Study to Evaluate Exicorilant (CORT125281) in Combination With Enzalutamide in Patients With Metastatic Castration-Resistant Prostate Cancer

Summary

This study consists of a dose escalation study with an expansion phase to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD), and preliminary efficacy of exicorilant (CORT125281) in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC) to identify a recommended dose (RD) for Phase 2 studies.

Timeline

Start

2018-02-20

Primary completion

2021-10-13

Completion

2023-01-12

Outcome

Missed primary endpoint

Stopped (Enrollment): “The level of benefit observed did not justify enrolling patients in the Dose Expansion phase of the study.”

paper Enzalutamide combined with mifepristone was safe and well tolerated but did not meet its primary endpoint. PMID 35110415 ↗

Publications

• Serritella AV, Shevrin D, Heath EI, Wade JL, Martinez E, Anderson A, Schonhoft J, Chu YL, Karrison T, Stadler WM, Szmulewitz RZ. Phase I/II Trial of Enzalutamide and Mifepristone, a Glucocorticoid Receptor Antagonist, for Metastatic Castration-Resistant Prostate Cancer. Clin Cancer Res. 2022 Apr 14;28(8):1549-1559. doi: 10.1158/1078-0432.CCR-21-4049.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Enzalutamide	Other / unclassified	—	Oral
Subject	Exicorilant	Small molecule	140 mg	Oral
Subject	Exicorilant	Small molecule	180 mg	Oral
Subject	Exicorilant	Small molecule	240 mg	Oral
Subject	Exicorilant	Small molecule	280 mg	Oral
Subject	Exicorilant	Small molecule	320 mg	Oral

Indications