Clinical trial NCT06780592: Vebreltinib Combined With Temozolomide for Glioblastoma (GBM) After Surgery
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Glioblastoma
Keywords: Vebreltinib
Temozolomide
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Tiantan Hospital
name: Beijing Sanbo Brain Hospital
First posted: 2025-01-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective, multi-center, randomized, open-label, clinical trial in China.

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.
Primary purpose: TREATMENT

Brief 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 criteria: 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
6. The patient and his/her family members were informed and provided signed and informed consent

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.

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: 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 outcomes:
measure: Overall survival (OS)
timeFrame: Every 4 weeks (±14 days) from enrollment until the last enrolled participant completes a 12-month follow-up or is lost to follow-up.
measure: The Karnof sky Performance status scale (KPS)
timeFrame: Every 4 weeks (±14 days) from enrollment until the last enrolled participant completes a 12-month follow-up or is lost to follow-up.
measure: Objective response rate (ORR)
timeFrame: Every 4 weeks (±14 days) from enrollment until the last enrolled participant completes a 12-month follow-up or is lost to follow-up.
measure: Incidence of adverse events (AEs)
timeFrame: Every 4 weeks (±14 days) from enrollment until the last enrolled participant completes a 12-month follow-up or is lost to follow-up.
Other outcomes:
Locations:
Study officials:
References: