NCT00681798已完成1 期
Dose Escalation Study of the Combination of ZD6474, Gemcitabine and Capecitabine in Locally Advanced Unresectable or Metastatic Pancreatic Adenocarcinoma
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
- Sanofi
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Define Maximum Tolerated Dose (MTD)
研究概览
简要总结
The purpose of this study is to define th Maximum Tolerated Dose (MTD) and the recommended dose (RD) of ZD6474 in combination with a fixed standard dose of gemcitabine and capecitabine
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Confirmed diagnosis of locally advanced unresectable or metastatic pancreatic adenocarcinoma
- •ECOG performance status <1
- •Measurable disease
排除标准
- •Severe or uncontrolled systemic disease
- •Clinically significant cardiac event such as myocardial infarction
- •Any concomitant medication that may cause OTc prolongation, include Torsades de Pointes
研究组 & 干预措施
Dose level 4
Active Comparator
Vandetanib 300mg/day plus Gemcitabine plus CapectiabineDose
干预措施: Vandetanib (Drug)
Dose level 1
Active Comparator
Vandetanib 100mg/day plus Gemcitabine
干预措施: Vandetanib (Drug)
Dose level 2
Active Comparator
Vandetanib 300mg/day plus Gemcitabine
干预措施: Vandetanib (Drug)
Dose level 3
Active Comparator
Vandetanib 100mg/day plus Gemcitabine plus CapecitabineDose
干预措施: Vandetanib (Drug)
结局指标
主要结局
Define Maximum Tolerated Dose (MTD)
时间窗: during whole study
Define Recommended Dose (RD)
时间窗: during whole study
次要结局
- Evaluate safety profile(during whole study)
- Determine antitumour activity as determined by overall response rate (RR), progression free survival (PFS), disease control rate and duration of response(every 2 months)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Open Label, Phase I ZD6474 Head and Neck Cancer StudyHead and Neck CancerNCT00450138Sanofi48
已完成
1 期
A Dose Escalation Study of the Combination of Lenalidomide (Revlimid®), Dexamethasone and Cyclophosphamide in Patients Refractory or Relapsing From Stable Disease With Multiple MyelomaMultiple MyelomaNCT00915408King's College Hospital NHS Trust32
终止
1 期
First-In-Human (FIH) Study of W0180 as Single Agent and in Combination With Pembrolizumab in Adults With Locally Advanced or Metastatic Solid TumorsLocally Advanced or Metastatic Solid TumorsNCT04564417Pierre Fabre Medicament33
终止
1 期
Radiation Therapy (XRT) and ZD6474 in Non-Small Cell Lung Cancer (NSCLC)Non-Small Cell Lung CancerNCT00745732M.D. Anderson Cancer Center3
已完成
1 期
Oral SAR245408 (XL147) and Oral MSC1936369B in Patients With Locally Advanced or Metastatic Solid TumorsSolid TumorsNCT01357330Sanofi18