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

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.

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Key information

Conditions

Cushing's Disease ACTH Syndrome, Ectopic Adrenal Gland Diseases Adrenocortical Hyperfunction Brain Diseases Central Nervous System Diseases Cushing Syndrome Cushing's Syndrome Endocrine System Diseases Hyperpituitarism Hypothalamic Diseases Neoplasms Nervous System Diseases Paraneoplastic Endocrine Syndromes Paraneoplastic Syndromes Pituitary ACTH Hypersecretion Pituitary Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Center for Diabetes and Endocrine Care, Hollywood, Florida, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

Mifepristone

Drug

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

Other names: CORLUX®

Primary outcomes

Number of Participants With Adverse Events

Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

Corcept Therapeutics

Industry

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2012
Study completion: 2012
First posted: Jun 13, 2011
Registry last updated: Mar 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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