NCT03274882已完成2 期
Open-label Multicentre Confirmatory Study of Efficacy and Safety of S 95005 (TAS-102) in Patients With Metastatic Colorectal Cancer Who Are Refractory or Intolerant to Standard Chemotherapies
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Progression free survival (PFS) rate
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of S 95005 in patients with metastatic colorectal cancer (mCRC) who are refractory or intolerant to standard chemotherapies in terms of Progression-Free Survival rate at 2 months in the Russian population.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged ≥18 years of age
- •Has definitive histologically or cytologically confirmed adenocarcinoma of the colon or rectum
- •Has received at least 2 prior regimens of standard chemotherapies for metastatic colorectal cancer (including fluoropyrimidines, irinotecan and oxaliplatin and, if accessible, an anti-VEGF monoclonal antibody and at least one of the anti-EGFR monoclonal antibodies for RAS wild-type patients (if RAS mutation status was evaluated)) and was refractory or intolerant to those chemotherapies
- •Has Eastern Cooperative Group (ECOG) performance status of 0 or 1
- •Has at least one measurable metastatic lesion(s)
- •Has adequate organ function
- •Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use a highly effective method of birth control during the study and for 6 months after the discontinuation of study medication
排除标准
- •Pregnancy, breastfeeding
- •Participation in another interventional study within 4 weeks prior to inclusion; participation in non-interventional registries or epidemiological studies is allowed
- •Has previously received S95005 or history of allergic reaction attributed to compounds of similar composition to S95005
- •Has a serious illness or medical condition(s) as described in the protocol
- •Has had certain other recent treatment e.g. major surgery, field radiation, anticancer therapy, within the specified time frames prior to inclusion
- •Has unresolved toxicity of greater than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 attributed to any prior therapies.
研究组 & 干预措施
S95005
Experimental
Film-coated tablet containing 15 mg of trifluridine and 7.065 mg of tipiracil hydrochloride, or 20 mg of trifluridine and 9.42 mg of tipiracil hydrochloride (with a molar ratio of 1:0.5) was administered at 35 mg/m²/dose orally twice a day, within 1 hour after completion of morning and evening meals, for 5 days on/2 days off, over 2 weeks, followed by a 14-day rest period. This treatment cycle was repeated every 4 weeks until treatment withdrawal criteria are met.
干预措施: S95005 (Drug)
结局指标
主要结局
Progression free survival (PFS) rate
时间窗: at 2 months
percentage of patients alive without investigator-assessed radiological disease progression according to RECIST 1.1 after 2 months
次要结局
- Progression-Free Survival (PFS).(Through study completion, an average of 12 weeks)
- Overall Response Rate (ORR).(Through study completion, an average of 12 weeks)
- Disease Control Rate (DCR)(Through study completion, an average of 12 weeks)
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](Through study completion, an average of 12 weeks)
- Abnormalities in physical examination and performance status (ECOG) [safety and tolerability](Through study completion, an average of 12 weeks)
- Abnormalities in laboratory tests (haematology, blood biochemistry and urinalysis) [safety and tolerability](Through study completion, an average of 12 weeks)
- Abnormalities in respiration rate [safety and tolerability](Through study completion, an average of 12 weeks)
- Abnormalities in blood pressure [safety and tolerability](Through study completion, an average of 12 weeks)
- Abnormalities in heart rate [safety and tolerability](Through study completion, an average of 12 weeks)
- Abnormalities in body temperature [safety and tolerability](Through study completion, an average of 12 weeks)
- Abnormalities in body weight [safety and tolerability](Through study completion, an average of 12 weeks)
- Abnormalities in 12-leads ECG parameters [safety and tolerability](Through study completion, an average of 12 weeks)
研究者
研究点 (2)
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