Compassionate Use of CORLUX® (Mifepristone) in the Treatment of Signs and Symptoms of Endogenous Cushing's Syndrome

NCT01371565 | Completed Phase 3 Results

• 1 other identifier: C1073-405
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 5

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.

Conditions

Cushing's Disease; Cushing's Syndrome

Keywords

Cushing's Disease; Cushing's Syndrome; Cushings; Pituitary; Ectopic ACTH secretion

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events

  Safety was assessed at all visits and adverse events were recorded.

  6 months

Study Arms (1)

mifepristone

EXPERIMENTAL

Drug: Mifepristone

Interventions

Mifepristone DRUG

mifepristone at doses from 300mg/day up to 1200mg/day

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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Corcept Therapeutics: lead

Study Sites (5)

The Center for Diabetes and Endocrine Care

Hollywood, Florida, 33021, United States

Location

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States

Location

University of Michigan Medical Center

Ann Arbor, Michigan, 48109, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

The Ohio State University, Division of Endocrinology Diabetes and Metabolism

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Pituitary ACTH Hypersecretion; Cushing Syndrome; Pituitary Diseases; ACTH Syndrome, Ectopic

Interventions

Mifepristone; Corlux

Condition Hierarchy (Ancestors)

Hyperpituitarism; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Adrenocortical Hyperfunction; Adrenal Gland Diseases; Paraneoplastic Endocrine Syndromes; Paraneoplastic Syndromes; Neoplasms

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, M.D.

  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: June 7, 2011
• First Posted: June 13, 2011
• Study Start: November 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: September 1, 2012
• Last Updated: March 18, 2014
• Results First Posted: November 20, 2013

Record last verified: 2014-02

Locations

US (5)