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NCT Number: NCT06780592

Vebreltinib Combined With Temozolomide for Glioblastoma (GBM) After Surgery

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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).

Temozolomide

Drug

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

Primary outcomes

  1. Progression-Free Survival (PFS)

    Time frame: 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 outcomes

  1. Overall survival (OS)

    Time frame: 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

  2. The Karnof sky Performance status scale (KPS)

    Time frame: 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).

  3. Objective response rate (ORR)

    Time frame: 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)

  4. Incidence of adverse events (AEs)

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Jinsong Wu, Professor

CONTACT

[email protected]

+86-13701707118

Sponsors and collaborators

Lead sponsor

Huashan Hospital

Other

Collaborators

  • Beijing Sanbo Brain Hospital
  • Beijing Tiantan Hospital

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2027
First posted
Jan 17, 2025
Registry last updated
Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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