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A Study of PLB1001 Enteric Capsules in the Treatment of sGBM/IDH Mutant Glioblastoma Patients With the ZM Fusion Gene (FUGEN).
Sponsor: Beijing Pearl Biotechnology Limited Liability Company
Summary
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: 1. To evaluate overall survival (OS) in the treatment of secondary glioblasts with positive recurrence of PTPRZ1-MET (ZM) fusion gene by PLB1001 Enteric Capsules. 2. 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 1. Be given PLB1001 300mg BID,oral who were randomly assigned in test group. 2. Be given Temozolomide capsules ,oral, who were randomly assigned in control group. 3. Be given EP, ivgtt, who were randomly assigned in control group.
Official title: 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).
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
84
Start Date
2018-10-08
Completion Date
2026-12-31
Last Updated
2026-01-20
Healthy Volunteers
No
Conditions
Interventions
PLB1001
PLB1001 is a capsule in the form of 300mg,twice daily.
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
Locations (1)
Beijing Tiantan Hospital,Capital Medical University
Beijing, Beijing Municipality, China