EUCTR2006-004345-42-DK进行中（未招募）不适用
A Phase I/II Clinical Trial of PXD101 in Combination with Doxorubicin in Patients with Soft Tissue Sarcomas
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
- 55
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
- •Inclusion Criteria
- •1.Signed consent of an IEC-approved Information consent form
- •2.A. For the dose escalation phase: Patients with histological or cytological confirmed solid tumours (including sarcomas), for which there is no known curative therapy
- •B. For the MTD expansion phase: Patients with an established diagnosis of soft tissue sarcoma in need of first line chemotherapy and with measurable disease
- •3.Performance status (ECOG) = 2
- •4.Life expectancy of at least 3 months
- •5.Age ³ 18 years
- •6.Acceptable liver, renal and bone marrow function including the following:
- •a.Bilirubin = 1.5 times upper limit of normal (ULN)
- •b.AST (SGOT), ALT (SGPT) and Alkaline Phosphatase = 3 times upper limit of normal (if liver metastases are present, then = 5 x ULN is allowed)
- •c.Serum creatinine = 1.5 times upper limit of normal (ULN)
- •d.Leucocytes > 2.5 x 109/L, neutrophils > 1.0 x 109/L, platelets > 100 x 109/L
- •e.Haemoglobin > 9.0 g/dL or > 5.6 mmol/l
- •7.Acceptable coagulation status: PT and APTT within = 1.5 times upper limit of normal or in the therapeutic range if on anticoagulation.
- •8.A negative pregnancy test for women of childbearing potential. For men and women of child-producing potential, the use of effective contraceptive methods during the study is required
- •9.Serum potassium within normal range
- •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 27
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 28
排除标准
- •Exclusion Criteria
- •1.Treatment with investigational agents within the last 4 weeks
- •2.Prior anticancer therapy, within the last 3 weeks of trial dosing including chemotherapy, radiotherapy, endocrine therapy or immunotherapy
- •3.Co-existing active infection 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, or evidence of ischemia on ECG, marked baseline prolongation of QT/QTc interval, e.g., repeated demonstration of a QTc interval > 500 msec; Long QT Syndrome; the required use of concomitant medication on PXD101 infusion days that may cause Torsade de Pointes. (See Appendix A).
- •4.Altered mental status precluding understanding of the informed consent process and/or completion of the necessary studies
- •5.Concurrent second malignancy
- •6.History of hypersensitivity to doxorubicin
- •7.A. For dose escalation phase: More than two prior doses of anthracycline, more than three prior lines of chemotherapy given for metastatic disease
- •B. For MTD expansion phase: Prior chemotherapy
- •8.Bowel obstruction or impending bowel obstruction
- •9.Known HIV positivity
- •10.LVEF below normal range ( 45% by MUGA)
- •11.Presence of metastatic disease that, in the opinion of the investigator, would require palliative treatment within 4 weeks of enrolment
研究者
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