Phase I Study of Cabozantinib in Combination With Pemetrexed in Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC), Urothelial Cancer and Advanced Malignant Mesothelioma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Assess the maximum tolerated dose (MTD) of cabozantinib in combination with pemetrexed
研究概览
简要总结
This study will combine cabozantinib with pemetrexed to treat patients with non-small cell lung cancer, urothelial cancer and advanced malignant mesothelioma. This study will test the safety of both drugs used together and see what effect (good or bad) it has no 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
- •Locally advanced NSCLC, urothelial cancer or malignant mesothelioma.
- •18 years or older.
- •At least one prior chemotherapy before entering in this trial.
- •Not pregnant or breastfeeding.
排除标准
- •Prior treatment with cabozantinib.
- •Currently receiving cancer treatment (last dose 2 weeks prior to enrollment in study).
- •History of bleeding disorder/bleeding history within 12 weeks before first study treatment dose.
研究组 & 干预措施
Cabozantinib + Pemetrexed
Pemetrexed 500mg/m2 IV day 1 of each 21 day cycle + Cabozantinib 20-60mg by mouth once a day.
干预措施: Cabozantinib (Drug)
Cabozantinib + Pemetrexed
Pemetrexed 500mg/m2 IV day 1 of each 21 day cycle + Cabozantinib 20-60mg by mouth once a day.
干预措施: Pemetrexed (Drug)
结局指标
主要结局
Assess the maximum tolerated dose (MTD) of cabozantinib in combination with pemetrexed
时间窗: 4 weeks or 28 days assessment.
Dose-limiting toxicity of grade 3 or higher using CTCAE 5
次要结局
- Assess objective response rate (RR)(To be measured through study completion; an average of 1 year.)
- Progression-free survival (PFS)(To be measured through study completion; an average of 1 year.)
- Overall survival (OS).(OS measured through study completion, and an average of 1 year)
研究者
Nagla Abdel Karim
Professor, Hematology/Oncology, Director of Thoracic Oncology and Phase I Program
Augusta University