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

Cushing's Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00936741
• Other study ID #: C-1073-415
• Status: Completed
• Phase: Phase 3
• First received: July 9, 2009
• Last updated: February 19, 2014
• Start date: July 2009
• Est. completion date: September 2012

Study information

• Verified date: February 2014
• Source: Corcept Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cushing Syndrome
• Cushing's Syndrome
• Syndrome

Intervention

Drug:
• mifepristone
Mifepristone 300 mg to 1200 mg once daily

Locations

Country	Name	City	State
United States	University of New Mexico	Albuquerque	New Mexico
United States	University of Michigan Medical Center	Ann Arbor	Michigan
United States	Sinai Hospital of Baltimore	Baltimore	Maryland
United States	University of Alabama at Birmingham School of Medicine	Birmingham	Alabama
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Northwestern University Feinberg Medical; Division of Endocrinology, Metabolism & Molecular Medicine	Chicago	Illinois
United States	Cleveland Clinic Foundation; Dept of Endocrinology, Diabetes & Metabolism	Cleveland	Ohio
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	AMCR Institute Inc.	Escondido	California
United States	The Center for Diabetes and Endocrine Care	Hollywood	Florida
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Endocrinology Center at Community Medical Commons	Menomonee Falls	Wisconsin
United States	Oklahoma Diabetes Center	Oklahoma City	Oklahoma
United States	Oregon Health Sciences University	Portland	Oregon
United States	Stanford University Medical Center	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Corcept Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events	Subjects who received at least one dose of mifepristone were included in the safety analysis.	Up to three years.	No
Secondary	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)".	Up to three years.	No

External Links

•   Corcept C-1073-400 Clinicaltrials.gov Study Listing