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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

June 7, 2011
September 4, 2012
November 2010
October 2012   (final data collection date for primary outcome measure)
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)
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: Yes ]

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)
Complete list of historical versions of study NCT01371565 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Compassionate Use of CORLUX® (Mifepristone) in the Treatment of Signs and Symptoms of Endogenous Cushing's Syndrome
Compassionate Use Protocol for the Administration of CORLUX® (Mifepristone) in the Treatment of the Signs and Symptoms of Endogenous Cushing's Syndrome

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.
Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cushing's Disease
  • Cushing's Syndrome
Drug: Mifepristone
mifepristone at doses from 300mg/day up to 1200mg/day
Other Name: CORLUX®
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
25
Not Provided
October 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01371565
C1073-405
No
Corcept Therapeutics
Corcept Therapeutics
Not Provided
Study Director: Coleman Gross, M.D. Corcept Therapeutics
Corcept Therapeutics
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP