EUCTR2014-000162-22-DE进行中（未招募）1 期
Prospective, single arm, open-label, multicenter, international study to assess the effects of metyrapone in patients with endogenous Cushing’s syndrome during a 12-week treatment period followed by an extension period of 24 weeks. - PROMPT
aboratoire HRA Pharma0 个研究点目标入组 70 人开始时间: 2014年10月30日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 70
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. Any men and women = 18 years
- •2.Patients with endogenous Cushing’s syndrome for whom the following criteria apply:
- •Newly diagnosed Cushing’s disease patients who are unsuitable for early surgery or wish to defer surgery;
- •Or recurrent or persistent Cushing’s disease after pituitary surgery;
- •Or patients with ectopic ACTH syndrome either occult or after surgery failure or inoperable or metastatic;
- •Or patients with Cushing’s syndrome from adrenal causes who are unsuitable for early surgery or wish to defer surgery;
- •3.For patients receiving previous medical therapy, the following wash-out periods should be completed:
- •Steroidogenesis inhibitors excluding mitotane (e.g. ketoconazole), 1 week
- •Dopamine agonists (bromocriptine, cabergoline), 4 weeks
- •Pasireotide S/C, 1 week
- •Pasireotide LAR (formulated for once-monthly dosing), 12 weeks
- •Mifepristone, 4 weeks
- •4.UFC = 1.5-fold ULN on each of the three 24-hour urinary sampling measurements (after previous treatment withdrawal if applicable or in non-treated patients) provided that the diagnosis of Cushing’s syndrome has been confirmed. Urine collections for UFC measurements will be done within 5 weeks before the baseline visit.
- •5.Female patients should not be at risk of pregnancy (could be included if sterilized, post-menopausal, sexually inactive or using methods of contraception throughout the study)
- •6.Able and willing to give voluntary, written informed consent to participate in the study
- •7.Agree to observe all study requirements and be available for all planned study visits
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 65
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •1.Pseudo Cushing’s syndrome
- •2.Cyclic Cushing’s syndrome defined by at least one normal UFC value among at least three 24-hour urinary sampling measurements over the previous 2 months
- •3.Advanced adrenocortical carcinoma or ectopic ACTH secretion (EAS) secondary to a small cell lung carcinoma
- •4. Life expectancy less than 3 months
- •5. Pituitary or adrenal surgery or pituitary irradiation or surgery of the ACTH-secreting ectopic tumor or bilateral adrenalectomy planned before the week 12 visit
- •6.Pituitary irradiation within the previous 5 years (for Cushing’s disease patients)
- •7. Enlarged pituitary adenoma (greater than 1 cm in vertical diameter and leaving less than 2 mm from the chiasma) or compression of the optic chiasma on the pituitary MRI for patients with Cushing’s disease
- •8. Severe uncontrolled hypertension (>180/110 mmHg) despite anti-hypertensive therapy (for otherwise eligible patients, blood pressure medication may be adjusted to meet this criterion)
- •9. Severe hypokalemia (< 2.5 mmol/L) despite corrective measures
- •10. White blood cell count <3 milliard /L; hemoglobin <10 g/dL; platelets <100 milliard/L
- •11. Any other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that in the judgment of the investigator, would present excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
- •12. Pregnant or positive pregnancy test at entrance or breast-feeding women
- •13. Current alcohol or drug abuse
- •14. Acute or chronic severe uncontrolled infections
- •15. Known hypersensitivity to metyrapone or to any of its excipients namely glycerol, disodium edentate, sodium hydroxide and phosphoric acid
- •16.Patients with mitotane (Lysodren®) plasma concentration > 3 mg/L
- •17.Participation in another treatment study or receiving any investigational treatment (drug, biological agent or device) within 30 days
- •18.Prohibited treatments
研究者
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