A Phase 1-2 Study of the VEGF Receptor Tyrosine Kinase Inhibitor PTK787/ZK 222584 <Vatalanib> and Gemcitabine in Patients With Advanced Pancreatic Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Time-to-Treatment Failure (Intent-To-Treat Analysis)
研究概览
简要总结
The purpose of the study is to determine the optimal safe and tolerable dose of gemcitabine in combination with once daily or twice daily dose of PTK/ZK in patients with unresectable pancreatic cancer. The Phase II part of this study planned to determine the antitumor activity of this regimen and its effectiveness of preventing tumor growth and spread.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Stage 1 Dose Exploration 0 - Gemcitabine 700 + vatalanib 1250
Gemcitabine 700 mg/m2 + vatalanib 1250 mg daily
干预措施: Vatalanib (Drug)
Stage 1 Dose Exploration 0 - Gemcitabine 700 + vatalanib 1250
Gemcitabine 700 mg/m2 + vatalanib 1250 mg daily
干预措施: Gemcitabine (Drug)
Stage 1 Dose Exploration 1 - Gemcitabine 850 + vatalanib 1250
Gemcitabine 850 mg/m2 + vatalanib 1250 mg
干预措施: Vatalanib (Drug)
Stage 1 Dose Exploration 1 - Gemcitabine 850 + vatalanib 1250
Gemcitabine 850 mg/m2 + vatalanib 1250 mg
干预措施: Gemcitabine (Drug)
Stage 1 Dose Explrtion2 - Gemcitabine850+vatalanib 2x250/2x500
Gemcitabine 850 mg/m2 + vatalanib 250 mg Q12 hours x 1 week then 500 mg Q12 hours thereafter
干预措施: Vatalanib (Drug)
Stage 1 Dose Explrtion2 - Gemcitabine850+vatalanib 2x250/2x500
Gemcitabine 850 mg/m2 + vatalanib 250 mg Q12 hours x 1 week then 500 mg Q12 hours thereafter
干预措施: Gemcitabine (Drug)
Stage 2 Dose Expansion - Gemcitabine850+vatalanib 2x250/2x500
Gemcitabine 850 mg/m2 + vatalanib 250 mg Q12 hours x 1 week then 500 mg Q12 hours thereafter
干预措施: Vatalanib (Drug)
Stage 2 Dose Expansion - Gemcitabine850+vatalanib 2x250/2x500
Gemcitabine 850 mg/m2 + vatalanib 250 mg Q12 hours x 1 week then 500 mg Q12 hours thereafter
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Time-to-Treatment Failure (Intent-To-Treat Analysis)
时间窗: 12 months
For the purposes of an Intent-to-Treat (ITT) analysis, Time-to-Treatment Failure (TTF) was defined as the time from treatment initiation to treatment discontinuation for any reason, including disease progression, treatment toxicity, patient preference, lost-to-follow-up, or death. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0).
次要结局
- Time-to-Progression, Evaluable Patients(12 months)
研究者
George Albert Fisher
Associate Professor of Medicine
Stanford University