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Clinical Trials/EUCTR2013-002133-37-DE
EUCTR2013-002133-37-DE
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

Cortendo AB0 sites90 target enrollmentJune 12, 2014
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ConditionsEndogenous Cushing's syndrome (CS) or Cushing's diseaseMedDRA version: 19.1Level: LLTClassification code 10011657Term: Cushings syndromeSystem Organ Class: 100000004860Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Endogenous Cushing's syndrome (CS) or Cushing's disease
Sponsor
Cortendo AB
Enrollment
90
Status
Active, not recruiting
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 12, 2014
End Date
TBD
Last Updated
7 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. Male or female \=18 years of age
  • •2\. Able to provide written informed consent prior to any study proc. being performed; eligible subjects must be able to understand the informed consent form prior to inclusion into the study.
  • •3\. Conf. diagnosis of newly diagnosed, persistent or recurrent Cushing’s disease (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 CRH secretion
  • •\- Adrenal\-dependent CS (i.e. adrenal adenoma (NOT carcinoma), adrenal hyperplasia, etc.)
  • •\- Etiology unknown.
  • •In the absence of pathological or post\-surgical confirmation of the diagnosis of CD (i.e. documented adrenal insufficiency post\-adenomectomy or hypophysectomy, which will be considered diagnostic). The following historical evidence will be considered satisfactory to establish the diagnosis of CD:
  • •Plasma corticotropin (ACTH) level \>20 pg/mL (4\.5 pmol/L) or greater (Note: ACTH \=5 pg/mL (1\.1 pmol/L) and \=20 pg/mL will generally suffice only if accompanied by either a positive CRH stimulation test or Dexamethasone Suppression Test (DST) or combined CRH\-DST) PLUS one of the diagnostic strategies described below based on pituitary magnetic resonance imaging (MRI)/computed tomography (CT) findings (Note: pituitary imaging preceding the original diagnosis is a requirement for eligibility):
  • •For tumors \=6 mm by imaging:

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. Subj. with early stage prostate cancer undergoing no treatment due to low grade potential may be enrolled
  • •7\. Clinical or radiol. signs of compression of the optic chiasm.
  • •8\. Major surgery within 1 month prior to enrollment
  • •9\. Subjects with clinically significant abnormality in 12\-lead ECGs during the Screening Phase needing medical intervention.
  • •10\. Subjects with QTc interval of \>470 msec during the Screening Phase

Outcomes

Primary Outcomes

Not specified

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