Study to Evaluate CORT125134 in Patients With 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, 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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Phase 2 Study of the Safety and Efficacy of CORT125134 in the Treatment of Endogenous Cushing's Syndrome|
- General safety of CORT125134 in patients with endogenous Cushing's syndrome. [ Time Frame: 12 months ]The safety profile of CORT125134 in patients with Cushing's syndrome as assessed by physical examination findings, vital signs, ECG results, clinical laboratory tests, adverse events (CTCAE v4.0) and concomitant medications.
- The evidence of reduction in cortisol activity following treatment of CORT125134 in patients with endogenous Cushing's syndrome. [ Time Frame: 12 months ]The reduction in cortisol activity following treatment with CORT125134 in patients with endogenous Cushing's syndrome based on improvement in glucose control and/or blood pressure.
|Study Start Date:||June 2016|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
Group 1: 100 mg/day for 4 weeks, then 150 mg/day for 4 weeks, then 200 mg/day for 4 weeks.
Group 2: 250 mg/day for 4 weeks, then 300 mg/day for 4 weeks, then 350 mg/day for 4 weeks.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02804750
|Contact: Clinical Study Leadfirstname.lastname@example.org|
|United States, Colorado|
|Aurora, Colorado, United States, 80045|
|United States, Florida|
|Fort Lauderdale, Florida, United States, 33312|
|Miami, Florida, United States, 33136|
|United States, Indiana|
|Indianapolis, Indiana, United States, 46202|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|United States, Pennsylvania|
|Pittsburgh, Pennsylvania, United States, 15212|
|United States, Virginia|
|Richmond, Virginia, United States, 23119|
|United States, Washington|
|Seattle, Washington, United States, 98122|
|Salford, Manchester, United Kingdom|
|Study Director:||Andreas G Moraitis, MD||Corcept Therapeutics|