A Randomized Phase II Trial To Evaluate The Efficacy And Safety Of Vandetanib (ZD6474, ZACTIMA ™) Versus Vinorelbine In Patients With Inoperable Or Relapsed Malignant Mesothelioma.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Number of Participants With Disease Control.
研究概览
简要总结
A clinical study to assess if a new investigational drug is effective in treating malignant mesothelioma, compared to a chemotherapy treatment (Navelbine®). In this study the patients will be assigned by chance to receive either the new drug or a chemotherapy treatment (Navelbine®). Treatment will continue as long as the cancer does not worsen and the patient wishes to continue in the study. The study will recruit approximately 66 patients.
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
- 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
- •Diagnosed with mesothelioma
- •Previously treated with only one course of chemotherapy for mesothelioma
- •No previous treatment with vinorelbine
- •No serious heart problems within the last 3 months
排除标准
- •Serious abnormal laboratory values
- •Severe or uncontrolled disease or condition as judged by the Investigator
- •Pregnant or breast-feeding women
- •Other cancers within the last 5 years
- •Major surgery or radiation therapy within 4 weeks prior to starting study therapy
- •Receipt of any investigational agents within 30 days prior to commencing study treatment.
研究组 & 干预措施
1
Vinorelbine
干预措施: Vinorelbine (Drug)
2
Vandetanib
干预措施: Vandetanib (Drug)
结局指标
主要结局
Number of Participants With Disease Control.
时间窗: Assessed at 2 months.
Disease control is defined as having a complete response (CR), a partial response (PR) or stable disease (SD) according to the modified RECIST criteria for assessment of response in malignant pleural mesothelioma. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere and PR is defined as at least a 30% reduction in the total tumour measurement. A confirmed response requires a repeat observation on two occasions 4 weeks apart. PD is defined as an increase of at least 20% in the total tumour measurement over the nadir measurement, or the appearance of one or more new lesions. Patients with SD are those who fulfill the criteria for neither PR nor PD.
次要结局
- Progression-free Survival (PFS)(Assessed from baseline to 12 months.)
- Number of Participants With Objective Response.(Assessed at 2 months.)
- Overall Survival (OS)(Assessed from baseline to 12 months.)