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Extension Study to Evaluate the Safety and Clinical Benefit of Long-Term Use of Relacorilant in Patients With Cushing Syndrome

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ClinicalTrials.gov Identifier: NCT03604198
Recruitment Status : Recruiting
First Posted : July 27, 2018
Last Update Posted : July 27, 2018
Sponsor:
Information provided by (Responsible Party):
Corcept Therapeutics

Brief Summary:
This is an open-label extension study to evaluate the long-term safety of relacorilant in patients with endogenous Cushing syndrome who successfully completed participation in a Corcept-sponsored study of relacorilant and may benefit from continuing treatment.

Condition or disease Intervention/treatment Phase
Cushing Syndrome Drug: relacorilant Phase 2

Detailed Description:

This study is designed to allow continued therapy with relacorilant, a potent, selective glucocorticoid receptor (GR) antagonist in patients who have successfully completed participation of a Corcept-sponsored study of relacorilant (referred to as the "parent" study). Patients may qualify to enter this extension study if they complete their last treatment visit in their parent study and in the Investigator's opinion will benefit from continued treatment.

Once-daily dosing with relacorilant may continue for patients who receive clinical benefits (as judged by the Investigator) until relacorilant is commercially or otherwise available or the study is stopped by the Sponsor. A patient's dose may be maintained, reduced, or increased based on individual response and tolerability.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Extension Study of the Safety of Relacorilant in the Treatment of the Signs and Symptoms of Cushing Syndrome
Actual Study Start Date : May 7, 2018
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021


Arm Intervention/treatment
Experimental: relacorilant (CORT125134) Drug: relacorilant
CORT125134 is supplied as capsules for oral dosing.
Other Name: CORT125134




Primary Outcome Measures :
  1. Long-term safety of relacorilant [ Time Frame: 36 months ]
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  2. Long-term safety of relacorilant [ Time Frame: 36 Months ]
    Changes in size from baseline in pituitary tumors based on magnetic resonance imaging (MRI) scans in patients with Cushing disease as measured by volume in cc


Secondary Outcome Measures :
  1. Changes from baseline in the Glycated hemoglobin (HbA1c) [ Time Frame: 36 Months ]
    in patients with diabetes mellitus (DM) or glucose intolerance

  2. Changes from baseline in systolic and diastolic blood pressure (BP) [ Time Frame: 36 Months ]
    By ambulatory BP measurements (ABPM) in patients with uncontrolled hypertension (HTN)

  3. Changes from baseline in Physician's Global Assessment of Disease Severity [ Time Frame: 36 Months ]
    On a scale of 1 to 9 (where 1 = absent and 9 = incapacitating)

  4. Changes from baseline in weight [ Time Frame: 36 Months ]
    measured in Kg

  5. Changes from baseline in waist circumference [ Time Frame: 36 Months ]
    measured in cm

  6. Changes in baseline in quality-of-life [ Time Frame: 36 Months ]
    Based on Cushing quality of life questionnaire 0 (worst) to 100 (best)

  7. Changes in baseline in sex steroid hormone [ Time Frame: 36 Months ]
    Testosterone and estradiol



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Major Inclusion Criteria:

    • Have completed a Corcept-sponsored study of relacorilant in endogenous Cushing syndrome with at least 80% compliance with the dosing schedule.
    • According to the Investigator's opinion will benefit from continuing treatment with relacorilant

Exclusion Criteria:

  • Major Exclusion Criteria:

    • Premature discontinuation from a relacorilant parent study.
    • Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism
    • Has poorly controlled hypertension
    • 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): NCT03604198


Contacts
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Contact: Clinical Trial Lead for 452 Study 650-327-3270 CorceptStudy452@corcept.com

Locations
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United States, Florida
Not Provided Recruiting
Fort Lauderdale, Florida, United States, 33312
United States, Indiana
Not Provided Recruiting
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Corcept Therapeutics
Investigators
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Study Director: Andreas G Moraitis, MD Corcept Therapeutics

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Responsible Party: Corcept Therapeutics
ClinicalTrials.gov Identifier: NCT03604198     History of Changes
Other Study ID Numbers: CORT125134-452
First Posted: July 27, 2018    Key Record Dates
Last Update Posted: July 27, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Corcept Therapeutics:
Cushing Syndrome
Cushing Disease
Cushing
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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Syndrome
Cushing Syndrome
Disease
Pathologic Processes
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases