NCT01286467已完成1 期
A PHASE 1 STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF PF 04449913, AN ORAL HEDGEHOG INHIBITOR, ADMINISTERED AS SINGLE AGENT IN SELECT 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
- 23
- 试验地点
- 9
- 主要终点
- Number of Participants With First Cycle Dose Limiting Toxicities (DLTs)
研究概览
简要总结
This study examines the effect of a small molecule inhibitor to the Sonic Hedgehog pathway on select solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological or cytological diagnosis of advanced/metastatic solid tumor
- •Adequate Bone Marrow Function
- •Adequate Renal Function
- •Adequate Liver Function
排除标准
- •Patients with known symptomatic brain metastases requiring steroids
- •Current active treatment on another clinical trial
- •Major surgery or radiation therapy within 4-weeks of starting study treatment
研究组 & 干预措施
1
Experimental
干预措施: PF-04449913 (Drug)
结局指标
主要结局
Number of Participants With First Cycle Dose Limiting Toxicities (DLTs)
时间窗: Baseline up to end of Cycle 1 (Study Day 28)
Any DLT event in Cycle 1: (1) Grade 4 neutropenia lasting more than 7 days; (2) Febrile neutropenia; (3) Grade \>=3 neutropenic infection; (4) Grade \>=3 thrombocytopenia with bleeding; (5) Grade 4 thrombocytopenia lasting more than 7 days; (6) Grade \>=3 non-hematologic toxicity; (7) Failure to deliver at least 80% of the planned doses due to toxicities attributable to PF-04449913
次要结局
- Percentage of Participants With Treatment-emergent Adverse Events (AEs), by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (Version 4.0) Grade(Baseline up to 28 days post last dose of study medication (maximum duration: 14 cycles [each cycle of 28 days]))
- Percentage of Participants With Treatment-related AEs, by NCI CTCAE (Version 4.0) Grade(Baseline up to 28 days post last dose of study medication (maximum duration: 14 cycles [each cycle of 28 days]))
- Hedgehog Biomarker Modulation: Relative GLI1 Gene Expression (Ratio) to Baseline for Normal Skin on Cycle 1/Day 15(Baseline and Cycle 1/Day 15)
- Maximum Observed Plasma Concentration (Cmax) on Cycle 1/Day 1(Pre dose, 1, 2, 4, 6, 10 and 24 hours post dose on Cycle 1/Day 1)
- Maximum Observed Plasma Concentration (Cmax) on Cycle 1/Day 25(Pre dose, 1, 2, 4, 10, 24, 48, 72 and 96 hours post dose on Cycle 1/Day 25)
- Time to Reach Maximum Observed Plasma Concentration (Tmax) on Cycle 1/Day 1(Pre dose, 1, 2, 4, 6, 10 and 24 hours post dose on Cycle 1/Day 1)
- Time to Reach Maximum Observed Plasma Concentration (Tmax) on Cycle 1/Day 25(Pre dose, 1, 2, 4, 10, 24, 48, 72 and 96 hours post dose on Cycle 1/Day 25)
- Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) on Cycle 1/Day 1(Pre dose, 1, 2, 4, 6, 10 and 24 hours post dose on Cycle 1/Day 1)
- Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) on Cycle 1/Day 25(Pre dose, 1, 2, 4, 10, 24, 48, 72 and 96 hours post dose on Cycle 1/Day 25)
- Plasma Decay Half-life (t1/2) on Cycle 1/Day 25(Pre dose, 1, 2, 4, 10, 24, 48, 72 and 96 hours post dose on Cycle 1/Day 25)
- Apparent Oral Clearance (CL/F) on Cycle 1/Day 25(Pre dose, 1, 2, 4, 10, 24, 48, 72 and 96 hours post dose on Cycle 1/Day 25)
- Apparent Volume of Distribution (Vz/F) on Cycle 1/Day 25(Pre dose, 1, 2, 4, 10, 24, 48, 72 and 96 hours post dose on Cycle 1/Day 25)
- Accumulation Ratio (Rac) on Cycle 1/Day 25(Pre dose, 1, 2, 4, 6, 10 and 24 hours post dose on Cycle 1/Day 1, and pre dose, 1, 2, 4, 10, 24, 48, 72 and 96 hours post dose on Cycle 1/Day 25)
- Average Concentration at Steady State (Cavg) on Cycle 1/Day 25(Pre dose, 1, 2, 4, 10, 24, 48, 72 and 96 hours post dose on Cycle 1/Day 25)
- Number of Participants With Increase From Baseline in Corrected QT Using Fridericia's Formula (QTcF) Interval(Baseline up to Cycle 14 (each cycle 28 days))
- Duration of Response (DR)(Baseline up to Cycle 14 (each cycle 28 days))
- Number of Participants With Decrease From Baseline in QTcF Interval(Baseline up to Cycle 14 (each cycle 28 days))
- Percentage of Participants With Objective Response(Baseline up to Cycle 14 (each cycle 28 days))
- Progression-Free Survival (PFS)(Baseline up to Cycle 14 (each cycle 28 days))
- Number of Participants With Post-baseline QTcF Interval Greater Than or Equal to 500 Msec(Baseline up to Cycle 14 (each cycle 28 days))
- Time to Progression (TTP)(Baseline up to Cycle 14 (each cycle 28 days))
研究者
研究点 (9)
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