GlioblastomaPhase 2NCT06780592
Vebreltinib Combined With Temozolomide for Glioblastoma (GBM) After Surgery
A Phase 2 study testing Vebreltinib + Temozolomide and Temozolomide in people with Glioblastoma, run by Huashan Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Vebreltinib + Temozolomide and Temozolomide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 13 Jan 2025to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 11Show fewer
- 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
Who cannot join
- 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;
Show all 10Show fewer
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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
- Being tested
- Vebreltinib + Temozolomide, Temozolomide
- Keywords
- Vebreltinib, Temozolomide
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vebreltinib + TemozolomideDrug
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).
TemozolomideDrug
Participants received Temozolomide (150 mg/ m2) treatment, every 4 weeks for up to 6 cycles (Induction).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Vebreltinib + Temozolomide |
| Temozolomide | Active comparator | Participants received Temozolomide (150 mg/m2) treatment, every 4 weeks for up to 6 cycles (Induction). Receives: Drug: Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
The time from randomization and allocation to death for any reason
Measured: 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)
The scale measures the levels of patient activity and medical needs. The score ranges from 100 (no signs of disease) to 0 (dead).
Measured: 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)
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)
Measured: 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)
Adverse events (CTC-Toxicity ≥ grade III) will be recorded and analyzed based on the Common Terminology Criteria for Adverse Events (CTC-AE)
Measured: Every 4 weeks (±14 days) from enrollment until the last enrolled participant completes a 12-month follow-up or is lost to follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start13 Jan 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tiantan Hospital, Beijing Sanbo Brain Hospital
- Responsible party
- Principal investigator, Jinsong Wu, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06780592
- Sponsor's protocol ID
- KY2024-754
- Status last verified
- Jan 2025
- First submitted
- 13 Jan 2025
- Last updated
- 22 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06780592
- Acronym / sponsor ID
- KY2024-754
- Conditions
- Glioblastoma
- Keywords
- Vebreltinib, Temozolomide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Collaborators
- Beijing Tiantan Hospital, Beijing Sanbo Brain Hospital
- Study start
- 13 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Vebreltinib + Temozolomide | Experimental | Drug: Vebreltinib + TemozolomideParticipants received Vebreltinib (300 mg Bid) in combination with Temozolomide (150 mg/m2) treatment, every 4 weeks for up to 6 cycles (Induction). |
| Temozolomide | Active comparator | Drug: TemozolomideParticipants received Temozolomide (150 mg/m2) treatment, every 4 weeks for up to 6 cycles (Induction). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vebreltinib + TemozolomideVebreltinib 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 | Vebreltinib + Temozolomide |
| TemozolomideParticipants received Temozolomide (150 mg/ m2) treatment, every 4 weeks for up to 6 cycles (Induction). | Drug | Temozolomide |
Primary outcome
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.
4 secondary outcomes
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 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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Glioblastoma
Active, not recruitingPhase 3
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
Glioblastoma
RecruitingPhase 3
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Glioblastoma
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma
Active, not recruitingPhase 1
Oral Gallium Maltolate for the Treatment of Relapsed and Refractory Glioblastoma
Glioblastoma
RecruitingPhase 1/2
PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications
Glioma, Medulloblastoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vebreltinib + Temozolomide and Temozolomide in people with Glioblastoma, run by Huashan Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jinsong Wu, Professor (+86-13701707118, wjsongc@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.