Vebreltinib Combined With Temozolomide for Glioblastoma (GBM) After Surgery
NCT ID: NCT06780592
Last Updated: 2025-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
60 participants
INTERVENTIONAL
2025-01-13
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
The plan is to recruit 60 eligible subjects and assign them to either the control group (standard TMZ 5/28 therapy) or the experimental group (TMZ plus LEV Vebreltinib) at a 1:1 ratio. Participants will undergo a 48-week treatment period and a 2-year follow-up period.. The study is expected to commence recruitment in mainland China in about Aug 2024. It is expected that the trial will end in December 2025.
TREATMENT
NONE
Study Groups
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Vebreltinib + Temozolomide
Participants received Vebreltinib (300 mg Bid) in combination with Temozolomide (150 mg/m2) treatment, every 4 weeks for up to 6 cycles (Induction).
Vebreltinib + Temozolomide
Vebreltinib is a capsule in the form of 25 mg and 100mg, twice daily. Participants received Vebreltinib (300 mg Bid) in combination with Temozolomide (150 mg/ m2) treatment, every 4 weeks for up to 6 cycles (Induction).
Temozolomide
Participants received Temozolomide (150 mg/m2) treatment, every 4 weeks for up to 6 cycles (Induction).
Temozolomide
Participants received Temozolomide (150 mg/ m2) treatment, every 4 weeks for up to 6 cycles (Induction).
Interventions
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Vebreltinib + Temozolomide
Vebreltinib is a capsule in the form of 25 mg and 100mg, twice daily. Participants received Vebreltinib (300 mg Bid) in combination with Temozolomide (150 mg/ m2) treatment, every 4 weeks for up to 6 cycles (Induction).
Temozolomide
Participants received Temozolomide (150 mg/ m2) treatment, every 4 weeks for up to 6 cycles (Induction).
Eligibility Criteria
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Inclusion Criteria
2. Newly diagnosed GBM (WHO grade 4) patients with maximal surgical resection
3. c-MET overexpression diagnosed by IHC
4. KPS ≥60
5. Adequate hematological, renal, and hepatic function.
All patients should meet the following criteria:
1. absolute neutrophil count (ANC) ≥1.5 × 109/L and platelet count≥100 × 109/L
2. serum creatinine clearance ≥80 mL/min
3. total bilirubin level ≤ 1.5 × ULN (except patients with Gilbert syndrome)
4. aspartate aminotransferase (AST) ≤ 3.0 × ULN, alanine aminotransferase (ALT) ≤ 3.0 × ULN, and AST/ALT \< 2.5 × ULN
6. The patient and his/her family members were informed and provided signed and informed consent
Exclusion Criteria
2. Individuals unable to undergo cranial MRI examination;
3. Active hemorrhage detected by cranial CT or MRI scan before enrollment;
4. Uncontrolled hypertension;
5. Decompensated heart failure, unstable angina pectoris, acute myocardial infarction, or persistent and clinically significant arrhythmias within 3 months before enrollment;
6. Anti-HIV (+), or both anti-HCV and HCV-RNA (+), or HBsAg positive with HBV-DNA \>1000IU/ml;
7. Individuals requiring long-term continuous use of hematopoietic growth factors or platelet transfusions;
8. Pregnant or lactating women;
9. Individuals who have received other clinical trial drugs within 30 days before the first dose of the study drug;
10. Individuals deemed unsuitable for participation in this clinical trial by the investigator.
18 Years
65 Years
ALL
No
Sponsors
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Beijing Tiantan Hospital
OTHER
Beijing Sanbo Brain Hospital
OTHER
Huashan Hospital
OTHER
Responsible Party
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Jinsong Wu
Professor
Central Contacts
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Other Identifiers
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KY2024-754
Identifier Type: -
Identifier Source: org_study_id
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