Yükleniyor... / Loading...
This study evaluates the drug PLB1001 compared with Temozolomide and other chemotherapy in patients with secondary glioblastoma or IDH-mutant glioblastoma (a brain tumor) that carries the ZM (PTPRZ1-MET) fusion gene. Patients previously treated with temozolomide and radiotherapy and positive for the PTPRZ1-MET fusion took part. It is being conducted in Phase 2/Phase 3; it is active but not currently recruiting.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: 1. histologically confirmed secondary glioblastoma,or glioblastoma with IDH mutantation 2. Must have evidence of PRPRZ1-MET fusion gene positivity from the result of molecular pre-screening evaluations 3. Prior treatment with temozolomide and radiotherapy 4. Stable or decreasing dose of corticosteroids within 5 days prior to the first dose 5. 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 6. Karnofsky performance score ≥ 60% 7. Pregnant or nursing women 8. Written consent Exclusion Criteria: 1. Previous or current treatment with a c-Met inhibitor or HGF-targeting therapy 2. Received antibody anti-tumor drug within 30 days before enrollment 3. Previous treatment with Camustine sustained release implant 4. The subject is unable to undergo MRI scan 5. Patients with active bleeding were found by brain CT or MRI scan before enrollment 6. Uncontrolled hypertension defined by a Systolic Blood Pressure (SBP) 150 mm Hg and/or Diastolic Blood Pressure (DBP) ≥100 mm Hg 7. Major surgery within 4 weeks prior to first dose of PLB1001 8. Pregnant or nursing women 9. Involved in other clinical trials \<30 days prior to first dose