A Study of PLB1001 Enteric Capsules in the Treatment of sGBM/IDH Mutant Glioblastoma Patients With the ZM Fusion Gene (FUGEN). - Trial NCT06105619
Access comprehensive clinical trial information for NCT06105619 through Pure Global AI's free database. This Phase 2/3 trial is sponsored by Beijing Pearl Biotechnology Limited Liability Company and is currently Recruitment Completed. The study focuses on Glioblastoma. Target enrollment is 84 participants.
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Study Focus
Sponsor & Location
Beijing Pearl Biotechnology Limited Liability Company
Timeline & Enrollment
Phase 2/3
Oct 08, 2018
Dec 31, 2024
Primary Outcome
Overall survival(OS)
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06105619
Non-Device Trial