A Phase 1 Pharmacokinetic And Pharmacodynamic Study Of Pf-03446962 In Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 70
- 试验地点
- 10
- 主要终点
- Recommended Phase 2 Dose (RP2D): Part 1
研究概览
简要总结
The purpose of this study is to test the safety and effectiveness of PF-03446962 when given as a single agent. Tumors require new blood vessels to support their ability to grow and to spread (metastasize). New treatments aimed at preventing these blood vessels have the ability to improve the clinical management of 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
- •Advanced measurable or non-measurable solid tumors
- •Adequate bone marrow function
- •Adequate liver function
- •Adequate renal function
- •Be able and willing to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures
排除标准
- •Chemotherapy, radiotherapy, or any investigational cancer therapy within 4 weeks of first dose of study medication
- •Active bleeding disorder, including gastrointestinal bleeding, as evidenced by hematemesis, hemoptysis or melena in the past 6 months
- •Any of the following within the 12 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident including transient ischemic attack, or pulmonary embolus; or any other active thromboembolic event
- •QTc prolongation defined as QTc >450 msec
- •Patients with known brain metastasis
- •Patients with peritoneal carcinosis at risk of bleeding
- •Major surgical procedure within 4 weeks of treatment
- •Pregnancy or breastfeeding
研究组 & 干预措施
1
干预措施: PF-03446962 (Drug)
结局指标
主要结局
Recommended Phase 2 Dose (RP2D): Part 1
时间窗: Baseline up to 42 days after the start of each increased treatment dose
RP2D was defined as the lower dose level to MTD based on the safety profile.
Maximum Tolerated Dose (MTD): Part 1
时间窗: Baseline up to 42 days after the start of each increased treatment dose
MTD was defined as highest dose level for which no more than 1 participant in a dose cohort experienced DLT and at least 2 out of 3/6 participants in the next higher dose. DLT was defined as any of the following events occurring during the first 42 days of study drug: any grade greater than or equal to 3 hematologic and non-hematologic toxicity, all non-disease-related adverse events (AEs).
次要结局
- Time to Treatment-Emergent Adverse Events (AEs): Part 1 and Part 2(Cycle 1 of Day 1 up to 28 days after the last dose of treatment)
- Percentage of Participants With Objective Response: Part 1 and Part 2(Baseline then 6 weeks after Cycle 1 of Day1 thereafter every 6 weeks up to Day 490)
- Number of Participants With Treatment Emergent Adverse Events (AEs) Based on Severity: Part 1 and Part 2(Cycle 1 of Day 1 up to 28 days after the last dose of treatment)
- Number of Participants With Treatment-Emergent Adverse Events (AEs): Part 1 and Part 2(Cycle 1 of Day 1 up to 28 days after the last dose of treatment)
- Number of Participants With Treatment Emergent Adverse Events (AEs) Based on Seriousness: Part 1 and Part 2(Cycle 1 of Day 1 up to 28 days after the last dose of treatment)
- Number of Participants With Laboratory Abnormalities: Part 1 and Part 2(Cycle 1 of Day 1 up to 28 days after the last dose of treatment)
- Percentage of Participants With Disease Control: Part 2(Baseline then 6 weeks after Cycle 1 of Day1 thereafter every 6 weeks up to Day 490)
- Time To Progression (TTP): Part 2(Baseline then 6 weeks after Cycle 1 of Day1 thereafter every 6 weeks up to Day 490)
- Volume of Distribution: Part 1 and Part 2(0 hr (pre-dose),0.5,1,1.5,2,5,10,24 hr post-dose on Day (D) 1,3,5,8,11,15,22 of Cycle (C) 1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to cycle 12, 28 days after last dose for dose (up to 3 months after last dose for >=2 mg/kg arms))