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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
Sponsor:
Information provided by (Responsible Party):
Corcept Therapeutics

Study Description
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Brief Summary:
This is a compassionate use study. In addition to providing compassionate use access to mifepristone, objectives of the study will be to evaluate the safety and utility of mifepristone in the treatment of the signs and symptoms of endogenous Cushing's syndrome when given on a compassionate use basis. The study will only enroll subjects whose physicians have determined that medical treatment is needed to control the symptoms or signs of hypercortisolemia.

Condition or disease Intervention/treatment Phase
Cushing's Disease Cushing's Syndrome Drug: Mifepristone Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
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

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Arms and Interventions
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Arm Intervention/treatment
Experimental: mifepristone Drug: Mifepristone
mifepristone at doses from 300mg/day up to 1200mg/day
Other Name: CORLUX®


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Adverse Events [ Time Frame: 6 months ]
    Safety was assessed at all visits and adverse events were recorded.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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
  2. Have documented biochemical evidence of endogenous hypercortisolemia which includes elevated urinary free cortisol.
  3. 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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Corcept Therapeutics
Investigators
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Study Director: Coleman Gross, M.D. Corcept Therapeutics
More Information
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Responsible Party: Corcept Therapeutics
ClinicalTrials.gov Identifier: NCT01371565     History of Changes
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

Keywords provided by Corcept Therapeutics:
Cushing's Disease
Cushing's Syndrome
Cushings
Pituitary
Ectopic ACTH secretion

Additional relevant MeSH terms:
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Syndrome
Signs and Symptoms
Cushing Syndrome
Pituitary ACTH Hypersecretion
ACTH-Secreting Pituitary Adenoma
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