Study to Evaluate CORT125134 in Participants With Cushing's Syndrome
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02804750|
Recruitment Status : Completed
First Posted : June 17, 2016
Results First Posted : September 25, 2019
Last Update Posted : October 15, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Cushing's Syndrome||Drug: CORT125134||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 2 Study of the Safety and Efficacy of CORT125134 in the Treatment of Endogenous Cushing's Syndrome|
|Actual Study Start Date :||June 2016|
|Actual Primary Completion Date :||September 2018|
|Actual Study Completion Date :||September 2018|
Experimental: Group 1: Low-dose Group
100 mg/day for 4 weeks in Period 1, then 150 mg/day for 4 weeks in Period 2, then 200 mg/day for 4 weeks in Period 3. There was no washout between treatment periods. Period 3 was followed by a 4-week follow-up period. Per-protocol, Group 1 did not participate in treatment Period 4.
Experimental: Group 2: High-dose Group
250 mg/day for 4 weeks in Period 1, then 300 mg/day for 4 weeks in Period 2, then 350 mg/day for 4 weeks in Period 3, then 400 mg/day for 4 weeks in Period 4. There was no washout between treatment periods. Period 4 was followed by a 4-week follow-up period.
- Percentage of Participants With One or More Adverse Events [ Time Frame: Group 1: up to Week 16; Group 2: up to Week 20 ]All treatment-emergent adverse events were recorded and summarized.
- Percentage of Participants With One or More Severe (≥Grade 3) Adverse Events [ Time Frame: Group 1: up to Week 16; Group 2: up to Week 20 ]All treatment-emergent adverse events with Common Terminology Criteria for Adverse Events (CTCAE) ≥Grade 3 (severe) were recorded and summarized.
- Percentage of Participants With Hypertension Who Experience Improvement in Blood Pressure Following Treatment With CORT125134 [ Time Frame: Group 1: Week 12 or last observation; Group 2: Week 16 or last observation ]Improvement in blood pressure was defined as a participant who experiences at least a 5 mmHg decrease in mean diastolic or systolic BP from baseline who has not taken an additional antihypertensive medication during the treatment period or increased the dosage of a concurrent antihypertensive medication.
- Percentage of Participants With IGT / T2DM Who Experienced a ≥25% Reduction in AUCglucose Following Treatment With CORT125134 [ Time Frame: Before and 0.5, 1, 1.5, and 2 hours after a glucose drink at Week 12 or last observation (Group 1) or Week 16 or last observation (Group 2) ]Improvement in glucose control was defined as a participant who experiences at least a 25% decrease from baseline in area under the concentration-time curve for blood glucose (AUCglucose) who has not taken an additional diabetes medication during the treatment period or increased the dosage of a concurrent diabetes medication.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02804750
|United States, California|
|Laguna Hills, California, United States, 92653|
|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, Kentucky|
|Covington, Kentucky, United States, 41011|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|United States, Missouri|
|Saint Louis, Missouri, United States, 63110|
|United States, New York|
|New York, New York, United States, 10016|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|United States, Pennsylvania|
|Pittsburgh, Pennsylvania, United States, 15212|
|United States, Virginia|
|Richmond, Virginia, United States, 23119|
|Salford, Manchester, United Kingdom|
|Study Director:||Andreas G Moraitis, MD||Corcept Therapeutics|