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Trial Title:
A Study of PLB1001 Enteric Capsules in the Treatment of sGBM/IDH Mutant Glioblastoma Patients With the ZM Fusion Gene (FUGEN).
NCT ID:
NCT06105619
Condition:
Glioblastoma
Conditions: Official terms:
Glioblastoma
Etoposide
Temozolomide
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
PLB1001
Description:
PLB1001 is a capsule in the form of 300mg,twice daily.
Arm group label:
PLB1001
Other name:
Vebreltinib
Intervention type:
Drug
Intervention name:
Temozolomide
Description:
100-150mg/m2/d,day 1 to 7 and day 15 to 22 of each 28-day cycle
Arm group label:
Temozolomide or Cisplatin combined with etoposide
Intervention type:
Drug
Intervention name:
Cisplatin combined with Etoposide
Description:
Cisplatin:80-100mg/m2/3 days,28 days/cycle Etoposide:100mg/m2/d,3 days,28 days/cycle
Arm group label:
Temozolomide or Cisplatin combined with etoposide
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.
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 be 1:1, patients in group A will receive PLB1001 300mg Bid,
28days/cycle. Patients in group B will receive temozolomide (100-150mg/m2/d, 7 days 1 to7
and days 15 to 22 of each 28-day cycle ) or cisplatin+etoposide(cisplatin:80-100mg/m2/3
days, 28days/cycle; etoposide:100mg/m2/d, 3days, 28 days/cycle).
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Tiantan Hospital,Capital Medical University
Address:
City:
Beijing
Zip:
100070
Country:
China
Start date:
October 8, 2018
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Beijing Pearl Biotechnology Limited Liability Company
Agency class:
Industry
Source:
Beijing Pearl Biotechnology Limited Liability Company
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06105619
