Study to Evaluate CORT125134 in Participants With Cushing's Syndrome

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02804750
• Other study ID #: CORT125134-451
• Status: Completed
• Phase: Phase 2
• Start date: June 2016
• Est. completion date: September 2018

Study information

• Verified date: October 2019
• Source: Corcept Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Has a confirmed diagnosis of endogenous Cushing's syndrome.

2. Requires medical treatment of hypercortisolemia.

3. Meets at least one of the following criteria:

1. Has type 2 diabetes mellitus.

2. Has impaired glucose tolerance.

3. Has hypertension.

Exclusion Criteria:

1. Has non-endogenous source of hypercortisolemia

2. Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism

3. Has poorly controlled hypertension

4. Has Stage = 4 renal failure

Related Conditions & MeSH terms

• Cushing Syndrome
• Cushing's Syndrome
• Syndrome

Intervention

Drug:
• CORT125134

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Corcept Therapeutics

Countries where clinical trial is conducted

United States,  Hungary,  Italy,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With One or More Adverse Events	All treatment-emergent adverse events were recorded and summarized.	Group 1: up to Week 16; Group 2: up to Week 20
Primary	Percentage of Participants With One or More Severe (=Grade 3) Adverse Events	All treatment-emergent adverse events with Common Terminology Criteria for Adverse Events (CTCAE) =Grade 3 (severe) were recorded and summarized.	Group 1: up to Week 16; Group 2: up to Week 20
Secondary	Percentage of Participants With Hypertension Who Experience Improvement in Blood Pressure Following Treatment With CORT125134	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.	Group 1: Week 12 or last observation; Group 2: Week 16 or last observation
Secondary	Percentage of Participants With IGT / T2DM Who Experienced a =25% Reduction in AUCglucose Following Treatment With CORT125134	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.	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)