A Study of the Efficacy and Safety of CORLUX in the Treatment of Endogenous Cushing's Syndrome
NCT ID: NCT00569582
Last Updated: 2013-08-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
50 participants
INTERVENTIONAL
2007-12-31
Brief Summary
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Detailed Description
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This will evaluate the safety and efficacy of mifepristone for treatment of the signs and symptoms of hypercortisolemia in patients with endogenous Cushing's syndrome from ACTH-dependent or adrenal disorders.
The study will enroll subjects for whom the investigator has determined that medical treatment of endogenous hypercortisolemia is needed. Medical treatment may be intended to treat the effects of persistent or recurrent hypercortisolemia after surgery and/or radiation for Cushing's syndrome, to bridge the period of time for radiation to become effective, or when surgery is not feasible.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
mifepristone
Patients take mifepristone by mouth once a day. The dose is increased during scheduled timepoints during the study or until symptoms improve or the highest dosage allowed is reached. Dose escalation will be based upon weight. During clinic visits, blood pressure, glucose tolerance and blood chemistries are measured and EKG and urinalysis will be performed.
Interventions
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mifepristone
Patients take mifepristone by mouth once a day. The dose is increased during scheduled timepoints during the study or until symptoms improve or the highest dosage allowed is reached. Dose escalation will be based upon weight. During clinic visits, blood pressure, glucose tolerance and blood chemistries are measured and EKG and urinalysis will be performed.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Are at least 18 years of age
* Have a confirmed diagnosis of endogenous hypercortisolemia caused by ACTH dependent or ACTH independent etiologies, including
1. Cushing's Disease (that has recurred after primary pituitary surgery, or has failed pituitary surgery, or has been treated with radiation therapy to the pituitary, or is not treatable with surgery, or exists in patients who are not candidates for surgery, and is confirmed by documentation of ACTH immuno-reactivity on a pathological evaluation of pituitary tissue from a previous surgical specimen or IPSS with a central-to-peripheral gradient (ratio) of \>2 before or \>3 after CRH administration).
2. Ectopic ACTH
3. Ectopic CRF secretion
4. Adrenal adenoma
5. Adrenal carcinoma
6. Adrenal autonomy
* Require medical treatment of hypercortisolemia
* Have diabetes mellitus type 2 or glucose intolerance AND/OR have hypertension \*Note: To be eligible for inclusion subjects must have documented evidence of persistent endogenous hypercortisolemia
Exclusion Criteria
* Have de novo Cushing's disease and are surgical candidates for pituitary surgery.
* Have an acute or unstable medical problem, which could be aggravated by mifepristone treatment.
* Taking medications within 14 days of the baseline visit (Day 1) that a) have a large first pass metabolism largely mediated by CYP3A4 and a narrow therapeutic margin and/or b) are strong CYP3A4 inhibitors.
* Female patients of reproductive potential, who are pregnant or who are unable or unwilling to use medically acceptable, non-hormonal methods of contraception during the study.
* Have received investigational treatment (drug, biological agent or device) within 30 days of Screening
* Have a history of an allergic reaction or intolerance to CORLUX (mifepristone)
* Have a non-endogenous source of hypercortisolemia such as factious hypercortisolemia (exogenous source of glucocorticoid, iatrogenic Cushing's syndrome), factious or therapeutic use of ACTH
* Have Pseudo-Cushing's syndrome.
* Receive PPARgamma agonist drugs (e.g. pioglitazone, rosiglitazone) within 4 months of Baseline (Day 1).
* Postmenopausal women with an intact uterus who have experienced unexplained vaginal bleeding within 12 months of Screening are excluded.
* Have renal failure as defined by a serum creatinine of ≥2.2 mg/dL.
18 Years
ALL
No
Sponsors
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Corcept Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Coleman Gross
Role: STUDY_DIRECTOR
Corcept Therapeutics
Locations
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University of Alabama at Birmingham School of Medicine
Birmingham, Alabama, United States
AMCR Institute Inc.
Escondido, California, United States
Stanford University Medical Center
Stanford, California, United States
The Center for Diabetes and Endocrine Care
Hollywood, Florida, United States
Northwestern University Feinberg Medical; Division of Endocrinology, Metabolism & Molecular Medicine
Chicago, Illinois, United States
The University of Chicago
Chicago, Illinois, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan Medical Center
Ann Arbor, Michigan, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
University of New Mexico HSC
Albuquerque, New Mexico, United States
Cleveland Clinic Foundation; Dept of Endocrinology, Diabetes & Metabolism
Cleveland, Ohio, United States
Oklahoma University Health Science Center
Oklahoma City, Oklahoma, United States
Oregon Health Sciences University
Portland, Oregon, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Diabetes and Glandular Disease Clinic
San Antonio, Texas, United States
Endocrinology Center at North Hills, Froedtert and Medical College of Wisconsin
Menomonee Falls, Wisconsin, United States
Countries
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References
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Sartor O, Cutler GB Jr. Mifepristone: treatment of Cushing's syndrome. Clin Obstet Gynecol. 1996 Jun;39(2):506-10. doi: 10.1097/00003081-199606000-00024.
Johanssen S, Allolio B. Mifepristone (RU 486) in Cushing's syndrome. Eur J Endocrinol. 2007 Nov;157(5):561-9. doi: 10.1530/EJE-07-0458.
Morris D, Grossman A. The medical management of Cushing's syndrome. Ann N Y Acad Sci. 2002 Sep;970:119-33. doi: 10.1111/j.1749-6632.2002.tb04418.x.
Chu JW, Matthias DF, Belanoff J, Schatzberg A, Hoffman AR, Feldman D. Successful long-term treatment of refractory Cushing's disease with high-dose mifepristone (RU 486). J Clin Endocrinol Metab. 2001 Aug;86(8):3568-73. doi: 10.1210/jcem.86.8.7740.
Agarwai MK. The antiglucocorticoid action of mifepristone. Pharmacol Ther. 1996;70(3):183-213. doi: 10.1016/0163-7258(96)00016-2.
Miller JW, Crapo L. The medical treatment of Cushing's syndrome. Endocr Rev. 1993 Aug;14(4):443-58. doi: 10.1210/edrv-14-4-443. No abstract available.
Nieman LK, Chrousos GP, Kellner C, Spitz IM, Nisula BC, Cutler GB, Merriam GR, Bardin CW, Loriaux DL. Successful treatment of Cushing's syndrome with the glucocorticoid antagonist RU 486. J Clin Endocrinol Metab. 1985 Sep;61(3):536-40. doi: 10.1210/jcem-61-3-536.
Fleseriu M, Biller BM, Findling JW, Molitch ME, Schteingart DE, Gross C; SEISMIC Study Investigators. Mifepristone, a glucocorticoid receptor antagonist, produces clinical and metabolic benefits in patients with Cushing's syndrome. J Clin Endocrinol Metab. 2012 Jun;97(6):2039-49. doi: 10.1210/jc.2011-3350. Epub 2012 Mar 30.
Fein HG, Vaughan TB 3rd, Kushner H, Cram D, Nguyen D. Sustained weight loss in patients treated with mifepristone for Cushing's syndrome: a follow-up analysis of the SEISMIC study and long-term extension. BMC Endocr Disord. 2015 Oct 27;15:63. doi: 10.1186/s12902-015-0059-5.
Fleseriu M, Findling JW, Koch CA, Schlaffer SM, Buchfelder M, Gross C. Changes in plasma ACTH levels and corticotroph tumor size in patients with Cushing's disease during long-term treatment with the glucocorticoid receptor antagonist mifepristone. J Clin Endocrinol Metab. 2014 Oct;99(10):3718-27. doi: 10.1210/jc.2014-1843. Epub 2014 Jul 11.
Wallia A, Colleran K, Purnell JQ, Gross C, Molitch ME. Improvement in insulin sensitivity during mifepristone treatment of Cushing syndrome: early and late effects. Diabetes Care. 2013 Sep;36(9):e147-8. doi: 10.2337/dc13-0246. No abstract available.
Related Links
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Corporate Website
Other Identifiers
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C-1073-400
Identifier Type: -
Identifier Source: org_study_id