ACTRN12610000093088已完成2 期
B2P2M2: Phase II, single arm trial to evaluate the response rate of BNC105P as 2nd line chemotherapy for advanced malignant pleural mesothelioma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Confirmed diagnosis of malignant pleural mesothelioma.
- •2. Progression after first line chemotherapy with pemetrexed and a platinum (cisplatin and/or carboplatin).
- •3. Evidence of measurable disease as per RECIST modified for mesothelioma.
- •4. Performance status of ECOG 0-1.
- •5. Adequate hepatic, renal and haematological function.
- •6. Adequate cardiac function as assessed by Left ventricular ejection fraction (LVEF) and corrected QT interval (QTc).
- •7. Patient is able and willing to complete the Quality of Life (QOL) questionnaires, or unable due to illiteracy or visual impairment. Inability to complete the questionnaires will not exclude the patient from the study.
- •8. Patient is willing and able to comply with treatment and follow up.
- •9. Written informed consent.
排除标准
- •1. Any prior chemotherapy other than pemetrexed and a platinum compound.
- •2. Chemotherapy within 20 days, radiotherapy within 14 days, major surgery within 28 days
- •3. Known brain or leptomeningeal disease
- •4. History of another malignancy within 5 years prior to registration
- •5. Untreated and/or uncontrolled cardiovascular conditions
- •6. Stroke, venous or arterial blood clots within 12 months prior to registration.
- •7. Poorly controlled hypertension
研究者
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