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Vebreltinib Combined With Temozolomide for Glioblastoma (GBM) After Surgery | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE2

Vebreltinib Combined With Temozolomide for Glioblastoma (GBM) After Surgery

The Efficacy of Vebreltinib Combined With Temozolomide for Glioblastoma (GBM) After Surgery: a Study Protocol for a Prospective, Open-label ,Multi-center, Randomized, Controlled Trial in China

NCT06780592•Huashan Hospital

View on ClinicalTrials.gov

Summary

The purpose of this study is to explore the effects of Vebreltinib in primary glioblastoma patients receiving a combination therapy of chemotherapy (temozolomidel) and MET-TKI.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Aged 18-65 years, female or male
•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
+1 more criteria

Exclusion Criteria

•1. Any previous postoperative treatment except for concurrent chemoradiotherapy;
•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.

Key Dates

Start Date

January 13, 2025

Primary Completion Date

December 31, 2025

Completion Date

December 31, 2027

Last Updated

January 22, 2025

Enrollment

ESTIMATED participants

Conditions

Glioblastoma

Interventions

Vebreltinib + Temozolomide

DRUG

Temozolomide

DRUG

Contacts

Jinsong Wu, Professor

CONTACT

+86-13701707118 wjsongc@126.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 22, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Vebreltinib Combined With Temozolomide for Glioblastoma (GBM) After Surgery

Inclusion Criteria

Exclusion Criteria

Targeted Pediatric High-Grade Glioma Therapy

Testing the Addition of an Anti-Cancer Drug, Triapine, to the Usual Radiation Therapy for Recurrent Glioblastoma or Astrocytoma

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