NCT00506051已完成1 期
A Phase I, Open-Label Study to Assess the Safety and Tolerability of ZD6474 in Combination With Pemetrexed (Alimta) in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer After Failure of Prior Chemotherapy.
Genzyme, a Sanofi Company0 个研究点目标入组 21 人开始时间: 2005年7月最近更新:
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
- 入组人数
- 21
- 主要终点
- To establish the safety & tolerability of ZD6474 when administered in combination w/Pemetrexed (Alimta) to patients w/locally advanced or metastatic NSCLC after failure of prior chemo, by assessment of AEs, vital signs, lab, ECG and physical exam.
研究概览
简要总结
The main purpose of this trial is to look to see if adding ZD6474 (100 mg or 300mg tablets) to Alimta chemotherapy in patients with non-small cell lung cancer is safe and will help control their symptoms and disease better than the chemotherapy alone.
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 advanced or metastatic non-small cell lung cancer
- •Failure of first-line chemotherapy
- •1 or more measurable lesion by RECIST
排除标准
- •Previous chemotherapy or radiotherapy within 4 weeks
- •Significant cardiac events, arrythmias or other cardiac conditions
- •Unacceptable laboratory measurements
研究组 & 干预措施
ZD6474 (vandetanib) 100mg
Experimental
干预措施: ZD6474 (vandetanib) 100mg (Drug)
ZD6474 (vandetanib) 100mg
Experimental
干预措施: pemetrexed (Drug)
ZD6474 (vandetanib) 300mg
Experimental
干预措施: pemetrexed (Drug)
ZD6474 (vandetanib) 300mg
Experimental
干预措施: ZD6474 (vandetanib) 300mg (Drug)
结局指标
主要结局
To establish the safety & tolerability of ZD6474 when administered in combination w/Pemetrexed (Alimta) to patients w/locally advanced or metastatic NSCLC after failure of prior chemo, by assessment of AEs, vital signs, lab, ECG and physical exam.
时间窗: assessed at each visit
次要结局
- To investigate the pharmacokinetics of ZD6474 and Pemetrexed when given in combination to patients with locally advanced or metastatic NSCLC after failure of prior chemotherapy, by assessment of appropriate pharmacokinetic (PK) parameters.(assessed at each visit)
研究者
相似试验
已完成
1 期
Safety and Tolerability Study of AZD2171 in Combination With AZD0530 in Patients With Advanced Solid TumoursNeoplasmsNCT00475956AstraZeneca40
已完成
1 期
Open Label, Phase I ZD6474 Head and Neck Cancer StudyHead and Neck CancerNCT00450138Sanofi48
已完成
1 期
Investigate the Safety and Tolerability of AZD6244 Monotherapy or + Docetaxel in Japanese Patients With Advanced Solid Malignancies or Non-Small Cell Lung CancerNeoplasms,Metastatic Cancer,Advanced Solid MalignanciesNon-Small Cell Lung CancerNCT01605916AstraZeneca33
已完成
2 期
A Study To Assess ZD6474 (ZACTIMA™) Monotherapy In Locally Advanced or Metastatic Hereditary Medullary Thyroid CancerThyroid CancerNCT00358956Genzyme, a Sanofi Company19
已完成
1 期
Study to Assess the Safety and Preliminary Efficacy of AZD0156 at Increasing Doses Alone or in Combination With Other Anti-cancer Treatment in Patients With Advanced CancerAdvanced Solid TumoursNCT02588105AstraZeneca84