Study to Evaluate CORT125134 in Participants With Cushing's Syndrome
NCT ID: NCT02804750
Last Updated: 2019-10-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
35 participants
INTERVENTIONAL
2016-06-30
2018-09-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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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.
CORT125134
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.
CORT125134
Interventions
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CORT125134
Eligibility Criteria
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Inclusion Criteria
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
2. Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism
3. Has poorly controlled hypertension
4. Has Stage ≥ 4 renal failure
18 Years
80 Years
ALL
No
Sponsors
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Corcept Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Andreas G Moraitis, MD
Role: STUDY_DIRECTOR
Corcept Therapeutics
Locations
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Laguna Hills, California, United States
Aurora, Colorado, United States
Fort Lauderdale, Florida, United States
Miami, Florida, United States
Indianapolis, Indiana, United States
Covington, Kentucky, United States
Rochester, Minnesota, United States
St Louis, Missouri, United States
New York, New York, United States
Cleveland, Ohio, United States
Pittsburgh, Pennsylvania, United States
Richmond, Virginia, United States
Budapest, , Hungary
Pécs, , Hungary
Cuneo, , Italy
Messina, , Italy
Milan, , Italy
Naples, , Italy
Orbassano, , Italy
Roma, , Italy
Siena, , Italy
Torino, , Italy
Leiden, , Netherlands
Rotterdam, , Netherlands
Salford, Manchester, United Kingdom
Countries
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References
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Pivonello R, Munster PN, Terzolo M, Ferrigno R, Simeoli C, Puglisi S, Bali U, Moraitis AG. Glucocorticoid Receptor Antagonism Upregulates Somatostatin Receptor Subtype 2 Expression in ACTH-Producing Neuroendocrine Tumors: New Insight Based on the Selective Glucocorticoid Receptor Modulator Relacorilant. Front Endocrinol (Lausanne). 2022 Jan 4;12:793262. doi: 10.3389/fendo.2021.793262. eCollection 2021.
Pivonello R, Bancos I, Feelders RA, Kargi AY, Kerr JM, Gordon MB, Mariash CN, Terzolo M, Ellison N, Moraitis AG. Relacorilant, a Selective Glucocorticoid Receptor Modulator, Induces Clinical Improvements in Patients With Cushing Syndrome: Results From A Prospective, Open-Label Phase 2 Study. Front Endocrinol (Lausanne). 2021 Jul 14;12:662865. doi: 10.3389/fendo.2021.662865. eCollection 2021.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CORT125134-451
Identifier Type: -
Identifier Source: org_study_id
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