NCT00447005已完成1 期
A Phase 1 Study Of AG-013736 (Axitinib) In Japanese Patients With Advanced Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
To evaluate the clinically recommended dose of AG-013736 (Axitinib) in Japanese patients by reviewing the safety of AG-013736 (Axitinib) following single and multiple dosing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients histologically or cytologically diagnosed with advanced malignant solid tumors
- •Patients for whom standard therapies have not been effective, or for whom there are no suitable therapies
排除标准
- •Central lung lesions involving major blood vessels
- •Patients who have been treated with bevacizumab or other VEGFR inhibitor(s)
研究组 & 干预措施
Open
Experimental
干预措施: Axitinib (AG-013736) (Drug)
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: Up to 795 days of treatment plus 28-days follow-up
Number of participants with any adverse events, adverse events graded as Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE) Grade 3 or higher, serious adverse events, and adverse events resulted in discontinuation.
次要结局
- Maximum Observed Plasma Concentration (Cmax): Single Dose(Single dose: predose, 0.5, 1, 2, 4, 6, 8, 12, 24, and 32 hours postdose)
- Time to Reach Maximum Observed Plasma Concentration (Tmax): Single Dose(Single dose: predose, 0.5, 1, 2, 4, 6, 8, 12, 24, and 32 hours postdose)
- Area Under The Plasma Concentration-Time Curve From Time Zero to Time Infinity (AUCinf): Single Dose(Single dose: predose, 0.5, 1, 2, 4, 6, 8, 12, 24, and 32 hours postdose)
- Terminal Phase Plasma Half-Life (t1/2): Single Dose(Single dose: predose, 0.5, 1, 2, 4, 6, 8, 12, 24, and 32 hours postdose)
- Maximum Observed Plasma Concentration (Cmax): Multiple Dose(Multiple dose Cycle 1 Day 1 and 15: predose, 0.5, 1, 2, 4, 8 and 12 hours postdose)
- Time to Reach Maximum Observed Plasma Concentration (Tmax): Multiple Dose(Multiple dose Cycle 1 Day 1 and 15: predose, 0.5, 1, 2, 4, 8 and 12 hours postdose)
- Area Under The Plasma Concentration-Time Curve Over Dosing Interval Tau (AUCtau): Multiple Dose(Multiple dose Cycle 1 Day 1 and 15: predose, 0.5, 1, 2, 4, 8 and 12 hours postdose)
- Accumulation Ratio for Cmax (Rac Cmax) and Accumulation Ratio for AUCtau (Rac AUCtau): Multiple Dose(Multiple dose Cycle 1 Day 1 and 15: predose, 0.5, 1, 2, 4, 8 and 12 hours postdose)
- Percent Change From Baseline in Soluble Vascular Endothelial Growth Factor Receptor 2 and 3 (s-VEGFR2 and s-VEGFR3), Vascular Endothelial Growth Factor (VEGF), Soluble Stem Cell Factor Receptor (s-KIT)(Prior to the initial dose (baseline), Day 1 of Cycle 2 and at the discontinuation)
- The Numbers of Participants With Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progression of Disease (PD) According to the Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0)(Up to 795 days)
研究者
研究点 (1)
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