EUCTR2010-024165-44-CZ进行中（未招募）不适用
An open-label, multi-center, expanded access study of pasireotide s.c. in patients with Cushing’s disease (Seascape) - Seascape
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
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
- •Patients eligible for inclusion in this study have to meet all of the following criteria:
- •1.Written informed consent obtained prior to any screening procedures
- •2.Male or female patients aged 18 years or greater
- •3.Patients with confirmed diagnosis of Cushing’s disease as evidenced by
- •mean urinary free cortisol of three 24-hour urine samples collected during the 2-week screening period above the upper limit of the laboratory normal range
- •morning plasma ACTH within the normal or above normal range
- •either MRI confirmation of pituitary adenoma (greater than or equal to 0.6 cm), or inferior petrosal sinus gradient >3 after CRH stimulation for those patients with a microadenoma less than 0.6 cm*, or for patients who have had prior pituitary surgery, histopathology confirming an ACTH staining adenoma.
- •(* if IPSS had previously been performed without CRH (e.g.with DDAVP), then a central to peripheral pre-stimulation gradient > 2 is required. If IPSS had not previously been performed, IPSS with CRH stimulation is required)
- •4.Patients with de novo Cushing’s disease must not be considered as candidates for pituitary surgery (i.e. poor surgical candidates, surgically unapproachable tumors, patients with no visible pituitary tumor, patients who refuse to have surgical treatment)
- •5.Karnofsky performance status >60 (i.e. requires occasional assistance, but is able to care for most of this personal needs)
- •6.For patients on previous medical treatment for Cushing’s disease the following washout periods must be completed before screening assessments are performed
- •Inhibitors of steroidogenesis (ketoconazole, metyrapone, rosiglitazone): 1 week
- •Dopamine agonists (bromocriptine, cabergoline): 4 weeks
- •Mitotane: 6 months
- •Octreotide LAR and Lanreotide autogel: 8 weeks
- •Lanreotide SR: 4 weeks
- •Octreotide (immediate release formulation): 1 week
- •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 190
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Patients eligible for this study must not meet any of the following criteria:
- •1.Radiotherapy of the pituitary <4 weeks before screening or patient who has not recovered from side effects
- •2.Patients with compression of the optic chiasm causing acute clinically significant visual field defect
- •3.Patients with Cushing’s syndrome due to ectopic ACTH secretion
- •4.Patients with hypercortisolism secondary to adrenal tumors or nodular (primary) bilateral adrenal hyperplasia
- •5.Patients who have a known inherited syndrome as the cause for hormone over secretion (i.e. Carney Complex, McCune-Albright syndrome, MEN-1)
- •6.Patients with a diagnosis of glucocorticoid-remedial aldosteronism (GRA)
- •7.Patients who have undergone major surgery within 1 month prior to screening
- •8.Patients with known gallbladder or bile duct disease, acute or chronic pancreatitis (patients with asymptomatic cholelithiasis and asymptomatic bile duct dilation can be included)
- •9.Diabetic patients whose blood glucose is poorly controlled as evidenced by HbA1C >8%
- •10.Patients who have clinically significant impairment in cardiovascular function or are at risk thereof, as evidenced by
- •congestive heart failure (NYHA Class III or IV), unstable angina, sustained ventricular tachycardia, clinically significant bradycardia, high grade AV block, history of acute MI less than one year prior to study entry
- •QTcF >450 msec at screening
- •History of syncope or family history of idiopathic sudden death
- •Risk factors for Torsades de Pointes such as uncorrected hypokalemia, uncorrected hypomagnesemia, cardiac failure
- •Concomitant disease(s) that could prolong the QT interval such as autonomic neuropathy (caused by diabetes or Parkinson's disease), HIV,cirrhosis, uncontrolled hypothyroidism, concomitant medication(s) with known risk for TdPOther protocol-defined inclusion/exclusion criteria may apply
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