Vebreltinib Combined With Temozolomide for Glioblastoma (GBM) After Surgery

Fudan University

Status and phase: Not yet enrolling; Phase 2

Conditions: Glioblastoma

Treatments: Drug: Vebreltinib + Temozolomide; Drug: Temozolomide

Study type: Interventional

Funder types: Other

Identifiers

NCT06780592

KY2024-754

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Vebreltinib + Temozolomide

Experimental group

Description:

Participants received Vebreltinib (300 mg Bid) in combination with Temozolomide (150 mg/m2) treatment, every 4 weeks for up to 6 cycles (Induction).

Treatment:

Drug: Vebreltinib + Temozolomide

Temozolomide

Active Comparator group

Description:

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

Treatment:

Drug: Temozolomide