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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Corcept Therapeutics
ClinicalTrials.gov Identifier:
NCT00936741
First received: July 9, 2009
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Cushing's Syndrome
Drug: mifepristone
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Corcept Therapeutics:

Primary Outcome Measures:
  • Number of Participants With Adverse Events [ Time Frame: Up to three years. ] [ Designated as safety issue: No ]
    Subjects who received at least one dose of mifepristone were included in the safety analysis.


Secondary Outcome Measures:
  • 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 [ Time Frame: Up to three years. ] [ Designated as safety issue: No ]

    The mean Investigator's rating of the change in subject's signs and symptoms of Cushing's syndrome from Baseline (Entry into C1073-415) to Endpoint on the Physician's Global Assessment of Disease Severity was ranked on a 9-point scale (9 = much worse, 7 = worse, 5 = no change, 3 = better, 1 = much better). Higher scores indicate more severe illness. Scoring was done at all visits except the 6 Week Follow-up visit; the final visit result (Endpoint) is reported here.

    The instruction was "Rate the change in the subject's signs and symptoms of Cushing's from Baseline (1 = much better to 9 = much worse)".



Enrollment: 30
Study Start Date: July 2009
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mifepristone
Mifepristone 300mg to 1200mg once daily
Drug: mifepristone
Mifepristone 300 mg to 1200 mg once daily
Other Name: CORLUX

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00936741

Locations
United States, Alabama
University of Alabama at Birmingham School of Medicine
Birmingham, Alabama, United States, 35294
United States, California
AMCR Institute Inc.
Escondido, California, United States, 92026
Stanford University Medical Center
Stanford, California, United States, 94305-5826
United States, Florida
The Center for Diabetes and Endocrine Care
Hollywood, Florida, United States, 33021
United States, Illinois
Northwestern University Feinberg Medical; Division of Endocrinology, Metabolism & Molecular Medicine
Chicago, Illinois, United States, 60611
United States, Maryland
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
University of Michigan Medical Center
Ann Arbor, Michigan, United States, 48109
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
United States, Ohio
Cleveland Clinic Foundation; Dept of Endocrinology, Diabetes & Metabolism
Cleveland, Ohio, United States, 44195
United States, Oklahoma
Oklahoma Diabetes Center
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Oregon Health Sciences University
Portland, Oregon, United States, 97239
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390-8857
United States, Wisconsin
Endocrinology Center at Community Medical Commons
Menomonee Falls, Wisconsin, United States, 53051
Sponsors and Collaborators
Corcept Therapeutics
Investigators
Study Director: Coleman Gross, MD Corcept Therapeutics
  More Information

Additional Information:
No publications provided

Responsible Party: Corcept Therapeutics
ClinicalTrials.gov Identifier: NCT00936741     History of Changes
Other Study ID Numbers: C-1073-415
Study First Received: July 9, 2009
Results First Received: September 18, 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
Cushing Syndrome
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
Ectopic ACTH Secretion

Additional relevant MeSH terms:
Cushing Syndrome
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases
Adrenocorticotropic Hormone
Mifepristone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents
Abortifacient Agents, Steroidal
Abortifacient Agents

ClinicalTrials.gov processed this record on April 15, 2014