Phase 1/2a Dose-Escalation and Expansion Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CORT125281 with Enzalutamide in Patients with Metastatic Castration-Resistant Prostate Cancer

Principal Investigator

Tomasz Beer

Study Purpose

The purpose of this study is to determine the side effects, good and/or bad, and the optimal recommended dose of an investigational drug called CORT125281 when given in combination with enzalutamide, a FDA approved hormone treatment for metastatic castration resistant prostate cancer, in participants with metastatic castration resistant prostate cancer.

Another purposes of the study is to measure the effects of the study drug, its mechanism of action on tumor cells and determine how the body processes and gets rid of the study drug.

Medical Condition(s)

Metastatic castration-resistant prostate cancer (mCRPC)

Eligibility Criteria

- Subjects should have metastatic castration-resistant prostate cancer
- Subjects should have recent disease progression during treatment with the FDA approved anti-androgen therapy (abiraterone or enzalutamide)
- Subjects should not have more than two previous treatment with cytotoxic chemotherapy in metastatic castration-resistant setting
- Subjects should not have any history of, or current brain metastases or conditions predisposing to seizure

Age Range

18 - NA

Healthy Volunteers Needed


Duration of Participation

Participants will receive the investigational drug and enzalutamide until their cancer gets worse or they experience unacceptable side effects. There will be one follow up visit 30 days after discontinuation of the study drugs. After discontinuation of the study drugs, participants will be contacted via a phone call every 4 months for at least two years.

Minors Included



Clinical Trials Information Line: Phone 503-494-1080 or


Corcept Therapeutics

Recruitment End


Compensation Provided


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