Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00936741
Other study ID # C-1073-415
Secondary ID
Status Completed
Phase Phase 3
First received July 9, 2009
Last updated February 19, 2014
Start date July 2009
Est. completion date September 2012

Study information

Verified date February 2014
Source Corcept Therapeutics
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date September 2012
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
mifepristone
Mifepristone 300 mg to 1200 mg once daily

Locations

Country Name City State
United States University of New Mexico Albuquerque New Mexico
United States University of Michigan Medical Center Ann Arbor Michigan
United States Sinai Hospital of Baltimore Baltimore Maryland
United States University of Alabama at Birmingham School of Medicine Birmingham Alabama
United States Massachusetts General Hospital Boston Massachusetts
United States Northwestern University Feinberg Medical; Division of Endocrinology, Metabolism & Molecular Medicine Chicago Illinois
United States Cleveland Clinic Foundation; Dept of Endocrinology, Diabetes & Metabolism Cleveland Ohio
United States University of Texas Southwestern Medical Center Dallas Texas
United States AMCR Institute Inc. Escondido California
United States The Center for Diabetes and Endocrine Care Hollywood Florida
United States University of Mississippi Medical Center Jackson Mississippi
United States Endocrinology Center at Community Medical Commons Menomonee Falls Wisconsin
United States Oklahoma Diabetes Center Oklahoma City Oklahoma
United States Oregon Health Sciences University Portland Oregon
United States Stanford University Medical Center Stanford California

Sponsors (1)

Lead Sponsor Collaborator
Corcept Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. No
Secondary 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 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)".
Up to three years. No
See also
  Status Clinical Trial Phase
Completed NCT02468193 - Study of Efficacy and Safety of Osilodrostat in Cushing's Syndrome Phase 2
Recruiting NCT00457587 - Preclinical Study Towards an Immunotherapy in Adrenocortical Carcinoma
Completed NCT00006278 - Study of Cushing's Syndrome Not Related to ACTH Production N/A
Completed NCT00361777 - Diagnostic Performance of Screening Tests for Cushing s Syndrome
Completed NCT03606408 - Roll-over Study in Patients With Endogenous Cushing's Syndrome for LCI699 Phase 2
Completed NCT02663609 - Retrospective Chart Review Study of Korlym for the Treatment of ACTH Independent Cushing's Syndrome
Recruiting NCT01504555 - Does Serum-DXM Increase Diagnostic Accuracy of the Overnight DXM Suppression Test in the Work-up of Cushing's Syndrome? Phase 3
Active, not recruiting NCT00004343 - Study of Hypercortisolism in Cushing's Syndrome and Stress-Induced Pseudo-Cushing's Syndrome N/A
Completed NCT02922257 - Biomarker Expression in Patients With ACTH-Dependent Cushing's Syndrome Before and After Surgery
Completed NCT01371565 - Compassionate Use of CORLUX® (Mifepristone) in the Treatment of Signs and Symptoms of Endogenous Cushing's Syndrome Phase 3
Terminated NCT00422201 - Prospective, Open-Label, Multicenter, International Study of Mifepristone for Symptomatic Treatment of Cushing's Syndrome Caused by Ectopic Adrenal Corticotrophin Hormone (ACTH) Secretion Phase 2
Completed NCT00001180 - Dose Response Relationship for Single Doses of Corticotropin Releasing Hormone (CRH) in Normal Volunteers and in Patients With Adrenal Insufficiency N/A
Completed NCT02804750 - Study to Evaluate CORT125134 in Participants With Cushing's Syndrome Phase 2
Recruiting NCT00004334 - Study of Depression, Peptides, and Steroids in Cushing's Syndrome N/A
Completed NCT03817840 - Novel Mediators of the Lipodystrophy and Metabolic Consequences of Cushing's Disease
Completed NCT01959711 - Randomized Clinical Trial of Posterior Retroperitoneoscopic Adrenalectomy Versus Lateral Laparoscopic Adrenalectomy Phase 4
Completed NCT05633953 - Osilodrostat for the Treatment of Non-Cushing's Disease Cushing's Syndrome
Completed NCT02889224 - In Vivo Study of Interactions Between the Endocannabinoid System and the Corticotropic Axis in Man N/A
Terminated NCT00796783 - A Study to Confirm Recurrent or Persistent Cushing's Syndrome in Patients With Signs or Symptoms of Hypercortisolemia N/A
Recruiting NCT02019706 - Prospective Evaluation of 68Ga-DOTATATE PET/CT, Octreotide and F-DOPA PET Imaging in Ectopic Cushing Syndrome Phase 2