EUCTR2004-001483-51-GB进行中（未招募）不适用
A phase IA/II multicenter, dose-escalation study of oral AMN107 on a continuous daily dosing schedule in adult patients with Gleevec-resistant/intolerant CML in chronic or accelerated phase or blast crisis, relapsed/refractory Ph+ ALL and other hematological malignancies - NA
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
- 955
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 must have the following laboratory values:
- •Potassium = LLN (lower limit of normal) or correctable with supplements
- •Total calcium (corrected for serum albumin) = LLN or correctable with supplements
- •Magnesium = LLN or correctable with supplements
- •Phosphorus = LLN or correctable with supplements
- •ALT and AST = 2.5 x ULN or = 5.0 x ULN if considered due to tumor
- •Alkaline phosphatase = 2.5 x ULN
- •Serum bilirubin = 1.5 x ULN
- •Serum creatinine = 1.5 x ULN or 24-hour creatinine clearance ? 50 ml/min
- •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
- •Cytopathologically confirmed CNS infiltration
- •NB: in absence of suspicion of CNS involvement, lumbar puncture is not required
- •Impaired cardiac function, including any one of the following
- •LVEF < 45% as determined by MUGA scan or echocardiogram
- •Complete left bundle branch block
- •Use of a cardiac pacemaker
- •ST depression of > 1mm in 2 or more leads and/or T wave inversions in 2 or more contiguous leads
- •Congenital long QT syndrome
- •History of or presence of significant ventricular or atrial tachyarrhythmias
- •Clinically significant resting bradycardia (< 50 beats per minute)
- •QTc > 480 msec (> 450 msec in Phase II) screening ECG (using the QTcF formula)
- •Right bundle branch block plus left anterior hemiblock, bifascicular block
- •Myocardial infarction within 3 months prior to starting AMN107
- •Angina pectoris (unstable angina pectoris diagnosed or treated during the last 12 months in Phase II)
- •Other clinically significant heart disease (e.g., congestive heart failure, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen)
- •Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of AMN107 (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
- •Use of therapeutic warfarin.
- •Acute or chronic liver or renal disease considered unrelated to tumor
- •Other concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled diabetes, active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol
- •Treatment with any hematopoietic colony-stimulating growth factors (e.g., G-CSF, GM-CSF) = 1 week prior to starting study drug. Erythropoietin is allowed.
研究者
相似试验
进行中（未招募）
不适用
A phase IA/II multicenter, dose-escalation study of oral AMN107 on a continuous daily dosing schedule in adult patients with Gleevec (imatinib)-resistant/intolerant CML in chronic or accelerated phase or blast crisis, relapsed/refractory Ph+ ALL or other hematologic malignancies - NAEUCTR2004-001483-51-FIovartis Pharma AG955
进行中（未招募）
不适用
A phase IA/II multicenter, dose-escalation study of oral AMN107 on a continuous daily dosing schedule in adult patients with Gleevec (imatinib)-resistant/intolerant CML in chronic or accelerated phase or blast crisis, relapsed/refractory Ph+ ALL or other hematologic malignancies - NACML in chronic phase, accelerated phase or blast crisis, relapsed/refractory Ph+ ALL, systemic mastocytosis, or hypereosinophilic syndromeMedDRA version: 14.0Level: LLTClassification code 10009700Term: CMLSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2004-001483-51-SEovartis Pharma AG955
进行中（未招募）
不适用
A phase IA/II multicenter, dose-escalation study of oral AMN107 on a continuous daily dosing schedule in adult patients with Gleevec (imatinib)-resistant/intolerant CML in chronic or accelerated phase or blast crisis, relapsed/refractory Ph+ ALL or other hematologic malignancies - NACML in chronic phase, accelerated phase or blast crisis, relapsed/refractory Ph+ ALL, systemic mastocytosis, or hypereosinophilic syndromeEUCTR2004-001483-51-ATovartis Pharma Services AG269
进行中（未招募）
不适用
A phase IA/II multicenter, dose-escalation study of oral AMN107 on a continuous daily dosing schedule in adult patients with Gleevec-resistant CML in accelerated phase or blast crisis, relapsed/refractory Ph+ ALL, and other hematologic malignancies - NACML in chronic or accelerated phase or blast crisis, relapsed/refractory Ph+ ALL, and other hematologic malignanciesEUCTR2004-001483-51-DKovartis Pharma Services AG269
进行中（未招募）
不适用
A phase IA/II multicenter, dose-escalation study of oral AMN107 on a continuous daily dosing schedule in adult patients with Gleevec (imatinib)-resistant CML in accelerated phase or blast crisis, relapsed/refractory Ph+ ALL, and other hematologic malignancies.Treatment of adult patients with Gleevec (imatinib)-resistant CML in accelerated phase or blast crisis, relapsed/refractory Ph+ ALLand sistemic mastocytosis and idiopatic hypereosinophilic syndrome.MedDRA version: 14.1Level: PTClassification code 10009013Term: Chronic myeloid leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2004-001483-51-ITOVARTIS FARMA269