Vebreltinib Combined With Temozolomide for Glioblastoma (GBM) After Surgery

NCT06780592 | Not Yet Recruiting Phase 2

• 1 other identifier: KY2024-754
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Glioblastoma

Keywords

Vebreltinib; Temozolomide

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  The primary outcome is the PFS of patients, the time from randomization and group allocation to any recorded disease progression, and even death.

  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 (4)

• 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 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.

• 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.

• 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.

Study Arms (2)

Vebreltinib + Temozolomide

EXPERIMENTAL

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

Drug: Vebreltinib + Temozolomide

Temozolomide

ACTIVE COMPARATOR

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

Drug: Temozolomide

Interventions

Vebreltinib + Temozolomide DRUG

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).

Vebreltinib + Temozolomide

Temozolomide DRUG

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

Temozolomide

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Any previous postoperative treatment except for concurrent chemoradiotherapy;
• Individuals unable to undergo cranial MRI examination;
• Active hemorrhage detected by cranial CT or MRI scan before enrollment;
• Uncontrolled hypertension;
• Decompensated heart failure, unstable angina pectoris, acute myocardial infarction, or persistent and clinically significant arrhythmias within 3 months before enrollment;
• Anti-HIV (+), or both anti-HCV and HCV-RNA (+), or HBsAg positive with HBV-DNA \>1000IU/ml;
• Individuals requiring long-term continuous use of hematopoietic growth factors or platelet transfusions;
• Pregnant or lactating women;
• Individuals who have received other clinical trial drugs within 30 days before the first dose of the study drug;
• Individuals deemed unsuitable for participation in this clinical trial by the investigator.

Sponsors & Collaborators

• Huashan Hospital: lead
• Beijing Tiantan Hospital: collaborator
• Beijing Sanbo Brain Hospital: collaborator

MeSH Terms

Conditions

Glioblastoma

Interventions

Temozolomide

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Jinsong Wu, Professor

CONTACT

+86-13701707118; wjsongc@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 17, 2025
• Study Start: January 13, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share