EUCTR2004-001483-51-FI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 - NA
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
- •Patients with a cytopathologically confirmed diagnosis of Ph+ ALL who are either relapsed after or refractory to standard therapy, or patients with CML in BC, or CML patients in CP or AP 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.
- •Phase II- CML
- •1. Imatinib resistant or intolerant Ph+ CML in blast crisis defined as at least 30% blasts in peripheral blood or bone marrow or extramedullary disease other than liver or spleen
- •2. Imatinib resistant or intolerant Ph+ CML patients in accelerated phase defined as never in blast crisis before starting treatment, with one or more of the following criteria present within 4 weeks prior to beginning treatment:
- •=15% but <30% blasts in blood or bone marrow
- •=30% blasts plus promyelocytes in peripheral blood or bone marrow (providing that <30% blasts present in bone marrow)
- •peripheral basophils =20%
- •thrombocytopenia <100 X 109 /L unrelated to therapy
- •3. Imatinib resistant or intolerant Ph+ CML in chronic phase defined as never in blast crisis or accelerated phase before starting treatment and the presence of the following criteria:
- •< 15% blasts in peripheral blood and bone marrow
- •< 30% blasts plus promyelocytes in peripheral blood and bone marrow
- •< 20% basophils in the peripheral blood
- •= 100 x 109 /L (= 100,000 /mm3) platelets
- •No evidence of extramedullary leukemic involvement, with the exception of liver or spleen
- •Phase II: Relapsed or refractory Ph+ ALL
- •Patients with Ph+ ALL who have minimal residual disease (MRD) are eligible only if there is indication of evolving relapse defined as a = 2 log increase of Bcr-Abl transcript level (as reported by local laboratories), as compared to the minimum level achieved with prior therapy in peripheral blood
- •Patients with Ph+ALL whose disease exhibits features of biphenotypic acute leukemia are eligible
- •Phase II: Hypereosinophilic syndrome/chronic eosinophilic leukemia
- •eosinophilia greater than 1500/mm3 for at least 6 months
- •exclusion of other causes of eosinophilia including clonal or abnormal T-cell populations, exclusion of reactive eosinophilia, and malignancies or T-cell disorders associated with eosinophilia
- •signs and symptoms of organ involvement
- •Phase II: Systemic mastocytosis who have a clinical indication for treatment and meet at least one major and one minor or three minor criteria (
- •Major criterion: Multifocal dense infiltrates of mast cells (>15 mast cells in aggregates) in bone marrow biopsies and/or in sections of other extracutaneous organ(s).
- •Minor Criteria: see protocol section 3.3.2.1.2
- •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.
- •Patients who are currently receiving treatment with any of the medications listed in Post-text supplement 4 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 have the potential to prolong the QT interval.
- •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 have a negative serum pregnancy test within
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