Study to Evaluate CORT125134 in Participants With Cushing's Syndrome

October 7, 2019 updated by: Corcept Therapeutics

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Budapest, Hungary
      • Pecs, Hungary
  • Italy
      • Cuneo, Italy
      • Messina, Italy
      • Milano, Italy
      • Naples, Italy
      • Orbassano, Italy
      • Roma, Italy
      • Siena, Italy
      • Torino, Italy
  • Netherlands
      • Leiden, Netherlands
      • Rotterdam, Netherlands
  • United Kingdom
    • Manchester
      • Salford, Manchester, United Kingdom
  • United States
    • California
      • Laguna Hills, California, United States, 92653
    • Colorado
      • Aurora, Colorado, United States, 80045
    • Florida
      • Fort Lauderdale, Florida, United States, 33312
      • Miami, Florida, United States, 33136
    • Indiana
      • Indianapolis, Indiana, United States, 46202
    • Kentucky
      • Covington, Kentucky, United States, 41011
    • Minnesota
      • Rochester, Minnesota, United States, 55905
    • Missouri
      • Saint Louis, Missouri, United States, 63110
    • New York
      • New York, New York, United States, 10016
    • Ohio
      • Cleveland, Ohio, United States, 44195
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
    • Virginia
      • Richmond, Virginia, United States, 23119

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: CORT125134
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.
Drug: CORT125134

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Group 1: up to Week 16; Group 2: up to Week 20
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.
Group 1: up to Week 16; Group 2: up to Week 20

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Group 1: Week 12 or last observation; Group 2: Week 16 or last observation
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.
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corcept Therapeutics

Investigators

  • Study Director: Andreas G Moraitis, MD, Corcept Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Actual)

September 1, 2018

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

June 15, 2016

First Submitted That Met QC Criteria

June 15, 2016

First Posted (Estimate)

June 17, 2016

Study Record Updates

Last Update Posted (Actual)

October 15, 2019

Last Update Submitted That Met QC Criteria

October 7, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CORT125134-451

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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