Phase 1c Single Arm Study of Thioredoxin Reductase Inhibitor Ethaselen, for the Treatment of Thioredoxin Reductase High Expressed Advanced Non-small Cell Lung Cancers Who Have Received More Than Two Lines Standard Treatment.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 6 week disease control rate
研究概览
简要总结
Thioredoxin reductase plays an critical role in lung cancer patients, in vitro study showed that, ethaselen, specific inhibitor of thioredoxin reductase, could inhibit lung cancer cell growth and induce apoptosis. In China, phase 1 clinical trials of ethaselen showed that 1200 mg dose ethaselen could be well tolerated, in pre-clinical study we found that, approximately 50% non-small cell lung cancers harbored high thioredoxin reductase expression(IHC result ++ or +++), phase 1a/b of ethaselen had finished in 2008, the result showed that 1200mg ethaselen per day was safety and tolerated by Chinese malignant tumor patients.In pre-clinical research, our group found that, elevated of thioredoxin reductase activity was associated with the expression of thioredoxin reductase tested by immunohistochemistry, which means high expression of this enzyme may be a favourite predicted factor of ethaselen, the specific inhibitor of thioredoxin reductase.
详细描述
This phase 1c study will include patients pathologic diagnosis advanced non-small cell lung cancer who had received more than two lines standard treatment, according to NCCN Non-small cell lung cancer guideline, there were no standard treatment scheme for these patients. Approximately 40 patients will be included in the study, patients will received oral ethaselen dispersible tablet, 600 mg bid dose, primary endpoint of this study is 6 week disease control rate(DCR, CR+PR+SD), secondary endpoints include progression free survival(PFS), overall survival(OS), quality of life(QOL) and drug safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •advanced non-small cell lung cancer, stage IIIB/IV who had received more than 2 standard treatment scheme
- •18-75 years old, anticipate overall survival more than 3 months, ECOG 0-2
- •within 4 weeks, not receive chemotherapy, radiotherapy or surgery
- •HB≥90g/L； ANC ≥1.5×109/L；PLT ≥80×109/L
- •EGFR/ALK mutation negative
- •immunohistochemistry test of cancer tissue showed ++ or +++ of thioredoxin reductase
- •brain metastasis without symptoms
排除标准
- •according to NCCN non-small cell lung cancer guidelines (2014 v3), there were standard treatment scheme for the patients
- •pregnancy or breast-feeding women
- •any serious disease which could not be controled
- •urine protein≥++, or 24h urine protein>1g
- •received any anti-cancer treatment within 4 weeks
研究组 & 干预措施
experimental
patients pathologic diagnosis advanced non-small cell lung cancer who had received more than two lines standard treatment, according to NCCN Non-small cell lung cancer guideline, there were no standard treatment scheme for these patients. Approximately 40 patients will be included in the study, patients will received oral ethaselen dispersible tablet, 600 mg bid dose, patients may quit the study whenever they would like or investigator evaluate that progression disease has developed, or any grade of SAE developed during the study.
干预措施: ethaselen (Drug)
结局指标
主要结局
6 week disease control rate
时间窗: within 6 weeks after patients received ethaselen treatment
disease control rate will be measured within 6 weeks after patients received ethaselen treatment
次要结局
- progression free survival(the first time investigator evaluate PFS will be at the sixth week since the study begin, the second time investigator evaluate PFS will be at the 12th week, the next time will be at the 18th week.)
- safety of drug(safety of drug will be recorded during treatment, up to 6 weeks after treatment)
- overall survival(the first time investigator evaluate OS will be at the sixth week since the study begin, the second time investigator evaluate PFS will be at the 12th week, the next time will be at the 18th week. Up to 30 weeks after the study was finished.)
研究者
Yongchang Zhang
Director of department of medical oncology, lung cancer and gastrointestinal cancer unit
Hunan Province Tumor Hospital