NCT02489214终止1 期
A Phase 1B Study of Donafenib Monotherapy for Previously Treated Metastatic Gastric Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Number of Participants with Adverse Events
研究概览
简要总结
This open-label, one-center, noncomparative, two-stage phase 1B trial assessed the donafenib in advanced gastric cancer.
详细描述
This open-label, one-center, noncomparative, two-stage phase 1B trial assessed the tyrosine kinase inhibitor donafenib tosilate tablets (400 mg/d,200mg bid) in patients with advanced, inoperable gastric cancer progressing after chemotherapy . The primary endpoint is the safety.The secondary endpoints are tumor response and progression-free survival time.
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
- •All patients provided written, informed consent.
- •Have histological or cytological documentation of gastric adenocarcinoma;
- •Have received currently approved standard therapies and to have disease progression during or within 3 months after the last administration of the last standard therapy or to have stopped standard therapy because of unacceptable toxic effects.
- •Standard therapies include as many of the following as were licensed: a fluoropyrimidine,oxaliplatin,irinotecan, paclitaxel,docetaxel;and trastuzumab for patients who had Her-2 positive tumours;
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- •Life expectancy of at least 3 months;
- •Have adequate bone-marrow, liver, and renal function at the start of the trial.
- •Prothrombin time international normalized ratio≤1.5；
排除标准
- •Patients with brain metastases.
- •Patients receiving cytotoxic chemotherapy, immunotherapy or hormonal therapy, radiotherapy to site of measurable or evaluable disease within the previous 4 weeks.
- •Patients had evidence of clinically active interstitial lung disease or abnormal blood results by predefined criteria (serum bilirubin >1.5 times upper limit of reference range, aspartate or alanine aminotransferase>2.5 times the upper limit of normal if no demonstrable liver disease).
研究组 & 干预措施
donafenib tosilate tablets
Experimental
200mg bid
干预措施: donafenib tosilate tablets (Drug)
结局指标
主要结局
Number of Participants with Adverse Events
时间窗: 54 weeks
patients with adverse events/all patients\*100%
次要结局
- Tumor response(54 weeks)
- Progression-free survival time(54 weeks)
研究者
研究点 (2)
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