Elacestrant / Onapristone

EXPERIMENTAL

Elacestrant and Onapristone combination

Drug: Elacestrant; Drug: Onapristone

Interventions

Elacestrant DRUG

Elacestrant 200mg once daily oral dosing in cycles of 28 days.

Also known as: RAD1901

Elacestrant / Onapristone

Onapristone DRUG

Onapristone 40mg twice daily oral dosing in cycles of 28 days.

Elacestrant / Onapristone

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is currently enrolled in the ELONA clinical study (ONA-XR-103) and receiving onapristone or elacestrant, either alone or in combination.
• Patient is currently benefiting from the treatment in the ELONA clinical study, as determined by the investigator.
• Patient currently has no evidence of progressive disease, as determined by the investigator.

You may not qualify if:

• Pregnant or nursing (lactating) women.
• Female patients of childbearing potential (e.g., are menstruating) who do not agree to abstinence or, if sexually active, do not agree to the use of highly effective contraception, throughout the study and for up to 30 days after stopping study treatment.

Sponsors & Collaborators

• Context Therapeutics Inc.: lead

Study Sites (1)

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

elacestrant; RAD1901; onapristone

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: April 22, 2025
• Study Start: June 1, 2023
• Primary Completion: November 1, 2023
• Study Completion: December 1, 2023
• Last Updated: April 22, 2025

Record last verified: 2025-04

Locations

US (1)