EUCTR2013-002133-37-ES
Active, not recruiting
Phase 1
An Open Label Study to Assess the Safety and Efficiacy of COR-003 (2S,4R- Ketoconazole) in the Treatment of Endogenous Cushing's Syndrome (CS) Estudio abierto para evaluar la seguridad y la eficacia del producto COR-003 (2S, 4R-ketoconazol) en el tratamiento del síndrome de Cushing endógeno (SC)
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Endogenous Cushing's syndrome (CS)
- 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
- •\-Male or female \> or \=18 year of age
- •\-Confirmed diagnosis of persistent or recurrent CS (with or without therapy) or newly diagnosed disease, if they are not candidates for surgery. CS will be defined according to the criteria in the guidelines for diagnosis of CS (Nieman 2008\). Previous medical records will be collected and used to support the diagnosis. The diagnostic criteria for appropriateness of inclusion of each subject into the study will be reviewed by the Medical Monitor. Diagnosis of the disease will be based on the association of clinical features of endogenous CS, review of past medication history, excluding exogenous sources of glucocorticoids, and abnormal values from two of the three following tests: (see protocol)
- •\-Previously irradiated subjects will be allowed as long as the radiation treatment occurred \> 4 years ago and they do not evidence for improvement in their underlying Cushings?s disease for 6 months. The total number of previously irradiated subjects enolled in this study will not exceed 10\.
- •\-Subjects who refuse surgery or in whom surgery will be delayed beyond the projected duration of this study will be permitted to participate.
- •\-Confirmed diagnosis of persistent or recurrent endogenous hypercortisolemia as defined by UFC concentrations on repeated determinations (described in Inclusion \#2\) caused by either ACTH\-dependent or ACTH\-independent etiologies.
- •6\.Subjects whose CS is due to Cushing?s disease without adenomas based on a pituitary magnetic resonance imaging (MRI) scan may be enrolled as long as biochemical criteria in Inclusion Criteria \#5 are met.
- •7\.Subjects on treatment for CS for whom treatment has been inadequate or not well tolerated must agree to the following minimum washout periods as determined by the nature of their treatment before baseline assessments are performed for participation in this study: (see protocol)
- •8\.Subjects on megasterol acetate (medroxyprogesterone acetate) must agree to a wash out of \> or \=6 weeks prior to receiving the first dose of the study medication.
- •9\.Subjects with impaired fasting glucose, diabetes and/or hypertension or any other manifestation of Cushing?s syndrome as long as they do not exceed exclusion criteria cited in Section 5\.2 and meet biochemical inclusion criteria for the diagnosis of Cushing?s Syndrome
- •10\.Female subjects should be either post\-menopausal, surgically sterile, or women of child\-bearing potential (WOCP) with a negative serum beta human chorionic gonadotropin (?hCG) pregnancy test prior to entering the study and who agree to use an acceptable method of contraception, for the duration of the study. Condoms will be considered an acceptable form of contraceptive.
Exclusion Criteria
- •1\.De novo Cushing´s disease AND a candidate for pituitary surgery
- •2\.Subjects treated with radiation within the previous 4 years or \>4 years and with evidence of improvement in their disease within 6 months
- •3\.Subjects who have been treated with mitotane within 6 months of screening or have levels exceeding 5 micro/mL
- •4\.Characteristics of pseudo\-CS
- •5\.Subjects with adrenal carcinoma
- •6\.Body habitus preventing repeated venipuncture as required by protocol
- •7\.Subject is currently in another study or has received any investigational treatment within 30 days or 5 half lives of screening, whichever is longer
- •8\.Male and female subjects with QTc interval of \>470 msec
- •9\.History of Torsades des Pointes or ventricular tachycardia or ventricular fibrillation or history of prolonged QT syndrome (including family history) or use of medications resulting in QT/QTc prolongation or hypokalemia \<3\.0 meq/L
- •10\.Subjects with a non\-endogenous source of hypercortisolemia such as exogenous source of glucocorticoids or therapeutic use of ACTH
Outcomes
Primary Outcomes
Not specified
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