EUCTR2007-000241-35-GB进行中（未招募）1 期
A Phase I/II Clinical Trial of PXD101 in Combination with Idarubicin in Patients with AML Not Suitable for Standard Intensive Therapy
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 70
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
入选标准
- •Inclusion criteria
- •1.Signed consent of an IEC-approved informed consent form.
- •2.AML patients evaluable for efficacy:
- •a. patients above 60 years in first relapse or refractory.
- •b. patients 18-60 years 2nd relapse or refractory to at least two intensive chemotherapy cycles.
- •c. patients above 60 years with high risk features (cytogenetics, secondary or treatment related AML).
- •d) patients above 60 years with myelodysplastic syndrome with > 10% blasts in bone marrow (WHO RAEB-2). For patients below 60 years potential curative treatments should have been exhausted.
- •3.Performance status (ECOG) = 2.
- •4.Age ³ 18 years.
- •5.Acceptable liver, renal and bone marrow function including the following:
- •a.Bilirubin < 1.5 times upper limit of normal (ULN)
- •b.AST (SGOT) or ALT (SGPT) and Alkaline Phosphatase < 3 times upper limit of normal.
- •c.Serum creatinine < 1.5 times upper limit of normal (ULN).
- •6.Serum potassium within normal range.
- •7.Acceptable coagulation status: APTT and PT or INR within < 1.5 times upper limit of normal or in the therapeutic range if on anticoagulation.
- •8.Female patients with reproductive potential with a negative pregnancy test within the last 7 days before trial enrollment and must use a safe contraceptive during and for a period of 60 days after the trial. Fertile female partners to male participants must likewise use contraceptive for the same period.
- •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
- •Exclusion Criteria
- •1.Treatment with investigational agents within the last 4 weeks.
- •2.Prior treatment with HDAC inhibitors including valproic acid.
- •3.Prior antileukemic therapy, within the last 3 weeks before trial dosing including chemotherapy, radiotherapy, endocrine therapy or immunotherapy. Cytoreduction with hydroxyurea for high blood counts is allowed during the pre-trial investigation phase but the treatment should be discontinued at least 3 days before the PXD101 treatment.
- •4.Co-existing active infection (including HIV) or any co-existing medical condition likely to interfere with trial procedures, including significant cardiovascular disease (New York Heart Association Class III or IV) cardiac disease, myocardial infarction within the past 6 months, unstable angina, congestive heart failure requiring therapy, unstable arrhythmia or a need for anti-arrhythmic therapy, uncontrolled hypertension, bradycardia with heart rate <50/min or evidence of ischemia on ECG, marked baseline prolongation of QT/QTcF interval, e.g., repeated demonstration of a QTcF interval > 450 msec; Long QT Syndrome; the required use of concomitant medication on PXD101 infusion days that may cause Torsade de Pointes. (See Appendix B).
- •5.Altered mental status precluding understanding of the informed consent process and/or completion of the necessary study procedures.
- •6.Concurrent second malignancy
- •7.History of hypersensitivity to idarubicin..
- •8.Cumulative idarubicin dose above 100 mg/m2 (or with respect to cardiotoxicity) corresponding doses of other anthracyclines.
- •9.LVEF below normal range (< 45% )
- •10.Known CNS leukaemia.
研究者
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