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

Purpose

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.

Condition	Intervention	Phase
Cushing's Disease Cushing's Syndrome	Drug: Mifepristone	Phase 3


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Compassionate Use Protocol for the Administration of CORLUX® (Mifepristone) in the Treatment of the Signs and Symptoms of Endogenous Cushing's Syndrome

Resource links provided by NLM:

Genetics Home Reference related topics: Cushing disease familial isolated pituitary adenoma

MedlinePlus related topics: Cushing's Syndrome

Drug Information available for: Mifepristone

Genetic and Rare Diseases Information Center resources: Cushing's Syndrome Cushing Disease Hyperadrenalism

U.S. FDA Resources

Further study details as provided by Corcept Therapeutics:

Primary Outcome Measures:

Number of Participants With Adverse Events [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Safety was assessed at all visits and adverse events were recorded.


Enrollment:	4
Study Start Date:	November 2010
Study Completion Date:	September 2012
Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: mifepristone	Drug: Mifepristone mifepristone at doses from 300mg/day up to 1200mg/day Other Name: CORLUX®

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01371565

Locations


United States, Florida
The Center for Diabetes and Endocrine Care
Hollywood, Florida, United States, 33021
United States, Maryland
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
United States, Michigan
University of Michigan Medical Center
Ann Arbor, Michigan, United States, 48109
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
The Ohio State University, Division of Endocrinology Diabetes and Metabolism
Columbus, Ohio, United States, 43210

Sponsors and Collaborators

Corcept Therapeutics

Investigators


Study Director:	Coleman Gross, M.D.	Corcept Therapeutics

More Information


Responsible Party:	Corcept Therapeutics
ClinicalTrials.gov Identifier:	NCT01371565 History of Changes
Other Study ID Numbers:	C1073-405
Study First Received:	June 7, 2011
Results First Received:	September 19, 2013
Last Updated:	February 19, 2014
Health Authority:	United States: Food and Drug Administration

Keywords provided by Corcept Therapeutics:


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

Additional relevant MeSH terms:


Syndrome Signs and Symptoms Cushing Syndrome Pituitary ACTH Hypersecretion ACTH-Secreting Pituitary Adenoma Disease Pathologic Processes Adrenocortical Hyperfunction Adrenal Gland Diseases Endocrine System Diseases Hyperpituitarism Pituitary Diseases Hypothalamic Diseases Brain Diseases Central Nervous System Diseases	Nervous System Diseases Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Pituitary Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Mifepristone Abortifacient Agents, Steroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs Contraceptives, Oral, Synthetic Contraceptives, Oral

ClinicalTrials.gov processed this record on September 27, 2016