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Not yet recruiting NCT06780592

Vebreltinib Combined With Temozolomide for Glioblastoma (GBM) After Surgery

Phase II Interventional Glioblastoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Vebreltinib + Temozolomide, Temozolomide.
Who it may be relevant to
Registry conditions: Glioblastoma. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug 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).
  • Drug Temozolomide
    Participants received Temozolomide (150 mg/ m2) treatment, every 4 weeks for up to 6 cycles (Induction).

Primary outcome measures

  • Progression-Free Survival (PFS) [Time frame: Every 4 weeks (±14 days) from enrollment until the last enrolled participant completes a 12-month follow-up or is lost to follow-up.]
Secondary outcome measures (4)
  • Overall survival (OS) [Time frame: Every 4 weeks (±14 days) from enrollment until the last enrolled participant completes a 12-month follow-up or is lost to follow-up.]
  • The Karnof sky Performance status scale (KPS) [Time frame: Every 4 weeks (±14 days) from enrollment until the last enrolled participant completes a 12-month follow-up or is lost to follow-up.]
  • Objective response rate (ORR) [Time frame: Every 4 weeks (±14 days) from enrollment until the last enrolled participant completes a 12-month follow-up or is lost to follow-up.]
  • Incidence of adverse events (AEs) [Time frame: Every 4 weeks (±14 days) from enrollment until the last enrolled participant completes a 12-month follow-up or is lost to follow-up.]

Eligibility criteria

Inclusion criteria

  • Aged 18-65 years, female or male
  • Newly diagnosed GBM (WHO grade 4) patients with maximal surgical resection
  • c-MET overexpression diagnosed by IHC
  • KPS ≥60
  • Adequate hematological, renal, and hepatic function.

All patients should meet the following criteria:

  • absolute neutrophil count (ANC) ≥1.5 × 109/L and platelet count≥100 × 109/L
  • serum creatinine clearance ≥80 mL/min
  • total bilirubin level ≤ 1.5 × ULN (except patients with Gilbert syndrome)
  • aspartate aminotransferase (AST) ≤ 3.0 × ULN, alanine aminotransferase (ALT) ≤ 3.0 × ULN, and AST/ALT < 2.5 × ULN
  • The patient and his/her family members were informed and provided signed and informed consent

Exclusion criteria

  • Any previous postoperative treatment except for concurrent chemoradiotherapy;
  • Individuals unable to undergo cranial MRI examination;
  • Active hemorrhage detected by cranial CT or MRI scan before enrollment;
  • Uncontrolled hypertension;
  • Decompensated heart failure, unstable angina pectoris, acute myocardial infarction, or persistent and clinically significant arrhythmias within 3 months before enrollment;
  • Anti-HIV (+), or both anti-HCV and HCV-RNA (+), or HBsAg positive with HBV-DNA >1000IU/ml;
  • Individuals requiring long-term continuous use of hematopoietic growth factors or platelet transfusions;
  • Pregnant or lactating women;
  • Individuals who have received other clinical trial drugs within 30 days before the first dose of the study drug;
  • Individuals deemed unsuitable for participation in this clinical trial by the investigator.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06780592 · KY2024-754

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗