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An Extension Study of CORLUX in the Treatment of Endogenous Cushing's Syndrome

Primary Purpose

Cushing's Syndrome

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
mifepristone
Sponsored by
Corcept Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cushing's Syndrome focused on measuring Cushing's Disease, Cushing's Syndrome, Cushings, Pituitary, ACTH, Adrenocorticotropic hormone, Ectopic, Adrenal adenoma, Adrenal carcinoma, Adrenal autonomy, Cortisol, Hypercortisolemia, Cushingoid, Moon facies, Dorsocervical fat, Plethora, Hirsutism, Violaceous striae, Hormone, Contraceptive, Endocrine, Cushing Syndrome, Ectopic ACTH Secretion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Have completed the Week 24 visit and the 6-Week Follow-up visit of Corcept Study C-1073-400 (NCT00569582).
  • In the opinion of the Investigator, are expected to maintain clinical benefit from mifepristone.
  • Women of childbearing potential have a negative serum pregnancy test at Entry.
  • Women of childbearing potential must be willing to use non-hormonal, medically acceptable methods of contraception during the study.
  • Are able to provide written informed consent
  • Are able to return to the investigative site to complete the study evaluations outlined in the protocol.
  • Will not use systemic estrogens during the study.

Exclusion Criteria:

  • Have an acute or unstable medical problem, which could be aggravated by mifepristone treatment.
  • Are taking medications within 14 days of the Entry visit that a) have a large first pass metabolism that is largely mediated by CYP3A4 and which have 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) other than CORLUX (mifepristone) within 30 days of Entry
  • Have a history of an allergic reaction or intolerance to CORLUX (mifepristone)
  • Have uncorrected hypokalemia (potassium level of <3.5 mEq/L) at Entry. Spironolactone or eplerenone is allowed to control hypokalemia.
  • Postmenopausal women with a history of endometrial hyperplasia with atypia or pathological features consistent with endometrial carcinoma.
  • Thickened endometrium on the Entry Visit transvaginal ultrasound that has not resolved after induction of menstrual bleeding with progesterone.
  • Uncontrolled, clinically significant hypothyroidism or hyperthyroidism.
  • Any woman with an intact uterus who has a hemorrhagic disorder or is being treated with an anticoagulant (e.g. warfarin, heparin).
  • Have renal failure as defined by a serum creatinine of ≥2.2 mg/dL.
  • Elevated total bilirubin >1.5 ULN, elevated ALT or AST ≥3X the upper limit of normal.

Sites / Locations

  • University of Alabama at Birmingham School of Medicine
  • AMCR Institute Inc.
  • Stanford University Medical Center
  • The Center for Diabetes and Endocrine Care
  • Northwestern University Feinberg Medical; Division of Endocrinology, Metabolism & Molecular Medicine
  • Sinai Hospital of Baltimore
  • Massachusetts General Hospital
  • University of Michigan Medical Center
  • University of Mississippi Medical Center
  • University of New Mexico
  • Cleveland Clinic Foundation; Dept of Endocrinology, Diabetes & Metabolism
  • Oklahoma Diabetes Center
  • Oregon Health Sciences University
  • University of Texas Southwestern Medical Center
  • Endocrinology Center at Community Medical Commons

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mifepristone

Arm Description

Mifepristone 300mg to 1200mg once daily

Outcomes

Primary Outcome Measures

Number of Participants With Adverse Events
Subjects who received at least one dose of mifepristone were included in the safety analysis.

Secondary Outcome Measures

The Long-term Benefit of Mifepristone Treatment in Cushing's Syndrome as Measured by Changes in the Score on the Physician's Global Assessment of Disease Severity
The mean Investigator's rating of the change in subject's signs and symptoms of Cushing's syndrome from Baseline (Entry into C1073-415) to Endpoint on the Physician's Global Assessment of Disease Severity was ranked on a 9-point scale (9 = much worse, 7 = worse, 5 = no change, 3 = better, 1 = much better). Higher scores indicate more severe illness. Scoring was done at all visits except the 6 Week Follow-up visit; the final visit result (Endpoint) is reported here. The instruction was "Rate the change in the subject's signs and symptoms of Cushing's from Baseline (1 = much better to 9 = much worse)".

Full Information

First Posted
July 9, 2009
Last Updated
February 19, 2014
Sponsor
Corcept Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT00936741
Brief Title
An Extension Study of CORLUX in the Treatment of Endogenous Cushing's Syndrome
Official Title
An Open Label Extension Study of the Efficacy and Safety 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
July 2009 (undefined)
Primary Completion Date
September 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
Participants in study C-1073-400 (NCT00569582) will be invited to participate in this extension study to examine the long term safety of mifepristone in the treatment of the signs and symptoms of endogenous Cushing's syndrome. Total treatment duration may be up to 12 months or longer at the discretion of the Investigator.
Detailed Description
Up to 50 subjects will receive mifepristone daily. Subjects completing 24 weeks of mifepristone treatment under Corcept protocol C1073-400 (NCT00569582) will be eligible to continue treatment for an additional 1 year. Assessments of safety, as evaluated by physical examinations, vital signs, laboratory tests and adverse events, will be made. Persistence of improvement in response to mifepristone treatment will also be evaluated during this extension study by assessing the continued or sustained improvement in the signs and symptoms of Cushing's syndrome.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cushing's Syndrome
Keywords
Cushing's Disease, Cushing's Syndrome, Cushings, Pituitary, ACTH, Adrenocorticotropic hormone, Ectopic, Adrenal adenoma, Adrenal carcinoma, Adrenal autonomy, Cortisol, Hypercortisolemia, Cushingoid, Moon facies, Dorsocervical fat, Plethora, Hirsutism, Violaceous striae, Hormone, Contraceptive, Endocrine, Cushing Syndrome, 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
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mifepristone
Arm Type
Experimental
Arm Description
Mifepristone 300mg to 1200mg once daily
Intervention Type
Drug
Intervention Name(s)
mifepristone
Other Intervention Name(s)
CORLUX
Intervention Description
Mifepristone 300 mg to 1200 mg once daily
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events
Description
Subjects who received at least one dose of mifepristone were included in the safety analysis.
Time Frame
Up to three years.
Secondary Outcome Measure Information:
Title
The Long-term Benefit of Mifepristone Treatment in Cushing's Syndrome as Measured by Changes in the Score on the Physician's Global Assessment of Disease Severity
Description
The mean Investigator's rating of the change in subject's signs and symptoms of Cushing's syndrome from Baseline (Entry into C1073-415) to Endpoint on the Physician's Global Assessment of Disease Severity was ranked on a 9-point scale (9 = much worse, 7 = worse, 5 = no change, 3 = better, 1 = much better). Higher scores indicate more severe illness. Scoring was done at all visits except the 6 Week Follow-up visit; the final visit result (Endpoint) is reported here. The instruction was "Rate the change in the subject's signs and symptoms of Cushing's from Baseline (1 = much better to 9 = much worse)".
Time Frame
Up to three years.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have completed the Week 24 visit and the 6-Week Follow-up visit of Corcept Study C-1073-400 (NCT00569582). In the opinion of the Investigator, are expected to maintain clinical benefit from mifepristone. Women of childbearing potential have a negative serum pregnancy test at Entry. Women of childbearing potential must be willing to use non-hormonal, medically acceptable methods of contraception during the study. Are able to provide written informed consent Are able to return to the investigative site to complete the study evaluations outlined in the protocol. Will not use systemic estrogens during the study. Exclusion Criteria: Have an acute or unstable medical problem, which could be aggravated by mifepristone treatment. Are taking medications within 14 days of the Entry visit that a) have a large first pass metabolism that is largely mediated by CYP3A4 and which have 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) other than CORLUX (mifepristone) within 30 days of Entry Have a history of an allergic reaction or intolerance to CORLUX (mifepristone) Have uncorrected hypokalemia (potassium level of <3.5 mEq/L) at Entry. Spironolactone or eplerenone is allowed to control hypokalemia. Postmenopausal women with a history of endometrial hyperplasia with atypia or pathological features consistent with endometrial carcinoma. Thickened endometrium on the Entry Visit transvaginal ultrasound that has not resolved after induction of menstrual bleeding with progesterone. Uncontrolled, clinically significant hypothyroidism or hyperthyroidism. Any woman with an intact uterus who has a hemorrhagic disorder or is being treated with an anticoagulant (e.g. warfarin, heparin). Have renal failure as defined by a serum creatinine of ≥2.2 mg/dL. Elevated total bilirubin >1.5 ULN, elevated ALT or AST ≥3X the upper limit of normal.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Coleman Gross, MD
Organizational Affiliation
Corcept Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham School of Medicine
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
AMCR Institute Inc.
City
Escondido
State/Province
California
ZIP/Postal Code
92026
Country
United States
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5826
Country
United States
Facility Name
The Center for Diabetes and Endocrine Care
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Northwestern University Feinberg Medical; Division of Endocrinology, Metabolism & Molecular Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Sinai Hospital of Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
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
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Cleveland Clinic Foundation; Dept of Endocrinology, Diabetes & Metabolism
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Oklahoma Diabetes Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Oregon Health Sciences University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-8857
Country
United States
Facility Name
Endocrinology Center at Community Medical Commons
City
Menomonee Falls
State/Province
Wisconsin
ZIP/Postal Code
53051
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26507877
Citation
Fein HG, Vaughan TB 3rd, Kushner H, Cram D, Nguyen D. Sustained weight loss in patients treated with mifepristone for Cushing's syndrome: a follow-up analysis of the SEISMIC study and long-term extension. BMC Endocr Disord. 2015 Oct 27;15:63. doi: 10.1186/s12902-015-0059-5.
Results Reference
derived
PubMed Identifier
25013998
Citation
Fleseriu M, Findling JW, Koch CA, Schlaffer SM, Buchfelder M, Gross C. Changes in plasma ACTH levels and corticotroph tumor size in patients with Cushing's disease during long-term treatment with the glucocorticoid receptor antagonist mifepristone. J Clin Endocrinol Metab. 2014 Oct;99(10):3718-27. doi: 10.1210/jc.2014-1843. Epub 2014 Jul 11.
Results Reference
derived
Links:
URL
http://clinicaltrials.gov/ct2/show/NCT00569582
Description
Corcept C-1073-400 Clinicaltrials.gov Study Listing

Learn more about this trial

An Extension Study of CORLUX in the Treatment of Endogenous Cushing's Syndrome

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