Vebreltinib Combined With Temozolomide for Glioblastoma (GBM) After Surgery

Phase 2

Not yet recruiting

• Conditions: Glioblastoma
• Interventions: Drug: Vebreltinib + Temozolomide; Drug: Temozolomide

• Registration Number: NCT06780592
• Lead Sponsor: Huashan Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study Start: 2025-01-13
• Study First Submitted: 2025-01-13
• Study First Submitted QC: 2025-01-13
• Study First Posted: 2025-01-17
• Last Update Submitted: 2025-01-20
• Last Update Posted: 2025-01-22
• Primary Completion: 2025-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)