A Phase Ib Study of Varlitinib in Japanese Subjects With Advanced or Metastatic Solid Tumours
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- The number of patients with a dose limiting toxicity (DLT) in the first treatment cycle
研究概览
简要总结
The purpose of this study is to explore safety and efficacy of varlitinib administered as monotherapy in Japanese subjects with advanced or metastatic solid tumors, and administered as combination with capecitabine in Japanese subjects with advanced or metastatic biliary tract cancer. Also to evaluate pharmacokinetics (PK) of varlitinib, capecitabine and its metabolite.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Study I: Subjects with a solid tumour (excluding haematologic tumors) in advanced or metastatic stage
- •Study II: Subjects with advanced (unresectable) or metastatic biliary tract cancer (IHCC, EHCC, gallbladder cancer or ampullary carcinoma)
排除标准
- •Subjects with concurrent multiple primary cancers.
- •Subjects with a history of (non-infectious) pneumonitis that required steroids or current pneumonitis, or with a history of interstitial lung disease or current interstitial lung disease
- •Subjects receiving proton pump inhibitors for established, symptomatic gastro-duodenal ulceration or gastroesophageal reflux disease (including the preventive use)
研究组 & 干预措施
Study II
Varlitinib given in combination with capecitabine to Japanese subjects with advanced or metastatic biliary tract cancer
干预措施: varlitinib (Drug)
Study I
Varlitinib given as monotherapy to Japanese subjects with advanced or metastatic solid tumors
干预措施: varlitinib (Drug)
Study II
Varlitinib given in combination with capecitabine to Japanese subjects with advanced or metastatic biliary tract cancer
干预措施: capecitabine (Drug)
结局指标
主要结局
The number of patients with a dose limiting toxicity (DLT) in the first treatment cycle
时间窗: 3 weeks
Determine the DLT(Dose Limiting Toxicity) and MTD(Maximum Tolerated Dose) or Recommended Phase II Dose (RP2D) in Phase I setting.
时间窗: 52 weeks
次要结局
- Pharmacokinetics: varlinitib, capecitabine and 5-FU metabolites levels in terms of Peak Plasma Concentration (Cmax)(Through, Day 1, Day 3, Day 22)
- Pharmacokinetics: varlinitib, capecitabine and 5-FU metabolites levels in terms of Area under the plasma concentration-time curve (AUC) from 0 to 12 hours (AUC0-12)(Through, Day 1, Day 3, Day 22)
- Pharmacokinetics: varlinitib, capecitabine and 5-FU metabolites levels in terms of Minimum (trough) plasma concentration (Cmin)(Through, Day 1, Day 3, Day 22)
- Pharmacokinetics: varlinitib, capecitabine and 5-FU metabolites levels in terms of Elimination half-life of Phase β (t1/2β)(Through, Day 1, Day 3, Day 22)