EUCTR2006-004111-22-GB进行中（未招募）1 期
A randomized, double-blind study to assess the safety and efficacy of different dose levels of Pasireotide (SOM230) s.c. over a 6 month treatment period in patients with de novo, persistent or recurrent 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
- 146
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
- •Male or female patients aged 18 years or greater
- •Patients with confirmed diagnosis of ACTH-dependent Cushing’s disease, as evidenced by (1) mean UFC from two 24-hour urinary collections at least 1.5 times the upper limit of the laboratory normal range collected within 2 weeks; (2) morning plasma ACTH within the normal or above normal range; (3) either MRI confirmation of pituitary macroadenoma (greater than or equal to 1 cm) or inferior petrosal sinus gradient >3 after corticotrophin-releasing hormone (CRH) or for those patients with a microadenoma (tumor less than 1cm)*
- •*if IPSS had previously been performed without CRH (eg. with DDAVP), then a central to peripheral pre-stimulation gradien >2 is required. If IPSS had not previously been performed, IPSS with CRH stimulation is required.
- •Patients with de novo Cushing’s disease can be included only if they are not considered candidates for pituitary surgery (e.g. poor surgery candidates, surgically unapproachable tumors, patients who refuse to have surgical treatment)
- •Confirmatory testing prior to IPSS (low-dose dexamethasone suppression testing or dexamethasone-CRH testing) has to be performed for patients with UFC = 3.0 X ULN and a pituitary microadenoma in order to exclude possible pseudo-Cushing’s
- •Karnofsky performance status =60 (i.e. requires occasional assistance, but is able to care for most of his personal needs)
- •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: 4 weeks
- •- Octreotide LAR and Lanreotide autogel: 8 weeks
- •- Lanreotide SR: 4 weeks
- •- Octreotide – immediate release formulation: 1 week
- •Patients with a known history of impaired fasting glucose or Diabetes Mellitus (DM) may be included, however blood glucose and antidiabetic treatment must be monitored closely throughout the trial and adjusted as necessary
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients who:
- •have received pituitary irradiation within the last two years prior to visit 1, as the onset time of the radiation effects can not be determined
- •were treated with mitotane during the last 6 months
- •with compression of the optic chiasm causing any visual field defect
- •with Cushing’s syndrome due to ectopic ACTH secretion
- •with hypercortisolism secondary to adrenal tumors or Nodular (primary) bilateral adrenal hyperplasia
- •have a known inherited syndrome as the cause for hormone over secretion (i.e. Carney Complex, McCune-Albright syndrome, MEN-1)
- •with a diagnosis of glucocorticoid-remedial aldosteronism (GRA)
- •are hypothyroid and not on adequate replacement therapy
- •have undergone major surgery within 1 month
- •with symptomatic cholelithiasis
- •Diabetic patients on antidiabetic medications whose fasting blood glucose is poorly controlled as evidenced by HbA1c >8%
- •with abnormal coagulation (PT or PTT elevated by 30% above normal limits)
- •receiving anticoagulants that affect PT or PTT
- •have congestive heart failure (NYHA Class III or IV), unstable angina, sustained ventricular tachycardia, symptomatic bradycardia, advanced heart block, history of acute MI less than one year prior to study entry or clinically significant impairment in cardiovascular function
- •Patients with risk factors for torsade de pointes, i.e. patients with a
- •baseline QTc >480 ms, hypokalemia, family history of long QT
- •syndrome, and concomitant medications known to prolong QT interval
- •Patients with liver disease such as cirrhosis, chronic active hepatitis, or
- •chronic persistent hepatitis, or patients with ALT/AST more than 2 X
- •ULN, serum creatinine >2.0 X ULN, serum bilirubin >2.0 X ULN, serum
- •albumin < 0.67 X LLN
- •Patients with liver disease such as cirrhosis, chronic active hepatitis, or chronic persistent hepatitis, or patients with ALT/AST more than 2 X ULN, serum creatinine >2.0 X ULN, serum bilirubin >2.0 X ULN, serum albumin >0.67 X ULN
- •Patients with WBC <3 X 109/L; Hgb •Patients who have any current or prior medical condition that can interfere with the conduct of the study or the evaluation of its results in the opinion of the investigator or the sponsor’s medical monitor
- •Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method for birth control. Female patients must use barrier contraception with condoms. If oral contraception is used, the patient must have been practicing this method for at least two months prior to enrollment and must agree to continue the oral contraceptive throughout the course of the study and for one month after the last dose of study drug. Male patients who are sexually active are required to use condoms during the study and for 1 month afterwards
- •History of immunocompromise. An HIV test will not be required, however, previous medical history will be reviewed
- •Patients with a history of alcohol or drug abuse in the 6 month period prior to
- •receiving pasireotide
- •Patients who have given a blood donation within 2 months before receiving pasireotide
- •Patients who have participated in any clinical investigation with an investigational drug within 1 month prior to dosing and patients who have previously been treated with pasireotide
- •Known hypersensitivity to somatostatin analogues
- •Patients with the presence of active or suspected acute or chronic uncontrolled infection
- •Patients with a history of non-compliance to med
研究者
相似试验
进行中（未招募）
不适用
A randomized, double-blind study to assess the safety and efficacy of different dose levels of Pasireotide (SOM230) s.c. over a 6 month treatment period in patients with de novo, persistent or recurrent Cushing’s diseaseEUCTR2006-004111-22-GRovartis Pharma Services AG146
进行中（未招募）
不适用
A randomized, double-blind study to assess the safety and efficacy of different dose levels of Pasireotide (SOM230) s.c. over a 6 month treatment period in patients with de novo, persistent or recurrent Cushing’s diseaseCushing’s disease is rare disease that is caused by an adrenocorticotropic hormone (ACTH) secreting pituitary adenoma. The elevated ACTH secreted by these tumors stimulates the adrenal glands to produce excess cortisol, leading to the subsequent development of the clinical signs and symptoms of hypercortisolism. Cushing's disease is associated with severe morbidity and premature mortality and most commonly affects adults aged 20-50, primarily femalesMedDRA version: 8.1Level: LLTClassification code 10011651Term: Cushing's diseaseEUCTR2006-004111-22-DEovartis Pharma Services AG100
进行中（未招募）
不适用
A randomized, double-blind study to assess the safety and efficacy of different dose levels of Pasireotide (SOM230) s.c. over a 6 month treatment period in patients with de novo, persistent or recurrent Cushing’s diseaseMedDRA version: 8.1Level: LLTClassification code 10011651Term: Cushing's diseaseCushing’s disease is rare disease that is caused by an adrenocorticotropic hormone (ACTH) secreting pituitary adenoma. The elevated ACTH secreted by these tumors stimulates the adrenal glands to produce excess cortisol, leading to the subsequent development of the clinical signs and symptoms of hypercortisolism. Cushing's disease is associated with severe morbidity and premature mortality and most commonly affects adults aged 20-50, primarily femalesEUCTR2006-004111-22-DKovartis Pharma Services AG146
进行中（未招募）
不适用
//de novo or persistent/recurrent Cushing diseaseMedDRA version: 14.1Level: PTClassification code 10011652Term: Cushing's syndromeSystem Organ Class: 10014698 - Endocrine disordersEUCTR2006-004111-22-ITOVARTIS FARMA100
进行中（未招募）
1 期
A randomized, double-blind study to assess the safety and efficacy of different dose levels of Pasireotide (SOM230) s.c. over a 6 month treatment period in patients with de novo, persistent or recurrent Cushing’s diseaseCushing’s disease is rare disease that is caused by an adrenocorticotropic hormone (ACTH) secreting pituitary adenoma. The elevated ACTH secreted by these tumors stimulates the adrenal glands to produce excess cortisol, leading to the subsequent development of the clinical signs and symptoms of hypercortisolism. Cushing's disease is associated with severe morbidity and premature mortality and most commonly affects adults aged 20-50, primarily femalesMedDRA version: 14.1Level: LLTClassification code 10011651Term: Cushing's diseaseSystem Organ Class: 10014698 - Endocrine disordersEUCTR2006-004111-22-BEovartis Pharma Services AG146