NCT00783328已完成1 期
A Clinical Phase 1 Safety And Pharmacokinetic/Pharmacodynamic Study Of PF-00299804 In Patients In Japan With Advanced Malignant 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
- 13
- 试验地点
- 1
- 主要终点
- Overall safety: type, grade and frequency of all adverse events and laboratory abnormalities
研究概览
简要总结
To evaluate safety and tolerability of PF-00299804 in Japanese patients with advanced malignant solid tumors at doses up to the clinically recommended phase 2 dose in non-Japanese studies.
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
- •Malignant solid tumor with no currently approved treatment
- •Adequate functions Bone Marrow, Renal, Liver and Cardiac
排除标准
- •Any surgery, radiotherapy within 4 weeks of baseline disease assessments
- •Clinically significant abnormalities of the cornea
- •Patients with symptomatic brain/central nerve system metastases
- •Any clinically significant gastrointestinal abnormalities
- •Uncontrolled or significant cardiovascular disease
- •Patients with significant interstitial pneumonia or pulmonary fibrosis
研究组 & 干预措施
1
Experimental
Open label single arm trial
干预措施: PF-00299804 (Drug)
结局指标
主要结局
Overall safety: type, grade and frequency of all adverse events and laboratory abnormalities
时间窗: End of study
次要结局
- To explore PD markers(End of study)
- To evaluate the plasma pharmacokinetics of PF-00299804 in Japanese patients following single and multiple dosing(End of study)
- To assess any clinical evidence of anti-tumor activity of PF-00299804 per RECIST(End of study)
研究者
研究点 (1)
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