NCT02462707撤回1 期
Phase 1 Study Of Pf-03084014 To Evaluate Safety And Pharmacokinetics 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
- 撤回
- 发起方
- Pfizer
- 主要终点
- First-cycle Dose Limiting Toxicities
研究概览
简要总结
The purpose of this study is to determine the recommended Phase 2 dose for PF-03084014 single-agent administration in Japanese patients with advanced solid tumors. Pharmacokinetics and the overall safety profile of PF-03084014 will also be evaluated.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 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
- •Histological or cytological diagnosis of advanced solid tumors that is resistant to standard therapy or for which no standard therapy is available.
- •Age ≥18 years.
- •ECOG Performance Status (PS) must be 0 or
- •Adequate Bone Marrow Function
- •Adequate Renal Function
- •Adequate Liver Function
- •Resolved acute effects of any prior therapy to baseline severity or Grade ≤1
排除标准
- •Patients with known brain metastases
- •Major surgery within 4 weeks of starting study treatment
- •Radiation therapy within 2 weeks of starting study treatment
- •Systemic anti cancer therapy within 2 weeks (4 weeks for antibody) of starting study treatment
- •Previous high dose chemotherapy requiring stem cell rescue
- •Prior irradiation to >25% of the bone marrow
- •Prior treatment with a Notch signal inhibitor
- •Known malabsorption syndrome or other condition that may impair absorption of study medication
- •Any of the following in the previous 6 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism
- •Current use or anticipated need for known strong and/or moderate CYP3A4 inhibitors
- •Current use or anticipated need for known strong CYP3A4 inducers
研究组 & 干预措施
PF-03084014
Experimental
干预措施: PF-03084014 (Drug)
结局指标
主要结局
First-cycle Dose Limiting Toxicities
时间窗: during the first 28 days from the first dose
次要结局
- Maximum Observed Plasma Concentration (Cmax)(0, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose)
- Apparent Oral Clearance (CL/F)(0, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose)
- Apparent Volume of Distribution at steady state (Vss/F)(0, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose)
- Minimum Observed Plasma Trough Concentration (Cmin)(0, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose)
- Average Serum Concentration at steady state (Cav)(0, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose)
- QTc interval(from the first dose to the last dose)
- Time to Reach Maximum Observed Plasma Concentration (Tmax)(0, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose)
- Area Under the Curve from Time Zero to end of dosing interval (AUCtau)(0, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose)
- Plasma Decay Half-Life (t1/2)(0, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose)
- Accumulation Ratio (Rac)(0, 0.5, 1, 2, 4, 8 hours post-dose on Day 1 and Day 21)
研究者
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