Back to resultsCompassionate Use of CORLUX® (Mifepristone) in the Treatment of Signs and Symptoms of Endogenous Cushing's Syndrome
Primary Purpose
Cushing's Disease, Cushing's Syndrome
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Mifepristone
Sponsored by
About this trial
This is an interventional treatment trial for Cushing's Disease focused on measuring Cushing's Disease, Cushing's Syndrome, Cushings, Pituitary, Ectopic ACTH secretion
Eligibility Criteria
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.
Sites / Locations
- The Center for Diabetes and Endocrine Care
- Sinai Hospital of Baltimore
- University of Michigan Medical Center
- Cleveland Clinic Foundation
- The Ohio State University, Division of Endocrinology Diabetes and Metabolism
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
mifepristone
Arm Description
Outcomes
Primary Outcome Measures
Number of Participants With Adverse Events
Safety was assessed at all visits and adverse events were recorded.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01371565
Brief Title
Compassionate Use of CORLUX® (Mifepristone) in the Treatment of Signs and Symptoms of Endogenous Cushing's Syndrome
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 Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Corcept Therapeutics
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cushing's Disease, Cushing's Syndrome
Keywords
Cushing's Disease, Cushing's Syndrome, Cushings, Pituitary, Ectopic ACTH secretion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
mifepristone
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Mifepristone
Other Intervention Name(s)
CORLUX®
Intervention Description
mifepristone at doses from 300mg/day up to 1200mg/day
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events
Description
Safety was assessed at all visits and adverse events were recorded.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Coleman Gross, M.D.
Organizational Affiliation
Corcept Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
The Center for Diabetes and Endocrine Care
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Sinai Hospital of Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
University of Michigan Medical Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
The Ohio State University, Division of Endocrinology Diabetes and Metabolism
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Compassionate Use of CORLUX® (Mifepristone) in the Treatment of Signs and Symptoms of Endogenous Cushing's Syndrome
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