Window of Opportunity Trial of ONA-XR for PR+ Early Breast Cancer

Trial Status:
Enrollment in this Phase 2 study is completed.

Trial Titles:
Onward 203, ONAWA

For More Trial Information:
Please contact info@contextherapeutics.com or visit clinicaltrials.gov.

ClinicalTrials.gov Identifier:
NCT04142892 (Link)

Program (Target):
Onapristone extended release (ONA-XR) is a potent and specific antagonist of the progesterone receptor that is orally administered. Currently, there are no approved therapies that selectively target PR+ cancers. Preliminary preclinical and clinical data suggest that ONA-XR has anticancer activity by inhibiting the binding of progesterone receptor to chromatin, downregulating cancer stem cell mobilization, and blocking immune evasion.

Onapristone ER has not been approved for marketing by any regulatory authority.

Disease Indication:
Early stage breast cancer.

Clinical Trial Description:
A prospective, window of opportunity, single-arm, multicenter study assessing the effect of ONA-XR on breast cancer biology in women with early breast cancer.

Principal Investigators:

• Meritxell Bellet, MD, PhD

• Cristina Saura, MD, PhD

• Aleix Prat Aparicio, MD, PhD

Trial Sites: