Glioblastoma
Conditions
Keywords
Vebreltinib, Temozolomide
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.
Interventions
DRUGVebreltinib + 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).
DRUGTemozolomide
Participants received Temozolomide (150 mg/ m2) treatment, every 4 weeks for up to 6 cycles (Induction).
Sponsors
Beijing Tiantan Hospital
Beijing Sanbo Brain Hospital
Huashan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) | 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 primary outcome is the PFS of patients, the time from randomization and group allocation to any recorded disease progression, and even death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | 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 time from randomization and allocation to death for any reason |
| The Karnof sky Performance status scale (KPS) | 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 scale measures the levels of patient activity and medical needs. The score ranges from 100 (no signs of disease) to 0 (dead). |
| Objective response rate (ORR) | 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) = (CR + PR)/total number of cases × 100%. A complete response (CR) is defined as the disappearance of all target lesions. A partial response (PR) is defined as a reduction of at least 30% in the sum of diameters of the target lesions, considering the baseline sum diameters as a reference. The ORR will be determined by MRI according to the Response Evaluation Citeria in Solid Tumors (RECIST) |
| Incidence of adverse events (AEs) | Every 4 weeks (±14 days) from enrollment until the last enrolled participant completes a 12-month follow-up or is lost to follow-up. | Adverse events (CTC-Toxicity ≥ grade III) will be recorded and analyzed based on the Common Terminology Criteria for Adverse Events (CTC-AE) |
Contacts
Primary ContactJinsong Wu, Professor
Outcome results
None listed