EUCTR2010-022403-22-IT进行中（未招募）1 期
A proof-of concept, open-label, forced titration, multicenter study to assess the safety/tolerability and efficacy of 10-weeks treatment of LCI699 in patients with Cushing’s disease
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 27
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
- 性别
- All
入选标准
- •1. Written informed consent must be obtained before any assessment is performed.2. Male or female patients aged 18 – 75 years.3. Patients must have confirmed Cushing’s Disease (including de novo patients) as evidenced by:a) UFC >1.5XULN (Mean value of three 24-hour urine samples collected within 14days);b) Morning plasma ACTH above 10 pg/mllower limit of normal;c) Confirmation of pituitary origin of excess ACTH by at least one of the following three:- History of MRI confirmation of pituitary adenoma (greater than or equal to 6mm)with positive dynamic test (e.g. CRH or high dose dexamethasone suppression test);- History of inferior petrosal sinus gradient >3 after CRH stimulation;- Prior pituitary surgery with histopathology confirming an ACTH staining adenoma; - Subjects are permitted to washout current drug therapy to meet these entry criteria if they have a known diagnosis of Cushing’s disease;4. For patients on medical treatment for Cushing’s disease the following washout periods must be completed before baseline efficacy assessments are performed:- Inhibitors of steroidogenesis (ketoconazole, metyrapone, rosiglitazone): 1 week; - Dopamine agonists (bromocriptine, cabergoline), PPAR-gamma agonists (rosiglitazone, pioglitazone): 4 weeks; - Octreotide LAR, Pasireotide LAR and Lanreotide autogel: 8 weeks; - Lanreotide SR: 4 weeks; - Octreotide and Pasireotide (immediate release formulation): 1 week; - Other experimental therapy: at least 5 half-lives.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Use of other investigational drugs at the time of enrollment, or within 30 days or 5 halflives of enrollment, whichever is longer; or longer if required by local regulations, and for any other limitation of participation in an investigational trial based on local regulations;2. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes;3. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases;4. Pregnant or nursing (lactating) women.;5. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they are also using two acceptable methods of contraception,- Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural amenorrhea with an appropriate clinical profile or six months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL; or have had surgical bilateral oophorectomy or tubal ligation at least six months ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential;6. Fertile males, defined as all males physiologically capable of conceiving offspring UNLESS the subject agrees to comply with two effective contraceptive methods comprising a barrier method for the entire duration of the study, up to the Study Completion visit, and refrain from fathering a child for at least three (3) months following the last study drug administration;7. Patients who have been treated with mitotane during the last 6 months prior to Visit 1;8. Patients with compression of the optic chiasm, in order to exclude patients with a tumor causing chiasmal compression requiring surgery;9. Patients who have a known inherited syndrome as the cause for hormone over secretion (i.e. Carney Complex, McCune-Albright syndrome, MEN-1, API);10. Patients with Cushing’s syndrome due to ectopic ACTH secretion or adrenal Cushing’s syndrome;11. Patients with pseudo-Cushing’s syndrome (for patients with a mean UFC < 3xULN further testing to rule out this condition will be required unless Cushing’s disease is confirmed by histopathology);12. Patients with renal impairment (estimated creatinine clearance < 60 ml/min by the MDRD formula), serum creatinine >2.0 X ULN;13. Patients who are not biochemically euthyroid;14. Patients who have undergone major surgery within 1 month prior to screening;15. Diabetic patients with poorly controlled diabetes as evidenced by HbA1c >9%;16. Patients who have congestive heart failure (NYHA Class III or IV), unstable angina,sustained ventricular tachycardia, clinically significant bradycardia, advanced heart block,history of acute MI less than one year prior to study entry or clinically significant impairment in cardiovascular function;17. Patients with liver disease such as cirrhosis, chronic active hepatitis, or chronic persistent hepatitis, or patients with ALT/AST more than 3 X ULN, serum bilirubin >2.0 X ULN; 18. Patients who have any current or prior medical condition that can interfere with the conduct of the study or the evaluation
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