Cushing's Syndrome Clinical Trial
Official title:
Phase 2 Study of the Safety and Efficacy of CORT125134 in the Treatment of Endogenous Cushing's Syndrome
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, were not eligible for enrollment in this
study.
The purpose of this study was to evaluate the safety and efficacy of CORT125134 for treatment
of endogenous Cushing's syndrome. The multicenter study was conducted in the United States
and in Europe.
This was 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 was administered orally once daily for 16 weeks
with dose escalations occurring every 4 weeks.
Pharmacokinetics (PK) profiles were generated at every dose level. A data review committee
reviewed PK and safety data and recommended the final plan for dose escalation in Group 2.
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