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NCT06780592Not yet recruitingPhase 2

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

Source: ClinicalTrials.gov · Last updated 22 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
60 (estimated)
First submitted
13 Jan 2025
Start date
13 Jan 2025
Primary completion date
31 Dec 2025
Lead sponsor
Huashan Hospital
Diseases
Glioblastoma
NCT number
NCT06780592

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 60
  • From 13 Jan 2025 to the primary completion date, 31 Dec 2025
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Any previous postoperative treatment except for concurrent chemoradiotherapy;
  • Decompensated heart failure, unstable angina pectoris, acute myocardial infarction, or persistent and clinically significant arrhythmias within 3 months before enrollment;
  • Individuals who have received other clinical trial drugs within 30 days before the first dose of the study drug;

Other illness

  • Active hemorrhage detected by cranial CT or MRI scan before enrollment;
  • Uncontrolled hypertension;
  • Anti-HIV (+), or both anti-HCV and HCV-RNA (+), or HBsAg positive with HBV-DNA \>1000IU/ml;

Lab values

  • Individuals requiring long-term continuous use of hematopoietic growth factors or platelet transfusions;

Other

  • Individuals unable to undergo cranial MRI examination;
  • Pregnant or lactating women;
  • Individuals deemed unsuitable for participation in this clinical trial by the investigator.

Who the study is looking for

  • 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

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.