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OpenTrials
Active, not recruiting

NCT Number: NCT03604198

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

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Cushing Syndrome ACTH Syndrome, Ectopic Adenocarcinoma Adrenal Cortex Diseases Adrenal Cortex Neoplasms Adrenal Gland Diseases Adrenal Gland Neoplasms Adrenocortical Carcinoma Adrenocortical Hyperfunction Brain Diseases Carcinoma Cardiovascular Diseases Central Nervous System Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine Gland Neoplasms Endocrine System Diseases Glucose Metabolism Disorders Hyperpituitarism Hypertension Hypothalamic Diseases Metabolic Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Nervous System Diseases Nutritional and Metabolic Diseases Paraneoplastic Endocrine Syndromes Paraneoplastic Syndromes Pituitary ACTH Hypersecretion Pituitary Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Site 51, Nova Scotia, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Major Inclusion Criteria:
  • Have completed a Corcept-sponsored study of relacorilant in endogenous Cushing syndrome
  • 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.

Treatment and study plan

Relacorilant

Drug

CORT125134 is supplied as capsules for oral dosing.

Other names: CORT125134

Primary outcomes

  1. Long-term safety of relacorilant

    Time frame: 36 months

    Number of patients with treatment-emergent adverse events (TEAEs) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 or higher

Other outcomes

  1. Number of patients with one or more hematology laboratory abnormality by severity grade

    Time frame: Up to Month 99

    The hematology laboratory abnormalities to be assessed are hemoglobin decreased, hemoglobin increased, platelet count decreased, white blood cell count decreased, leukocytosis, eosinophilia, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased. The laboratory abnormalities will be reported by worst grade of mild, moderate, severe, or life-threatening, using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, version 4 or higher) criteria.

  2. Number of patients with one or more clinical chemistry laboratory abnormality by severity grade

    Time frame: Up to Month 99

    The clinical chemistry laboratory abnormalities to be assessed are hypoalbuminemia, alkaline phosphatase increased, alanine aminotransferase increased, aspartate aminotransferase increased, hypocalcemia, hypercalcemia, creatine increased, hypoglycemia, hyperglycemia, blood lactate dehydrogenase increased, hypomagnesemia, hypermagnesemia, hypokalemia, hyperkalemia, hyponatremia, hypernatremia, creatine phosphokinase increased, blood bilirubin increased, and hyperuricemia. The laboratory abnormalities will be reported by worst grade of mild, moderate, severe, or life-threatening, using the CTCAE, version 4 or higher criteria.

  3. Change from Baseline in oral body temperature

    Time frame: Baseline and up to Month 99

  4. Change from Baseline in respiratory rate

    Time frame: Baseline and up to Month 99

  5. Change from Baseline in blood pressure

    Time frame: Baseline and up to Month 99

    Systolic and diastolic blood pressure will be assessed.

  6. Change from Baseline in heart rate

    Time frame: Baseline and up to Month 99

  7. Change from Baseline in electrocardiogram (ECG) parameters

    Time frame: Baseline and Month 3

    12-lead ECGs will be performed in duplicate and will be evaluated by a central reviewer. The parameters to be assessed are PR interval, QRS interval, QT interval, RR interval, QTcF interval, and QTcB interval.

  8. Change from Baseline in ECG ventricular rate

    Time frame: Baseline and Month 3

    12-lead ECGs will be performed in duplicate and will be evaluated by a central reviewer.

  9. Change from Baseline in the longest vertical diameter of pituitary tumors as determined with magnetic resonance imaging (MRI)

    Time frame: Baseline and up to Month 72

    Pituitary MRI imaging will be used to assess changes in tumor size during dosing. A computed tomography (CT) scan can be used in patients for whom MRI is contraindicated.

  10. Change from baseline in the volume of pituitary tumors as determined with MRI

    Time frame: Baseline and up to Month 72

    Pituitary MRI imaging will be used to assess changes in tumor size during dosing. A CT scan can be used in patients for whom MRI is contraindicated.

Sponsors and collaborators

Lead sponsor

Corcept Therapeutics

Industry

Registry information

Official study title

An Open-Label Extension Study of the Safety of Relacorilant (CORT125134) in the Treatment of the Signs and Symptoms of Endogenous Cushing Syndrome

Important dates

Study start
2018
Primary completion
2026
Study completion
2026
First posted
Jul 27, 2018
Registry last updated
Aug 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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