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

NCT ID: NCT00936741

Last Updated: 2014-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2012-09-30

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.

Conditions

Cushing's Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mifepristone

Mifepristone 300mg to 1200mg once daily

Group Type: EXPERIMENTAL

mifepristone

Intervention Type: DRUG

Mifepristone 300 mg to 1200 mg once daily

Interventions

mifepristone

Mifepristone 300 mg to 1200 mg once daily

Intervention Type: DRUG

Other Intervention Names

CORLUX

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Corcept Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Coleman Gross, MD

Role: STUDY_DIRECTOR

Corcept Therapeutics

Locations

University of Alabama at Birmingham School of Medicine

Birmingham, Alabama, United States

AMCR Institute Inc.

Escondido, California, United States

Stanford University Medical Center

Stanford, California, United States

The Center for Diabetes and Endocrine Care

Hollywood, Florida, United States

Northwestern University Feinberg Medical; Division of Endocrinology, Metabolism & Molecular Medicine

Chicago, Illinois, United States

Sinai Hospital of Baltimore

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

University of Michigan Medical Center

Ann Arbor, Michigan, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

University of New Mexico

Albuquerque, New Mexico, United States

Cleveland Clinic Foundation; Dept of Endocrinology, Diabetes & Metabolism

Cleveland, Ohio, United States

Oklahoma Diabetes Center

Oklahoma City, Oklahoma, United States

Oregon Health Sciences University

Portland, Oregon, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Endocrinology Center at Community Medical Commons

Menomonee Falls, Wisconsin, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 26507877 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25013998 (View on PubMed)

Related Links

http://clinicaltrials.gov/ct2/show/NCT00569582

Corcept C-1073-400 Clinicaltrials.gov Study Listing

Other Identifiers

C-1073-415

Identifier Type: -

Identifier Source: org_study_id