Clinical Trial: Study to Evaluate CORT125134 in Patients With Cushing's Syndrome
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Phase 2 Study of the Safety and Efficacy of CORT125134 in the Treatment of Endogenous Cushing's Syndrome
Brief Summary:
Cushing's syndrome is a relatively rare disorder caused by prolonged exposure to high levels of the glucocorticoid hormone cortisol. Cushing's syndrome may result from elevated endogenous or exogenous sources of cortisol. Endogenous Cushing's syndrome resulting from cortisol overproduction by the adrenal glands is the subject of this protocol.
Patients with exogenous Cushing's syndrome, which develops as a side effect of chronic administration of high doses of glucocorticoids, are not eligible for enrollment in this study.
The purpose of this study is to evaluate the safety and efficacy of CORT125134 for treatment of endogenous Cushing's syndrome. The multicenter study will be conducted in the United States and in Europe.
Detailed Summary:
This is a Phase 2, open-label study with two dose groups, each with a two-step dose escalation, designed to evaluate the safety and efficacy of CORT125134 for the treatment of endogenous Cushing's syndrome. CORT125134 will be administered orally once daily for 12 weeks with dose escalations occuring every 4 weeks.
PK profiles will be generated at every dose level. A data review committee will review PK and safety data and will recommend the final plan for dose escalation in Group 2.
Sponsor: Corcept Therapeutics
Current Primary Outcome: General safety of CORT125134 in patients with endogenous Cushing's syndrome. [ Time Frame: 12 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome: The evidence of reduction in cortisol activity following treatment of CORT125134 in patients with endogenous Cushing's syndrome. [ Time Frame: 12 months ]
Original Secondary Outcome: Same as current
Information By: Corcept Therapeutics
Dates:
Date Received: June 15, 2016
Date Started: June 2016
Date Completion: December 2017
Last Updated: April 10, 2017
Last Verified: April 2017