Phase I Study of the Non-receptor Kinase Inhibitor Bosutinib in Combination With Pemetrexed in Patients With Selected Metastatic Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Dose-limiting toxicity of the combination of bosutinib and pemetrexed
研究概览
简要总结
This study will determine the maximum-tolerated dose (MTD) for oral bosutinib when used in combination with pemetrexed. The MTD is the highest dose of bosutinib with pemetrexed that can be given without causing severe side effects. This study will also test the safety of this combination and see what effects (good or bad) it has on participants and their cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically or cytologically proven advanced, metastatic non-squamous non-small cell lung cancer, pleural malignant mesothelioma, bladder or urethral cancer, ovarian cancer, primary peritoneal cancer, thymoma and thymic cancer and uterine cervical cancer.
- •Measurable disease
- •Life expectancy of greater than 3 months.
- •Ability to take folic acid, vitamin B12, and dexamethasone according to protocol.
排除标准
- •Untreated or symptomatic brain metastases.
研究组 & 干预措施
Bosutinib and Pemetrexed
Bosutinib and pemetrexed
干预措施: Bosutinib (Drug)
Bosutinib and Pemetrexed
Bosutinib and pemetrexed
干预措施: Pemetrexed (Drug)
结局指标
主要结局
Dose-limiting toxicity of the combination of bosutinib and pemetrexed
时间窗: 21 days
CTCAE Grade 3 or 4 non-hematologic toxicities other than alopecia, nausea and vomiting.
Maximum tolerated dose of the combination of bosutinib and pemetrexed
时间窗: completion of dose escalation
次要结局
- Adverse events of the combination of bosutinib and pemetrexed(16 weeks)
- Anti-tumor response rate(6 and 12 weeks)
- Progression-free survival(6 and 12 weeks)
研究者
Nagla Abdel Karim
Associate Professor of Medicine
Augusta University