Compassionate Use of CORLUX® (Mifepristone) in the Treatment of Signs and Symptoms of Endogenous Cushing's Syndrome
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ClinicalTrials.gov Identifier: NCT01371565 |
Recruitment Status :
Completed
First Posted : June 13, 2011
Results First Posted : November 20, 2013
Last Update Posted : March 18, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cushing's Disease Cushing's Syndrome | Drug: Mifepristone | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 4 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Compassionate Use Protocol for the Administration of CORLUX® (Mifepristone) in the Treatment of the Signs and Symptoms of Endogenous Cushing's Syndrome |
Study Start Date : | November 2010 |
Actual Primary Completion Date : | June 2012 |
Actual Study Completion Date : | September 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: mifepristone |
Drug: Mifepristone
mifepristone at doses from 300mg/day up to 1200mg/day
Other Name: CORLUX® |
- Number of Participants With Adverse Events [ Time Frame: 6 months ]Safety was assessed at all visits and adverse events were recorded.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
-
Have a confirmed diagnosis of endogenous hypercortisolemia caused by ACTH dependent or ACTH independent etiologies including:
-
Cushing's Disease that (more than one may apply)
- has recurred after primary pituitary surgery
- has persisted despite pituitary surgery (failed pituitary surgery)
- has been treated with radiation therapy to the pituitary
- is not treatable with surgery
- exists in subjects who are not candidates for or who refuse surgery
- Ectopic ACTH
- Ectopic CRF secretion
- Adrenal adenoma
- Adrenal carcinoma
- Adrenal autonomy
-
- Have documented biochemical evidence of endogenous hypercortisolemia which includes elevated urinary free cortisol.
- Require medical treatment of hypercortisolemia.
Exclusion Criteria:
Individuals not eligible to be enrolled into the study are those who:
- 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.
- Postmenopausal women with an intact uterus who have experienced unexplained vaginal bleeding within 12 months of Screening are excluded.

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): NCT01371565
United States, Florida | |
The Center for Diabetes and Endocrine Care | |
Hollywood, Florida, United States, 33021 | |
United States, Maryland | |
Sinai Hospital of Baltimore | |
Baltimore, Maryland, United States, 21215 | |
United States, Michigan | |
University of Michigan Medical Center | |
Ann Arbor, Michigan, United States, 48109 | |
United States, Ohio | |
Cleveland Clinic Foundation | |
Cleveland, Ohio, United States, 44195 | |
The Ohio State University, Division of Endocrinology Diabetes and Metabolism | |
Columbus, Ohio, United States, 43210 |
Study Director: | Coleman Gross, M.D. | Corcept Therapeutics |
Responsible Party: | Corcept Therapeutics |
ClinicalTrials.gov Identifier: | NCT01371565 |
Other Study ID Numbers: |
C1073-405 |
First Posted: | June 13, 2011 Key Record Dates |
Results First Posted: | November 20, 2013 |
Last Update Posted: | March 18, 2014 |
Last Verified: | February 2014 |
Cushing's Disease Cushing's Syndrome Cushings Pituitary Ectopic ACTH secretion |
ACTH-Secreting Pituitary Adenoma Pituitary ACTH Hypersecretion Cushing Syndrome Syndrome Disease Pathologic Processes Adrenocortical Hyperfunction Adrenal Gland Diseases Endocrine System Diseases Hyperpituitarism Pituitary Diseases Hypothalamic Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Pituitary Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Mifepristone Abortifacient Agents, Steroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs Contraceptives, Oral, Synthetic Contraceptives, Oral Contraceptive Agents, Female |