An Open Label Phase II Multicentre Clinical Trial of Single Agent Bortezomib in Patients With Malignant Pleural Mesothelioma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 13
- 主要终点
- Objective tumor response rate (complete response or partial response) as assessed by modified RECIST criteria
研究概览
简要总结
RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying the side effects of bortezomib and how well it works in treating patients with malignant pleural mesothelioma.
详细描述
OBJECTIVES:
Primary
- Assess the clinical efficacy of bortezomib based on the evaluation of objective tumor response rate.
Secondary
- Assess additional clinical efficacy of bortezomib based on the evaluation of time to early disease progression and median overall 2-year survival rate.
- Assess safety and toxicity in these patients.
- Assess quality of life using the Lung Cancer Symptom Score.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Bortezomib 1.6mg/m2
干预措施: bortezomib (Drug)
Bortezomib 1.6mg/m2
干预措施: quality-of-life assessment (Procedure)
结局指标
主要结局
Objective tumor response rate (complete response or partial response) as assessed by modified RECIST criteria
时间窗: 28 days prior to baseline, at 10 weeks and at end of treatment
The objective tumour response rate is a primary endpoint of the study. This will be a proportion of evaluable subjects who achieve a confirmed CR or PR per modified RECIST guidelines within four cycles (20 weeks) of treatment.
次要结局
- Safety(The assessment of safety will be based mainly on the frequency of adverse events and on the number of laboratory values that fall outside of the pre-determined normal ranges.)
- Overall survival(Overall Survival is measured from the date of first treatment to the date of the subject's death. If the subject is alive or the vital status is unknown, the date of death will be censored at the date that the subject is last known to be alive.)
- Quality of life(Week 1, Week 10 and end of treatment)
- Time to disease progression(Time to disease progression is measured from first treatment until the date of PD or death whichever is first reported. Subjects who did not progress or die will be censored at the day of their last tumour assessment.)