NCT01576380已完成2 期
A Single-arm, Multi-center, Phase II Study to Evaluate Efficacy and Safety of Dovitinib (TKI258) in Adult Patients With Advanced Scirrhous Gastric Carcinoma That Have Progressed After One or Two Prior Systemic Treatments
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- disease control rate (DCR)
研究概览
简要总结
This is a prospective, open-label, single-arm, non-randomized, multi-center, phase II proof of concept (PoC) study with a two-stage design and Bayesian interim monitoring to evaluate efficacy and safety of single agent TKI258 in adult patients with scirrhous gastric carcinoma (SGC) that have progressed after one or two prior systemic treatments.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of advanced/metastatic scirrhous gastric carcinoma
- •Evidence of diffusely infiltrating gastric lesions and/or at least one measurable extra-gastric lesion
- •Patients previously treated with one or two systemic lines
- •Documented radiological confirmation of disease progression
- •ECOG performance status of 0 to 2
- •Male and female patients aged 20 years or greater
- •Adequate liver, renal, and hematologic function
排除标准
- •Patients who received prior treatment with an FGFR inhibitor
- •Patients with known brain metastases or who have signs/symptoms attributable to brain metastases and have not been assessed with radiologic imaging to rule out the presence of brain metastases
- •Patients with another primary malignancy within 3 years prior to starting study treatment
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
TKI258
Experimental
TKI258 is dosed on a flat scale of 500 mg, to be administered orally on a 5 days on / 2 days off dosing schedule which will be repeated every week.
干预措施: TKI258 (Drug)
结局指标
主要结局
disease control rate (DCR)
时间窗: up to 8 weeks after the start date of study treatment
Eight-week DCR is defined as the proportion of patients with best overall response of CR, PR or SD at the end of Week 8 as per local investigator's assessment.
次要结局
- progression free survival (PFS)(baseline and every 4 weeks until Week 17 and every 8 weeks after Week 17 until disease progress)
- Plasma concentrations of TKI258(Week 1 Day 1 - Day 2: pre-dose (0 hour), 1, 2, 4, 6, 8, and 24 hour (pre-dose). and Week 4 Day 5 - Week 5 Day 1: pre-dose (0 hour), 1, 2, 4, 6, 8, 24, 48, and 72 hour (pre-dose))
- time to progression (TTP)(baseline and every 4 weeks until Week 17 and every 8 weeks after Week 17 until disease progression)
- time to progression (TTP) per independent central review(baseline and every 4 weeks until Week 17 and every 8 weeks after Week 17 until disease progress)
- Safety and tolerability of TKI258(more than 30 days after the last date of study treatment)
- overall response rate (ORR)(baseline and every 4 weeks until Week 17 and every 8 weeks after Week 17 until disease progress)
- progression free survival (PFS) per independent central review(baseline and every 4 weeks until Week 17 and every 8 weeks after Week 17 until disease progress)
- overall survival (OS)(every 8 weeks until death)
- disease control rate (DCR) per independent central review(up to 8 weeks after the start date of study treatment)
- overall response rate (ORR) per independent central review(baseline and every 4 weeks until Week 17 and every 8 weeks after Week 17 until disease progress)
研究者
研究点 (1)
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