Last updated on December 2016

Study to Evaluate CORT125134 in Patients With Cushing's Syndrome


Brief description of study

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 Study Description

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.

Clinical Study Identifier: NCT02804750

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Kristi Balacy

Ft. Lauderdale, FL United States
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Kristi Balacy

Salford, United Kingdom
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