EUCTR2013-002133-37-BG
Active, not recruiting
Phase 1
An Open Label Study to Assess the Safety and Efficacy of COR—003 (2S, 4R-Ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Cortendo AB
- Enrollment
- 90
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Male or female \=18 years of age
- •2\. Able to provide written informed consent prior to any study
- •procedures being performed; eligible subjects must be able to
- •understand the informed consent form prior to inclusion into the study.
- •3\. Confirmed diagnosis of newly diagnosed, persistent or recurrent CD or endogenous CS of other etiology if subjects are not candidates for surgery or radiotherapy within the 18 months after enrollment.
- •Previous medical records will be collected and used to support the
- •diagnosis of CD or endogenous CS of other etiology, including the
- •following etiologies:
- •Ectopic ACTH secretion, i.e. ACTH not of pituitary origin
- •Ectopic corticotropin\-releasing hormone (CRH) secretion
Exclusion Criteria
- •1\. Subjects with Pseudo\-CS based on assessment of the Investigator
- •2\. Subjects with cyclic CS based on assessment of the investigator
- •3\. Subjects with a non\-endogenous source of hypercortisolism such as exogenous source of glucocorticoids or therapeutic use of ACTH.
- •4\. Known inherited syndrome as the cause of hypercortisolism, including but not limited to multiple endocrine neoplasia Type 1, McCune Albright Syndrome and Carney Complex
- •5\. Subjects with adrenal carcinoma
- •6\. History of malignancy, other than thyroid, early stage prostate,
- •squamous cell and basal cell carcinoma, within 3 years prior to the
- •Screening Phase. Subjects with history of such allowed carcinoma must have a life expectancy of \>18 months and must be considered medically stable. Subjects with early stage prostate cancer undergoing no treatment due to low grade potential may be enrolled
- •7\. Clinical or radiological signs of compression of the optic chiasm
- •8\. Major surgery within 1 month prior to enrollment
Outcomes
Primary Outcomes
Not specified
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