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Compassionate Use of CORLUX® (Mifepristone) in the Treatment of Signs and Symptoms of Endogenous Cushing's Syndrome

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Corcept Therapeutics
ClinicalTrials.gov Identifier:
NCT01371565
First received: June 7, 2011
Last updated: September 4, 2012
Last verified: October 2011
History of Changes
  Purpose

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 Intervention Phase
Cushing's Disease
Cushing's Syndrome
 Drug: Mifepristone
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Corcept Therapeutics:

Primary Outcome Measures:
  • To examine 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. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    Subjects who have received at least 1 dose of mifepristone will be included in the safety evaluations. Safety will be evaluated by:

    1. Periodic physical examinations and evaluation of vital signs
    2. Assessment of adverse events
    3. Periodic laboratory evaluations including hematology, electrolytes, liver function, lipid tests
    4. Radiographic Procedures (transvaginal ultrasound in women with intact uterus and pituitary MRI in subjects with Cushing's Disease)


Estimated Enrollment: 25
Study Start Date: November 2010
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Mifepristone
    mifepristone at doses from 300mg/day up to 1200mg/day
    Other Name: CORLUX®
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01371565

Locations
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
Study Director: Coleman Gross, M.D. Corcept Therapeutics
  More Information

No publications provided

Responsible Party: Corcept Therapeutics
ClinicalTrials.gov Identifier: NCT01371565     History of Changes
Other Study ID Numbers: C1073-405
Study First Received: June 7, 2011
Last Updated: September 4, 2012
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Cushing Syndrome
Pituitary ACTH Hypersecretion
Signs and Symptoms
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Mifepristone
Contraceptives, Oral, Synthetic
Contraceptives, Oral
 Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents
Abortifacient Agents, Steroidal
Abortifacient Agents

ClinicalTrials.gov processed this record on June 18, 2013