A Study of the Efficacy and Safety of CORLUX in the Treatment of Endogenous Cushing's Syndrome - NCT00569582-53051 (Clinical Trial 193995)
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| City: |
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Menomonee Falls |
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State:
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WI |
| Zip Code: |
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53051 |
| Conditions: |
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Cushing's Syndrome |
| Purpose: |
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Patients will receive Corlux (mifepristone) daily for up to 24 weeks. Assessments of the
signs and symptoms of Cushing's syndrome will be obtained.
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| Study summary: |
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Cushing's syndrome is a relatively rare disorder caused by prolonged exposure to high levels
of the glucocorticoid hormone cortisol. Cushing's syndrome may result from elevated
endogenous or exogenous sources of cortisol. Endogenous Cushing's syndrome resulting from
cortisol overproduction by the adrenal glands is the subject of this protocol. Patients
with exogenous Cushing's syndrome, which develops as a side effect of chronic administration
of high doses of glucocorticoids, are not eligible for enrollment in this study.
This will evaluate the safety and efficacy of mifepristone for treatment of the signs and
symptoms of hypercortisolemia in patients with endogenous Cushing's syndrome from
ACTH-dependent or adrenal disorders.
The study will enroll subjects for whom the investigator has determined that medical
treatment of endogenous hypercortisolemia is needed. Medical treatment may be intended to
treat the effects of persistent or recurrent hypercortisolemia after surgery and/or
radiation for Cushing's syndrome, to bridge the period of time for radiation to become
effective, or when surgery is not feasible. |
| Criteria: |
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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. |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 4, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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