A Phase II, Double Blind, Placebo Controlled, Randomised Study to Assess the Efficacy and Safety of 2 Doses of ZACTIMA™(ZD6474) in Combination With FOLFIRI vs FOLFIRI Alone for the Treatment of Colorectal Cancer in Patients Who Have Failed Therapy With an Oxaliplatin and Fluoropyrimidine Containing Regimen
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Number of Patients With an Objective Disease Progression Event
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of 2 doses of ZACTIMA™ (ZD6474) in combination with FOLFIRI vs FOLFIRI alone for the treatment of colorectal cancer in patients who have failed therapy with an oxaliplatin and fluoropyrimidine containing regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Histologically confirmed colorectal cancer
- •Have failed therapy with an oxaliplatin and fluoropyrimidine containing regimen defined as:
- •Progression on or following treatment for metastatic colorectal cancer
- •Progression within 12 months of adjuvant chemotherapy for colorectal cancer
排除标准
- •Previous treatment with small molecule tyrosine kinase inhibitors of VEGFR or EGFR eg, erlotinib, gefitinib. Prior monoclonal antibodies are permitted, eg, cetuximab, bevacizumab.
- •Previous adjuvant therapy with irinotecan within 12 months of randomization
- •More than one prior course of chemotherapy for treatment of metastatic colorectal cancer.
研究组 & 干预措施
1
FOLFIRI + placebo vandetanib
干预措施: FOLFIRI (Drug)
2
FOLFIRI + low dose vandetanib
干预措施: Vandetanib (Drug)
2
FOLFIRI + low dose vandetanib
干预措施: FOLFIRI (Drug)
3
FOLFIRI + high dose vandetanib
干预措施: Vandetanib (Drug)
3
FOLFIRI + high dose vandetanib
干预措施: FOLFIRI (Drug)
结局指标
主要结局
Number of Patients With an Objective Disease Progression Event
时间窗: Tumour assessments carried out at screening and then as per site clinical practice until objective progression. The only additional mandatory tumour assessment visit is at the point of data cut-off (28 March 2008 +/-3 days)
Number of patients with objective disease progression or death (by any cause in the absence of objective progression)
次要结局
未报告次要终点