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

NCT00936741 | Completed Phase 3 Results

• 1 other identifier: C-1073-415
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 15

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• 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

  Up to three years.

Study Arms (1)

Mifepristone

EXPERIMENTAL

Mifepristone 300mg to 1200mg once daily

Drug: mifepristone

Interventions

mifepristone DRUG

Mifepristone 300 mg to 1200 mg once daily

Also known as: CORLUX

Mifepristone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Corcept Therapeutics: lead

Study Sites (15)

University of Alabama at Birmingham School of Medicine

Birmingham, Alabama, 35294, United States

Location

AMCR Institute Inc.

Escondido, California, 92026, United States

Location

Stanford University Medical Center

Stanford, California, 94305-5826, United States

Location

The Center for Diabetes and Endocrine Care

Hollywood, Florida, 33021, United States

Location

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

Chicago, Illinois, 60611, United States

Location

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of Michigan Medical Center

Ann Arbor, Michigan, 48109, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

Cleveland Clinic Foundation; Dept of Endocrinology, Diabetes & Metabolism

Cleveland, Ohio, 44195, United States

Location

Oklahoma Diabetes Center

Oklahoma City, Oklahoma, 73104, United States

Location

Oregon Health Sciences University

Portland, Oregon, 97239, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390-8857, United States

Location

Endocrinology Center at Community Medical Commons

Menomonee Falls, Wisconsin, 53051, United States

Location

Related Publications (2)

• 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.

  PMID: 26507877 DERIVED

• 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.

  PMID: 25013998 DERIVED

Related Links

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

MeSH Terms

Conditions

Cushing Syndrome; Pituitary ACTH Hypersecretion; Pituitary Diseases; Choristoma; ACTH Syndrome, Ectopic; Adrenal Cortex Neoplasms; Hirsutism

Interventions

Mifepristone; Corlux

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases; Hyperpituitarism; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Paraneoplastic Endocrine Syndromes; Paraneoplastic Syndromes; Neoplasms; Adrenal Gland Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Adrenal Cortex Diseases; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Virilism; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Medical Director
• Organization: Corcept Therapeutics

info@corcept.com

650-327-3270

Study Officials

• Coleman Gross, MD

  Corcept Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2009
• First Posted: July 10, 2009
• Study Start: July 1, 2009
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: April 2, 2014
• Results First Posted: April 2, 2014

Record last verified: 2014-02

Locations

US (15)