A Phase 1 Study In Patients With Advanced Solid Tumor To Evaluate The Pharmacokinetics And Safety Of AG-013736 At Single Doses Of 5 mg, 7 mg And 10 mg, And At Multiple Doses
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Single Dose: Maximum Observed Plasma Concentration (Cmax)
研究概览
简要总结
This study designed to evaluate the pharmacokinetics and safety of AG-013736 at single doses and multiple doses
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 —（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 solid tumors
- •Patients for whom standard therapies have not been effective, or for whom there are no suitable therapies
- •Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1 or 2
- •Patients with no uncontrolled hypertension
排除标准
- •Patients who have central lung lesions involving major blood vessels
- •Patients who require anticoagulant therapy.
- •Patients with active epilepsy seizure or symptoms, with brain metastases requiring treatment, with spinal cord compression and with carcinomatous meningitis.
研究组 & 干预措施
Axitinib
干预措施: Axitinib (AG-013736) (Drug)
结局指标
主要结局
Single Dose: Maximum Observed Plasma Concentration (Cmax)
时间窗: Predose, 0.5, 1, 2, 4, 6, 8, 10, 24, and 32-hour postdose
Area Under the Plasma Concentration-Time Curve From Time Zero to Time Infinity (AUCinf)
时间窗: Predose, 0.5, 1, 2, 4, 6, 8, 10, 24, and 32-hour postdose
AUCinf is obtained from AUC (0 - t) plus AUC (t - infinity).
Single Dose: Time to Reach Maximum Observed Plasma Concentration (Tmax)
时间窗: Predose, 0.5, 1, 2, 4, 6, 8, 10, 24, and 32-hour postdose
Single Dose: Plasma Decay Half-Life (t1/2)
时间窗: Predose, 0.5, 1, 2, 4, 6, 8, 10, 24, and 32-hour postdose
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
次要结局
- Multiple Dose: Maximum Observed Plasma Concentration (Cmax)(Cycle 1 Day 15 predose in the morning, and 0.5, 1, 2, 4, 8 and 12 hour postdose)
- Multiple Dose: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)(Cycle 1 Day 15 predose in the morning, and 0.5, 1, 2, 4, 8 and 12 hour postdose)
- Multiple Dose: Time to Reach Maximum Observed Plasma Concentration (Tmax)(Cycle 1 Day 15 predose in the morning, and 0.5, 1, 2, 4, 8 and 12 hour postdose)
- Multiple Dose: Accumulation Ratio for Cmax (Rac Cmax) and Accumulation Ratio for AUCtau (Rac AUCtau)(Cycle 1 Day 15 predose in the morning, and 0.5, 1, 2, 4, 8 and 12 hour postdose)
- Percent Change From Baseline in Soluble Vascular Endothelial Growth Factor Receptor 1, 2, and 3 (s-VEGFR1, s-VEGFR2 and s-VEGFR3), Vascular Endothelial Growth Factor (VEGF), Soluble Stem Cell Factor Receptor (s-KIT )(Prior to the initial dose (baseline) and Day 1 of Cycle 2)
- Number 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 470 days)
- Number of Participants With Adverse Events(Up to 470 days of treatment plus 28-days follow-up)