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Vebreltinib Combined With Temozolomide for Glioblastoma (GBM) After Surgery

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 65 Years
Gender	All

More Inclusion & Exclusion Criteria

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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06780592
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Huashan Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioblastoma

Arms & Interventions

Arms

Experimental: 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).

Active Comparator: Temozolomide

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

Interventions

Drug: - Vebreltinib + 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).

Drug: - Temozolomide

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

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Jinsong Wu, Professor

[email protected]

+86-13701707118

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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