Phase I Clinical Trial of Combined Fostamatinib and Paclitaxel in Ovarian Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 3
- 主要终点
- Safety and Tolerability of Fostamatinib
研究概览
简要总结
This research is being done to test the safety of the combination of the study drugs fostamatinib and paclitaxel. This study tests different doses of the drugs to see which doses are safest in people with ovaria cancer when given together.
详细描述
This is a phase I, open-label, non-randomized multicenter dose-escalation study with the primary objective to determine the maximally tolerated dose (MTD) of fostamatinib when administered with weekly paclitaxel in women with recurrent platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer.
Between 8 and 18 adult female subjects will be enrolled and receive weekly paclitaxel in combination with increasing doses of fostamatinib. There will be three dosing intervals of fostamatinib (100 mg bid, 150 mg bid, and 200mg bid) selected based on prior phase I studies of single agent fostamatinib. Dose-escalation will follow a modified toxicity probability interval (mTPI) design. In this study, up to 18 adult female subjects will be enrolled and receive weekly paclitaxel in combination with fostamatinib at the MTD of the combination; at least 6 patients with receive fostamatinib plus paclitaxel at the MTD.
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 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Fostamatinib 100 mg bid and Paclitaxel
Participants will receive paclitaxel on Days 1, 8 and 15 of each cycle and fostamatinib at a fixed oral dose of 100mg twice daily throughout each 28-day cycle.
干预措施: Fostamatinib 100 mg bid and Paclitaxel (Drug)
Fostamatinib 150 mg bid and Paclitaxel
Participants will receive paclitaxel on Days 1, 8 and 15 of each cycle and fostamatinib at a fixed oral dose of 150mg twice daily throughout each 28-day cycle.
干预措施: Fostamatinib 150 mg bid and Paclitaxel (Drug)
Fostamatinib 200 mg bid and Paclitaxel
Participants will receive paclitaxel on Days 1, 8 and 15 of each cycle and fostamatinib at a fixed oral dose of 150mg twice daily throughout each 28-day cycle.
干预措施: Fostamatinib 200 mg bid and Paclitaxel (Drug)
结局指标
主要结局
Safety and Tolerability of Fostamatinib
时间窗: First cycle (28 days) of treatment
The number of dose limiting toxicities (DLTs) at each dose level will be reported. All toxicities will be reported by type and grade using NCI CTCAE version 4.03.
Maximum Tolerated Dose (MTD) of Fostamatinib
时间窗: 28 days
The MTD will be determined as the dose level with the highest probability of having a risk of DLT in the acceptable region based on the mTPI dose-escalation design. Measured at 28 days (DLT period).
次要结局
- Objective Response Rate in the Study Population Treated With the Combination of Fostamatinib and Paclitaxel(5 years)
- Progression-free Survival in the Study Population Treated With the Combination of Fostamatinib and Paclitaxel(5 years)
- Pharmacokinetic (PK) Profile of Fostamatinib When Combined With Weekly Paclitaxel - Tmax(First cycle (28 days) of treatment)
- Pharmacokinetic (PK) Profile of Fostamatinib When Combined With Weekly Paclitaxel - Cmax(First cycle (28 days) of treatment)
- Pharmacokinetic (PK) Profile of Fostamatinib When Combined With Weekly Paclitaxel - Area Under the Curve (AUC) 0-6hours(First cycle (28 days) of treatment)