A Phase II Study on Dose Optimization of Fruquintinib in Elderly Metastatic Colorectal Cancer Patients Refractory to Standard Treatment
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
A Phase II study on dose optimization of fruquintinib in elderly metastatic colorectal cancer patients refractory to standard treatment.
详细描述
This is a prospective, multi-center, single arm, phase II study. In this study, the low-dose initial dose incremental optimization scheme was used in the first cycle in patients ≥65 years old who need to receive fruquintinib. The aim is to observe the safety, tolerability and efficacy of fruquintinib in elderly patients with mCRC refractory to standard treatment. The correlation between the efficacy, toxicity and geriatric evaluation of fruquintinib will also be analysed.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •65 years and older;
- •Histologically or cytologically confirmed unresectable metastatic colorectal cancer refractory to or unfit for standard therapies;
- •ECOG PS 0-1;
- •At least 4 weeks after the last anti-tumor therapy (chemotherapy, radiotherapy, biotherapy or hormone therapy) and more than 3 months after operation treatment before enrollment;
- •Life expectancy ≥ 3 months;
- •Cooperative in observation of adverse events and curative effect;
- •No other anti-tumor concomitant treatment (including steroid drugs);
- •Adequate organ and bone marrow functions;
- •At least one measurable lesion(s);
- •Signed the written informed consent and completed the geriatric questionnaire (G8 screening form) at the time of enrollment.
排除标准
- •Active upper gastrointestinal ulcer, obvious vomiting, chronic diarrhea, intestinal obstruction, absorption disorder, etc which may affect drug absorption, distribution, metabolism, or clearance;
- •Evidence of central nervous system metastasis;
- •One of the following complications: uncontrolled hypertension, coronary artery disease, arrhythmia and heart failure;
- •Abuse of alcohol or drugs;
- •Less than 4 weeks from the last clinical trial;
- •Previous treatment with VEGFR inhibitors;
- •Severe uncontrolled disability with concurrent infection;
- •Proteinuria ≥ 2 + (1.0g / 24hr);
- •Uncontrollable gastrointestinal bleeding;
- •Arterial / venous thromboembolic events such as cerebrovascular accident (including transient ischemic attack) occurred within 12 months before the first dose;
- •Acute myocardial infarction, acute coronary syndrome or coronary artery bypass grafting occurred within 6 months before the first dose;
- •Fracture or wound that has not been cured for a long time;
- •Coagulation dysfunction, bleeding tendency or receiving anticoagulation treatment;
- •Congenital or acquired immune deficiency (such as HIV infection), or active hepatitis (HBV DNA ≥ 103copies / ml after regular antiviral therapy);
- •Patients who are not suitable for the study judged by the researchers.
研究组 & 干预措施
Fruquintinib dose-optimization
Fruquintinib was administered orally on 21 consecutive days in a 28-day treatment cycle. All patients were dose-optimized for the first cycle of fruquintinib - oral fruquintinib 3 mg/day in the first week; if tolerated, oral fruquintinib 4 mg/day in the second week; if still tolerated, then the dose was increased to 5 mg/day in the third week. From the second cycle, patients were given the maximum dose that they have tolerated in the first cycle.
干预措施: Fruquintinib (Drug)
结局指标
主要结局
PFS
时间窗: about a year
Progression-free survival is determined from the date of treatment to PD or death from any cause
次要结局
- ORR(about a year)
- Safety and tolerability(about a year)
- DCR(about a year)
- OS(about a year)
- Correlation between geriatric assessment and efficacy and safety(about a year)
研究者
Zhen-Yu Ding
Professor
Sichuan University