Endogenous Cushing Syndrome MedDRA version: 24.0 Level: LLT Classification code 10011657 Term: Cushings syndrome System Organ Class: 10014698 - Endocrine disorders
Conditions
Interventions
Product Code: CORT125134
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: Relacorilant
CAS Number: 1496510-51-0
Current Sponsor code: CORT125134
Other descriptive name: (R)-(1-(4-FLUOROPHENYL
Sponsors
Corcept Therapeutics Incorporated
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Have completed a Corcept-sponsored study of relacorilant in endogenous Cushing syndrome. 2. According to Investigator’s opinion will benefit from treatment with relacorilant. 3. Provide written informed consent. 4. If a female of childbearing potential, patients must be willing to use a highly effective method of contraception from 30 days before study entry until 28 days after the last dose of study drug. Male patients with a female partner must agree to 2 forms of contraception, one of which must be a double-barrier method, from study entry until 28 days after the last dose of study drug. Highly effective methods of contraception are detailed in the protocol. 5. Are willing to continue to refrain from using drugs that inhibit steroid biosynthesis by the adrenal cortex or ACTH secretion by a pituitary or extrapituitary ACTH secreting tumor. 6. Are able to return to the investigative site to complete the study evaluations outlined in the protocol. 7. For patients with Cushing syndrome due to an ACTH-secreting pituitary tumor, are able to obtain pituitary MRI imaging (up to 6 months before starting treatment in this study, or up to 6 weeks after start of treatment in this study) to assess changes in tumor size during dosing. A CT scan can be used instead in patients for whom MRI is contraindicated. 8. For patients entering the study >12 weeks after completing the last dose in the parent study, confirmation of hypercortisolism consistent with the criteria of the parent study is required. 9. For patient who received treatment for hypercortisolism after their last dose in the parent study, confirmation of hypercortisolism consistent with the criteria of the parent study is required. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 45 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: 1. Have been prematurely discontinued from relacorilant study treatment in the parent study for any reason 2. Are planning to start another Cushing syndrome drug after starting participation in this extension study. 3. Have an acute or unstable medical problem that could be aggravated by relacorilant treatment or has known active COVID-19 infection at Screening. 4. Are taking the following medications from the times specified below before the Study CORT125134-452 Day 1 visit and/or through the entire study period: • Medications used in the treatment of Cushing syndrome, with the exception of relacorilant, are prohibited: – Adrenostatic medications: metyrapone, osilodrostat, ketoconazole, fluconazole, aminoglutethimide, or etomidate 4 weeks before Day 1 through the end of this study – Neuromodulator drugs that act at the hypothalamic-pituitary level: serotonin antagonists (cyproheptadine, ketanserin, ritanserin), dopamine agonists (bromocriptine, cabergoline), gamma-aminobutyric acid agonists (sodium valproate), and somatostatin receptor ligands (octreotide long-acting release [LAR], pasireotide LAR, lanreotide) from 8 weeks before Day 1 through the end of this study. Use of short-acting somatostatin analogs (octreotide, pasireotide) from 4 weeks before Day 1 through the end of this study. • Patients who require inhaled glucocorticoid use and have no alternative option if their condition deteriorates during the study. • Mifepristone, from 4 weeks before Day 1. • Ongoing use of any strong CYP3A inducers during treatment with relacorilant. • Has used mitotane prior to Day 1. • Ongoing use of antidiabetic, antihypertensive, antidepressant, and/or lipid-lowering medications that are highly dependent on CYP3A for clearance and that cannot undergo dose modifications upon coadministration with strong CYP3A inhibitors. 5. Plans for prolonged regular use of systemic glucocorticoids from Day 1 through the end of the study. 6. Have received investigational treatment (drug, biological agent, or device) other than relacorilant within 4 weeks of study entry, or within 5 times the drug’s half-life, whichever is longer. 7. Have a history of an allergic reaction or intolerance to relacorilant. 8. Have uncorrected clinically significant hypokalemia (potassium level of 1.5 × the ULN or elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) =3 × ULN. 12. Have a clinically significant ECG abnormality at baseline, which, in the opinion of the Investigator, will make the patient an unsuitable candidate for the study. 13. Have a confirmed baseline QT interval corrected using Fridericia’s formula (QTcF) of >450 ms for males and >470 ms for females in the presence of a normal QRS interval (QRS 500 ms with a wide QRS interval (=120 ms),or a history of additional risk factors for torsades de pointes. 14. Has received stereotactic radiation therapy for a Cushing syndrome-related tumor within 24 months of Baseline or conventional pituitary radiation therapy within 36 months of Baseline. 15. Has undergone pituitary surgery <3 months prior to Screening. 16. Has plans for adrenalectomy or nodulectomy during the study, including follow-up. 17. Female who is pregnant or la
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the long-term safety of relacorilant in the treatment of the signs and symptoms of endogenous Cushing syndrome;Secondary Objective: Not applicable;Primary end point(s): • Incidence of treatment-emergent adverse events (TEAEs) (assessed monthly): TEAEs, serious TEAEs (SAEs), treatment-related TEAEs, TEAEs leading to early discontinuation of study treatment. • Changes from baseline in clinical laboratory tests (hematology and chemistry panels). • Changes from baseline in physical examinations and vital sign measurements. • Changes from baseline in electrocardiograms (ECG) (12-lead) (including QTcF interval, QRS complex, PR interval, and heart rate). • Changes from baseline in pituitary tumors based on magnetic resonance imaging (MRI) scans in patients with Cushing disease.;Timepoint(s) of evaluation of this end point: • AEs: all visits • Physical examination, vital signs: screening, baseline, every 1, 3 and 6 months, End of Treatment (EoT) and follow-up (F/up). For patients requiring dose titration additionally at Weeks 2, 6, 10 and 14. •Clinical laboratory measurements: screening, baseline, every 3 & 6 months, EoT and F/up. For patients requiring dose titration additionally at Weeks 6, 10 and 14. •12-Lead ECG: Screening, baseline, EoT, F/up. For patients requiring dose titration additionally at Week 14. • Pituitary MRI scan: baseline (if applicable), every 6 months, EoT • Coagulation Panel, DXA Scan and Photographs: Baseline, Month 12, Month 24, EoT | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not Applicable;Timepoint(s) of evaluation of this end point: Not Applicable | — |
Countries
Austria, Bulgaria, Canada, Germany, Hungary, Israel, Italy, Netherlands, Poland, Romania, Spain, United States
Contacts
Public ContactClinical Operations
Corcept Therapeutics Incorporated
Outcome results
None listed