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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
Sponsor:
Information provided by (Responsible Party):
Corcept Therapeutics

Brief 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.


Condition or disease Intervention/treatment Phase
Cushing's Syndrome Drug: CORT125134 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Sequential 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
Actual Study Start Date : June 2016
Actual Primary Completion Date : September 2018
Actual Study Completion Date : September 2018


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



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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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
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
Salford, Manchester, United Kingdom
Sponsors and Collaborators
Corcept Therapeutics
Investigators
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Study Director: Andreas G Moraitis, MD Corcept Therapeutics
  Study Documents (Full-Text)

Documents provided by Corcept Therapeutics:
Study Protocol  [PDF] January 15, 2018
Statistical Analysis Plan  [PDF] August 30, 2018

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Responsible Party: Corcept Therapeutics
ClinicalTrials.gov Identifier: NCT02804750    
Other Study ID Numbers: CORT125134-451
First Posted: June 17, 2016    Key Record Dates
Results First Posted: September 25, 2019
Last Update Posted: October 15, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Corcept Therapeutics:
Cushing's Syndrome
Cushing's Disease
Cushing's
Hypercortisolemia
Cushingoid
Type 2 Diabetes
Impaired Glucose Intolerance
Hypertension
Adrenal Corticotrophic Hormone (ACTH)
Adrenocortical Carcinoma
Primary Pigmented Nodular Adrenal Disease (PPNAD)
Moon Facies
Dorsocervical Fat Pad
Adrenal Adenoma
Adrenal Carcinoma
Adrenal Autonomy
Cortisol
Additional relevant MeSH terms:
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Cushing Syndrome
Syndrome
Disease
Pathologic Processes
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases