An Extension Study of CORLUX in the Treatment of Endogenous Cushing's Syndrome
Condition: Cushing's Syndrome
MeSH terms: Cushing Syndrome; Syndrome
Intervention: mifepristone
Intervention description: Mifepristone 300 mg to 1200 mg once daily
Intervention MeSH terms: Mifepristone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cushing's Disease; Cushing's Syndrome; Cushings; 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; Cushing Syndrome; Ectopic ACTH Secretion

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.
    

Eligibility 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.