Status:
UNKNOWN
A Study of PLB1001 Enteric Capsules in the Treatment of sGBM/IDH Mutant Glioblastoma Patients With the ZM Fusion Gene (FUGEN).
Lead Sponsor:
Beijing Pearl Biotechnology Limited Liability Company
Conditions:
Glioblastoma
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief 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 questi...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT06105619
Start Date
October 8 2018
End Date
December 31 2024
Last Update
October 31 2023
Active Locations (1)
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1
Beijing Tiantan Hospital,Capital Medical University
Beijing, Beijing Municipality, China, 100070