A Study of PLB1001 Enteric Capsules in the Treatment of sGBM/IDH Mutant Glioblastoma Patients Wit… (NCT06105619) | Clinical Trial Compass
Active — Not RecruitingPhase 2/3
A Study of PLB1001 Enteric Capsules in the Treatment of sGBM/IDH Mutant Glioblastoma Patients With the ZM Fusion Gene (FUGEN).
China84 participantsStarted 2018-10-08
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. Previous or current treatment with a c-Met inhibitor or HGF-targeting therapy
✕
What they're measuring
1
Overall survival(OS)
Timeframe: 5 years
Trial details
NCT IDNCT06105619
SponsorBeijing Pearl Biotechnology Limited Liability Company