Study to evaluate CORT125281 with Enzalutamide in patients with mCRPC

• Research type

  Research Study

• Full title

  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.

• IRAS ID

  235018

• Contact name

  Johann De Bono

• Contact email

  johann.de-bono@icr.ac.uk

• Sponsor organisation

  Corcept Therapeutics Incorporated

• Eudract number

  2017-003287-12

• Duration of Study in the UK

  3 years, 4 months, 30 days

• Research summary

  This is a first-in-man research study with the study medication CORT125281.This is an open-label study (the dose of the study medication given is known to the investigator and the patient) and the patient population will be patients with metastatic castration resistant prostate cancer (CRPC). It is designed to :
  * assess the safety and tolerability of CORT125281,
  * assess how the body handles the study medication (pharmacokinetics) and what effect the study medication has on the cancer (pharmacodynamics)
  * evaluate the preliminary efficacy of CORT125281 in combination with
  enzalutamide
  *to assess the impact of CORT125281 on enzalutamide exposure (drug-drug interactions),
  * assess the effect of food on CORT125281 pharmacokinetics.
  * identify the recommended dose for future studies.

  This study consists of 2 phases: a Dose Escalation Phase and an Expansion Phase. In each part of the study, routine assessments of safety and tolerability using adverse event monitoring measurement of vital signs, recording 12-lead electrocardiogram (ECG), physical examination and clinical laboratory safety tests, will be performed. Samples will be collected to determine standard PK parameters for CORT125281, enzalutamide, and their major metabolites.
  Approximately 40 patients will be enrolled in the Dose Escalation Phase. The number of patients will depend on the number of dose levels assessed and the DLTs observed. Approximately 40 patients will be enrolled in the Expansion Phase, 20 patients in each cohort. In the UK, 4 sites are anticipated to be involved in the study, with 30 patients anticipated to be enrolled in the study.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  17/LO/2032

• Date of REC Opinion

  8 Feb 2018

• REC opinion

  Further Information Favourable Opinion