EUCTR2013-002133-37-ES进行中（未招募）1 期
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)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Cortendo AB
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •-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.
- •11.12-lead ECGs show no acute ischemia or clinically significant abnormality needing medical intervention
- •12.Ability to comprehend and comply with procedures
- •13.Agree to commit to participate in the current protocol
- •14.Subjects provide written informed consent prior to any study procedures being performed (all subjects should be able to understand the informed consent form and any other documents that subjects are required to read)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
排除标准
- •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
- •11.History of malignancy, other than thyroid, early stage prostate, squamous cell and basal cell carcinoma, within 3 years prior to the initial dose of the study medication. Subjects with history of carcinoma must have a life expectancy of >1 year and must be on stable doses of their specific therapies. Subjects with early stage prostate cancer undergoing no treatment due to low grade potential may be enrolled.
- •12.Diagnosis of HIV
- •13.History of persistent uncontrolled hypertension (>180/120 mmHg) despite medical intervention
- •14.Subjects with hypercholesterolemia who are on current atorvastatin or simvistatin and not willing or unable to change to alternative therapies as noted (pravastatin, fluvastatin, and rosuvastatin) with 2 weeks of study screening
- •15.Subjects with T2DM or with a history of hyperglycemic episodes requiring repeated, frequent hospitalizations specifically for diabetic management
- •16.Subjects with decreased renal function as defined by eGFR <40 mL/min/1.73 m2, using Modified Diet in Renal Disease (MDRD) equation for estimating renal function (eGFR).
- •17.Any other clinically significant medical condition, as determined by the Investigator that precludes enrollment and participation in the study through completion (for example, NYHA class III or IV congestive heart failure).
- •18.Known hepatic disease, other than mild to moderate hepatic steatosis consistent with fatty infiltration with ongoing sustained biochemical activity
- •19.History of recurrent gall stone attacks or pancreatitis
- •20.Positive for HbsAg or positive hepatitis C test
- •21.Liver function tests (LFT) must not be above the following cut-offs at screening: ALT and/or AST >3.0X ULN, GGT >2X ULN, and total bilirubin >2X ULN. If all LFTs are within normal limits (WNL) and total bilirubin is elevated, examination of direct and indirect bilirubin may be conducted. Subjects with indirect total bilirubin up to 3X ULN are presumed to have Gilbert?s syndrome and may be enrolled if all other LFTs are WNL.
- •22.History of documented clinically significant liver function abnormalities requiring drug
研究者
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