A Randomized, Controlled, Open, Multicenter, Phase II/III Clinical Study to Evaluate the Safety and Efficacy of Vebreltinib Enteric Capsules in the Treatment of sGBM/IDH Mutant Glioblastoma Patients With the ZM Fusion Gene (FUGEN).
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Overall survival(OS)
研究概览
简要总结
The goal of this clinical trial is to evaluate the safety and efficacy of PLB1001 Enteric Capsules in the treatment of PTPRZ1-MET fusion gene positive recurrent secondary glioblastoma. The main questions it aims to answer are:
- To evaluate overall survival (OS) in the treatment of secondary glioblasts with positive recurrence of PTPRZ1-MET (ZM) fusion gene by PLB1001 Enteric Capsules.
- To evaluate if it is safety and tolerant in the treatment of secondary glioblasts with positive recurrence of PTPRZ1-MET (ZM) fusion gene by PLB1001 Enteric Capsules.
Participants will
- Be given PLB1001 300mg BID,oral who were randomly assigned in test group.
- Be given Temozolomide capsules ,oral, who were randomly assigned in control group.
- Be given EP, ivgtt, who were randomly assigned in control group.
详细描述
84 sGBM or IDH mutant glioblastoma patients with the ZM fusion gene will be randomly divided into group A (receive vebreltinib) or group B ( receive investigator choose), and the randomize ratio will be 1:1, patients in group A will receive PLB1001 300mg Bid, 28days/cycle. Patients in group B will receive temozolomide (100-150mg/m2/d, 7 days 1 to7 and days 15 to 22 of each 28-day cycle ) or cisplatin+etoposide(cisplatin:80-100mg/m2/3 days, 28days/cycle; etoposide:100mg/m2/d, 3days, 28 days/cycle).
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologically confirmed secondary glioblastoma,or glioblastoma with IDH mutantation
- •Must have evidence of PRPRZ1-MET fusion gene positivity from the result of molecular pre-screening evaluations
- •Prior treatment with temozolomide and radiotherapy
- •Stable or decreasing dose of corticosteroids within 5 days prior to the first dose
- •Platelet count≥75×109/L,Neutrophilic granulocyte count≥1.5×109/L, Hemoglobin>90g/L,AST or ALT < 3 times the lab's upper normal limit,Serum creatinine < 1.5 times the lab's upper normal limit,INR≤2.0
- •Karnofsky performance score ≥ 60%
- •Pregnant or nursing women
- •Written consent
排除标准
- •Previous or current treatment with a c-Met inhibitor or HGF-targeting therapy
- •Received antibody anti-tumor drug within 30 days before enrollment
- •Previous treatment with Camustine sustained release implant
- •The subject is unable to undergo MRI scan
- •Patients with active bleeding were found by brain CT or MRI scan before enrollment
- •Uncontrolled hypertension defined by a Systolic Blood Pressure (SBP) 150 mm Hg and/or Diastolic Blood Pressure (DBP) ≥100 mm Hg
- •Major surgery within 4 weeks prior to first dose of PLB1001
- •Pregnant or nursing women
- •Involved in other clinical trials <30 days prior to first dose
研究组 & 干预措施
PLB1001
Subjects will receive 300mg of PLB1001 twice daily in cycles of 4 weeks duration until death or adverse event(AE) leading to discontinuation
干预措施: PLB1001 (Drug)
Temozolomide or Cisplatin combined with etoposide
Investigators can choose one of two treatments
- Dose density of temozolomide：100-150mg/m2/d,day 1 to 7 and day 15 to 22 of each 28-day cycle
- Cisplatin combined with etoposide：Cisplatin,80-100mg/m2/3 days,28 days/cycle.etoposide, 100mg/m2/d,3 days,28 days/cycle
干预措施: Temozolomide (Drug)
Temozolomide or Cisplatin combined with etoposide
Investigators can choose one of two treatments
- Dose density of temozolomide：100-150mg/m2/d,day 1 to 7 and day 15 to 22 of each 28-day cycle
- Cisplatin combined with etoposide：Cisplatin,80-100mg/m2/3 days,28 days/cycle.etoposide, 100mg/m2/d,3 days,28 days/cycle
干预措施: Cisplatin combined with Etoposide (Drug)
结局指标
主要结局
Overall survival(OS)
时间窗: 5 years
Overall survival is defined as the time(in months)from random to the date of death.
次要结局
- Progression Free Survival evaluated by Investigator(PFS)(5 years)
- Objective Response Rate Evaluated by Investigator(ORR)(5 years)
- Quality of Life Assessment EORTC-QLQ-C30(5 years)
- Karnofsky Performance Status score(5 years)
- Quality of Life Assessment EORTC-QLQ-BN20(5 years)