A Study of the Efficacy and Safety of CORLUX in the Treatment of Endogenous Cushing's Syndrome

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00569582
• Date of registration: 05/12/2007
• Prospective Registration: No
• Primary sponsor: Corcept Therapeutics
• Public title: A Study of the Efficacy and Safety of CORLUX in the Treatment of Endogenous Cushing's Syndrome SEISMIC
• Scientific title: An Open-label Study of the Efficacy and Safety of CORLUX (Mifepristone) in the Treatment of the Signs and Symptoms of Endogenous Cushing's Syndrome
• Date of first enrolment: December 2007
• Target sample size: 50
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00569582
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

United States

Contacts

• Name: Coleman Gross
• Affiliation: Corcept Therapeutics

Key inclusion & exclusion criteria

Inclusion Criteria:

Individuals eligible for enrollment into this study are adult male and non-pregnant female
adult patients who:

- Are at least 18 years of age

- Have a confirmed diagnosis of endogenous hypercortisolemia caused by ACTH dependent or
ACTH independent etiologies, including

1. Cushing's Disease (that has recurred after primary pituitary surgery, or has
failed pituitary surgery, or has been treated with radiation therapy to the
pituitary, or is not treatable with surgery, or exists in patients who are not
candidates for surgery, and is confirmed by documentation of ACTH
immuno-reactivity on a pathological evaluation of pituitary tissue from a
previous surgical specimen or IPSS with a central-to-peripheral gradient (ratio)
of >2 before or >3 after CRH administration).

2. Ectopic ACTH

3. Ectopic CRF secretion

4. Adrenal adenoma

5. Adrenal carcinoma

6. Adrenal autonomy

- Require medical treatment of hypercortisolemia

- Have diabetes mellitus type 2 or glucose intolerance AND/OR have hypertension *Note:
To be eligible for inclusion subjects must have documented evidence of persistent
endogenous 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.

- Receive PPARgamma agonist drugs (e.g. pioglitazone, rosiglitazone) within 4 months of
Baseline (Day 1).

- Postmenopausal women with an intact uterus who have experienced unexplained vaginal
bleeding within 12 months of Screening are excluded.

- Have renal failure as defined by a serum creatinine of =2.2 mg/dL.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cushing's Syndrome

Intervention(s)

Drug: mifepristone

Primary Outcome(s)

Decrease in Diastolic Blood Pressure. [Time Frame: Baseline to Week 24]

Improvement in Diabetes and/or Glucose Intolerance. [Time Frame: Baseline to Week 24]

Secondary ID(s)

C-1073-400

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 28/05/2012
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00569582