A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Trial to Compare the Efficacy and Safety of Fruquintinib Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Patients With Colorectal Cancer as 3rd or Above Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
Fruquintinib administered at 5mg once daily in 4 weeks treatment cycle (three weeks on and one week off) was well tolerated and demonstrated encouraging preliminary clinical antitumor activity in patients with advanced Colorectal Cancer (CRC) in Phase Ib study.
This study is aimed to evaluate the efficacy and safety of Fruquintinib in the treatment of patients with metastatic CRC who have progressed after metastatic CRC second line or above standard chemotherapy.
详细描述
This is a randomized, double-blind, placebo-controlled, multicenter Phase II clinical trial to compare the efficacy and safety of Fruquintinib plus Best Supportive Care (BSC) versus placebo plus BSC in patients with metastatic colorectal cancer who have progressed after second-line or above standard chemotherapy.
After checking eligibility criteria, subjects will be randomized into Fruquintinib plus BSC group (treatment group) or placebo plus BSC group (control group) in a ration of 2:1.
Primary Efficacy Endpoint:
Progression free survival (PFS) (According to RECIST Version 1.1).
Secondary Efficacy Endpoints:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •≥ 18 and ≤ 75 years of age , with ≥ 40 Kg
- •Histological or cytological confirmed metastatic colorectal cancer
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- •Failed 2 or more lines of chemotherapy
- •Adequate hepatic, renal, heart, and hematologic functions
- •At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan)
- •Signed and dated informed consent.
- •Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure
排除标准
- •Pregnant or lactating women
- •Any factors that influence the usage of oral administration
- •Central nervous system (CNS) metastasis
- •One of the following conditions: non-controlled 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 inhibition
- •Disability of serious uncontrolled intercurrence infection
- •Proteinuria ≥ 2+ (1.0g/24hr)
- •Evidence or a history of bleeding tendency within two months of the enrollment, regardless of seriousness
- •History of artery/venous thromboembolic events in 12 months, such as cerebral vascular accident (including transient ischemic attack) etc.
- •History of acute myocardial infarction, acute coronary syndrome or coronary artery bypass graft (CABG) in 6 months
- •Bone fracture or wounds that was not cured for a long time
- •Coagulation dysfunction, hemorrhagic tendency or receiving anticoagulant therapy
研究组 & 干预措施
treatment arm
treatment arm- subjects will receive Fruquintinib 5mg orally, once daily (QD), plus BSC for 3 wks on/ 1 wk off. Patients will receive a cycles of 4 weeks of study treatment (1 cycle of study treatment includes 3 weeks of treatment and 1 week of drug discontinuation) or until the occurrence of progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or other conditions that meet the end of treatment criteria.
干预措施: fruquintinib (Drug)
control arm
control arm- subjects will receive Fruquintinib placebo 5mg orally, once daily (QD), plus BSC for 3 wks on/ 1 wk off. Patients will receive a cycles of 4 weeks of study treatment (1 cycle of study treatment includes 3 weeks of treatment and 1 week of drug discontinuation) or until the occurrence of progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or other conditions that meet the end of treatment criteria.
干预措施: placebo (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: From randomization until the date of first documented progression or date of death from any cause, whichever came first.
PFS refers to the time interval between the randomization date and the initial record of PD or date of death, whichever is earlier. The presence of PD shall be determined in accordance with the result of the evaluation performed by the investigator, using with RECIST v1.1 criteria. The date of final tumor evaluation will be used as the censoring date for subjects who have not presented with disease progression or death by that date. The date of randomization will be used as the censoring date for subjects which have no death and post-baseline tumor evaluation. If a subject has no post-baseline tumor evaluation but recorded as dead, death will be count as PFS event.
次要结局
- Disease Control Rate (DCR)(From randomization up to progressive disease or EOT due to any cause.)
- Over Survival (OS)(From randomization until death due to any cause.)
- Objective Response Rate (ORR)(From randomization up to progressive disease or end of treatment (EOT) due to any cause.)