EUCTR2013-002170-49-GR进行中（未招募）1 期
A Phase II trial to assess the efficacy and safety ofpasireotide s.c. alone or in combination with cabergoline inpatients with Cushing’s disease
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 128
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
- •Inclusion criteria for Group 1:
- •1. Adult patients with confirmed diagnosis of ACTH-dependent Cushing’s disease
- •2. Patients with de novo Cushing’s disease can be included only if they are not considered candidates for pituitary surgery
- •3. Male or female patients aged 18 years or greater
- •4. Karnofsky performance status = 60 (i.e. requires occasional assistance, but is able to care for most of their personal
- •5.Patients on medical treatment for Cushing’s disease the following washout periods must be completed before
- •screening assessments are performed
- •6.Patients have been on pasireotide in the past but discontinued
- •because of lack of efficacy are also allowed to enter Group 1. Patients treated with pasireotide subcutaneously must have been discontinued from the treatment for at least 4 weeks before
- •screening. Patients treated with pasireotide LAR must have been
- •discontinued from the treatment for at least 12 weeks before screening.
- •7.Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, if they are using
- •highly effective methods of contraception during dosing and for 30 days after stopping study medication.
- •Inclusion criteria for Group 2:
- •1. Adult patients with confirmed diagnosis of ACTH-dependent
- •Cushing’s disease
- •2.Patients with de novo Cushing’s disease can be included only if
- •they are not considered candidates for pituitary surgery (e.g. poor surgical candidates, surgically unapproachable tumors, patients who refuse to have surgical treatment)
- •3.Patients currently treated with maximal tolerated doses of
- •pasireotide for at least 8 weeks at the time of screening but have not achieved biochemical control. These patients will
- •enter the study starting combination therapy.
- •4.Women of child-bearing potential, if they are using highly effective methods of contraception during dosing
- •and for 30 days after stopping study medication.
- •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 128
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion criteria for Group 1 and Group 2:
- •1. Patients with compression of the optic chiasm causing any visual field defect that requires surgical intervention
- •2. Diabetic patients with poor glycemic control as evidenced by HbA1c >8%
- •3. Patients with risk factors for torsade de pointes, i.e. patients with a baseline QTcF >450 ms in males, and > 460 ms in
- •females. hypokalemia, hypomagnesaemia, uncontrolled hypothyroidism, family history of long QT syndrome, or concomitant medications known to prolong QT interval.
- •4. Patients with clinically significant valvular disease.
- •5. Patients with Cushing’s syndrome due to ectopic ACTH secretion
- •6. Patients with hypercortisolism secondary to adrenal tumors or nodular (primary) bilateral adrenal hyperplasia
- •7. 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
- •8. Patients with liver disease such as cirrhosis, chronic active hepatitis, or chronic persistent hepatitis, or patients with ALT/AST > 2 X ULN, serum bilirubin >2.0 X ULN
- •9. Patients with serum creatinine >2.0 X ULN
- •10. Patients with WBC <3 X 10e9/L; Hb 90% < LLN; PLT <100 X 10e9/L
研究者
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