EUCTR2004-001483-51-DK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 - NA
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 269
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 with a cytopathologically confirmed diagnosis of Ph+ ALL who are either relapsed after or refractory to standard therapy, or patients with CML in blast crisis, or CML patients in accelerated phase who are resistant to Gleevec®. Patients with Ph+ ALL who have minimal residual disease following stem cell transplantation may only be enrolled during the dose escalation portion of the study.
- •Following MTD determination, patients with a cytopathologically confirmed diagnosis of either CML in chronic phase who are Gleevec® resistant (Post text supplement 6), systemic mastocytosis or hypereosinophilic syndrome/ chronic eosinophilic leukemia. Patients with systemic mastocytosis or hypereosinophilia must have a clinical indication for treatment. HES/CEL patients should meet standard disease-definition criteria (Coutre and Gotlib 2004). Systemic mastocytosis patients should meet standard disease-definition criteria (Tefferi and Pardanani 2004)
- •Following MTD determination, patients with any of the eligible diseases who are Gleevec® intolerant (defined as patients who have discontinued Gleevec® therapy due to a grade 3 or 4 adverse event and have not had a major response to Gleevec®).
- •Age = 18 years old
- •WHO Performance Status of = 2 (Post-text suppl. 3)
- •Patients must have the following laboratory values:
- •Cytoreductive therapy with vincristine or cyclophosphamide is permitted up to 7 days prior to first administration of AMN107. Corticosteroids can be administered up to 48 hours prior to first administration of AMN107. Hydroxyurea is permitted as clinically indicated during the dose escalation phase
- •Potassium = LLN (lower limit of normal) or corrected to within normal limits with supplements prior to the first dose of study medication
- •Total calcium (corrected for serum albumin) = LLN or correctable with supplements
- •Magnesium = LLN or corrected to within normal limits with supplements prior to the first dose of study medication
- •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
- •Written informed consent
- •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% or below institutional lower limit of the normal range (which ever is higher) 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 > 450 msec on screening ECG (using the QTcF formula)
- •Right bundle branch block plus left anterior hemiblock, bifascicular block
- •Myocardial infarction within 12 months prior to starting AMN107
- •Unstable angina diagnosed or treated during the past 12 months
- •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.
- •Patients who are currently receiving treatment with any of the medications listed in Post-text supplement 4 (Amendment 8) and the treatment cannot be either discontinued or switched to a different medication prior to starting study drug. The medications listed in Post-text supplement 4 (Amendment 8) have the potential to prolong the QT interval or are CYP3A4 inhibitors.
- •Patients who have received chemotherapy = 1 week (6 weeks for nitrosurea or mitomycin-C) or who are within 5 half-lives of their last dose chemotherapy dose prior to starting study drug or who have not recovered from side effects of such therapy.
- •Patients who have received Gleevec® = 1 week or who have not recovered from side effects of such therapy.
- •Patients who have received immunotherapy =1 week prior to starting study drug or who have not recovered from side effects of such therapy
- •Patients who have received any investigational drug = 4 weeks or investigational cytotoxic agent within 1 week (or who are within 5 half-lives of a previous investigational cytotoxic agent) prior to starting study drug or who have not recovered from side effects of such therapy
- •Patients who have received wide field radiotherapy = 4 weeks or limited field radiation for palliation < 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy
- •Patients who have undergone major surgery = 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy
- •Patients who are pregnant or breast feeding, or adults of reproductive potential not employing an effective method of birth control. (Women of childbearing potential must h
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