A Phase 1, Open-Label, Dose Escalation Study To Evaluate Safety, Pharmacokinetics And Pharmacodynamics Of PF-04554878 In Patients With Advanced Non-Hematologic Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Recommended Phase 2 Dose
研究概览
简要总结
Phase 1 safety, pharmacokinetics, and pharmacodynamics trial of the focal adhesion kinase (FAK) inhibitor PF-04554878 in patients with advanced non-hematologic malignancies, including patients with malignancies appropriate for serial biopsy. Screening consists of medical history, physical examination ECOG performance status, blood draws, a pregnancy test for female patients of childbearing potential, a FDG-PET and tumor imaging. Treatment consists of PF-04554878 pills continued until progression of disease, unacceptable toxicity, or patient request. Evaluations for bioactivity are measured by serial FDG-PET and blood tests for biomarkers related to FAK and Pyk2 activities.
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
- •Patients with advanced non-hematologic malignancies.
- •Adequate organ function, including bilirubin less than 1.5 x ULN, and ECOG (Eastern Cooperative Oncology Group) performance status of 0-2.
排除标准
- •Clinically significant gastrointestinal abnormalities, requirement for systemic anticoagulants or potent CYP 2C8 inhibitors, and history of clinically significant cardiac or pulmonary disorders
研究组 & 干预措施
1
Dose escalation study with Expansion Cohorts at RP2D and Schedule
干预措施: PF-04554878 (Drug)
结局指标
主要结局
Recommended Phase 2 Dose
时间窗: 18 months
Overall safety profile of PF-04554878, including Dose-Limiting Toxicity (DLT)
时间窗: 18 months
次要结局
- Tumor metabolic response(18 months)
- FAK-related biomarkers in tumor biopsies and blood(18 months)
- Molecular profiling (genomics data) based on the optional studies with whole blood and/or tumor samples(18 months)
- PF-04554878 pharmacokinetic (PK) parameters and Midazolam PK parameters(18 months)