Phase 2 Trial Evaluating the Combination of Apristor with Anastrazole for Women with Advanced Hormone Receptor Positive Endometrial Cancer

Trial Status:
Initiation of this Phase 2 study targeted for late 2019 or early 2020.

Program (Target):
Apristor (onapristone extended release) 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 Apristor has anticancer activity by inhibiting the binding of progesterone receptor to chromatin, downregulating cancer stem cell mobilization, and blocking immune evasion. Apristor is an investigational drug that has not been approved for marketing by any regulatory authority.

Disease Indication:
Advanced endometrial cancer.

Clinical Trial Description:
A prospective, Phase 2 single arm, multicenter study assessing the effect of Aromasin (anastrazole) in combination with Apristor in women with ER+, PR+ metastatic endometrial cancer after progression on at least one prior line of chemotherapy.

Mechanism of Action:

Progesterone receptor (PR) is enriched, referred to as “PR+”, in approximately 60% of endometrial cancer patients. PR enrichment and activation is driven by hormones (estrogen and progesterone) and MAPK-mediated post-translational modifications [1]. PR antagonists, including onapristone and mifepristone, have exhibited tumor modulation in preclinical models as well as human clinical trials [2,3].

Trial Sites:

City State Institution
Abington Pennsylvania Abington Memorial Hospital
Cherry Hill New Jersey Kennedy Health
Philadelphia Pennsylvania Sidney Kimmel Cancer Center at Jefferson Health

[1] Yang-Hartwich, Science Reports, 2014
[2] Rocereto, Gyn Oncology, 2000
[3] Cottu, Plos One, 2018