Last updated on June 2018

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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Clinical Study Lead

Pecs, Hungary

Clinical Study Lead

Salford, United Kingdom

Clinical Study Lead

Aurora, CO United States

Clinical Study Lead

Fort Lauderdale, FL United States

Clinical Study Lead

Miami, FL United States

Clinical Study Lead

Indianapolis, IN United States

Clinical Study Lead

Rochester, MN United States

Clinical Study Lead

Pittsburgh, PA United States

Clinical Study Lead

Richmond, VA United States

Clinical Study Lead

Seattle, WA United States

Clinical Study Lead

Budapest, Hungary

Clinical Study Lead

Cuneo, Italy

Clinical Study Lead

Messina, Italy

Clinical Study Lead

Milano, Italy

Clinical Study Lead

Naples, Italy

Clinical Study Lead

Orbassano, Italy

Clinical Study Lead

Roma, Italy

Clinical Study Lead

Siena, Italy

Clinical Study Lead

Torino, Italy

Clinical Study Lead

Leiden, Netherlands

Clinical Study Lead

Rotterdam, Netherlands