An Open-label, Phase II Trial of ZD1839 (IRESSA) in Patients With Malignant Mesothelioma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 23
- 主要终点
- To assess the activity of ZD1839 in patients with malignant mesothelioma by estimating the objective response rate (CR and PR) at trial closure
研究概览
简要总结
This study is a multicentre, open label, non-comparative, two stage phase II trial to assess the activity of ZD1839 (IRESSA) in patients with malignant mesothelioma. Patients will receive trial treatment as first-line therapy, administered continuously once daily until the completion of six 4-week cycles of treatment, disease progression, unacceptable toxicity or withdrawal of consent. Patients continuing to show evidence of response, disease stabilization or clinical benefit from ZD1839 may continue to receive therapy beyond completion of the trail.
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
- •Histologically-confirmed malignant mesothelioma (based on pleural biopsy); eligibility for first line therapy for malignant mesothelioma
- •Uni or bi- dimensionally measurable disease
- •No prior radiotherapy within 3 weeks of enrolment into the trial
- •No significant comorbid disease
排除标准
- •Other malignancies, either co-existing or diagnosed within the last 5 years, with the exception of basal cell carcinoma or cervical cancer in situ
- •Brian metastasis or leptomeningeal carcinomatosis
- •Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy
- •Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, or St. John's Wort
研究组 & 干预措施
1
干预措施: ZD1839 (Drug)
结局指标
主要结局
To assess the activity of ZD1839 in patients with malignant mesothelioma by estimating the objective response rate (CR and PR) at trial closure
时间窗: Proportion of patients responding at trial closure, ITT population
To further characterize the safety profile of ZD1839 at a 250mg daily dose
时间窗: Proportion of patients responding at trial closure, ITT population
次要结局
- To estimate PFS (progression free survival)(Proportion of patients alive and progression-free at trial closure, ITT population; Median time to progression or death; Proportion of patients alive and progression-free at 6 months)
- To estimate overall survival(Proportion of patients alive at trial closure, ITT population; Median time to death; Proportion of patients alive at 6 months)
- To estimate duration of response(Median time from objective response to progression or death; only patients who responded are included in this analysis)