Ignite Creation Date:
2025-12-24 @ 3:36 PM
Ignite Modification Date:
2025-12-24 @ 3:36 PM
Study NCT ID:
NCT06780592
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-22
First Post:
2025-01-13
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Vebreltinib Combined With Temozolomide for Glioblastoma (GBM) After Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005909', 'term': 'Glioblastoma'}], 'ancestors': [{'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D005910', 'term': 'Glioma'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077204', 'term': 'Temozolomide'}], 'ancestors': [{'id': 'D003606', 'term': 'Dacarbazine'}, {'id': 'D014226', 'term': 'Triazenes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a prospective, multi-center, randomized, open-label, clinical trial in China.\n\nThe 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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01-13', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-20', 'studyFirstSubmitDate': '2025-01-13', 'studyFirstSubmitQcDate': '2025-01-13', 'lastUpdatePostDateStruct': {'date': '2025-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'Every 4 weeks (±14 days) from enrollment until the last enrolled participant completes a 12-month follow-up or is lost to follow-up.', 'description': 'The primary outcome is the PFS of patients, the time from randomization and group allocation to any recorded disease progression, and even death.'}], 'secondaryOutcomes': [{'measure': 'Overall survival (OS)', 'timeFrame': 'Every 4 weeks (±14 days) from enrollment until the last enrolled participant completes a 12-month follow-up or is lost to follow-up.', 'description': 'The time from randomization and allocation to death for any reason'}, {'measure': 'The Karnof sky Performance status scale (KPS)', 'timeFrame': 'Every 4 weeks (±14 days) from enrollment until the last enrolled participant completes a 12-month follow-up or is lost to follow-up.', 'description': 'The scale measures the levels of patient activity and medical needs. The score ranges from 100 (no signs of disease) to 0 (dead).'}, {'measure': 'Objective response rate (ORR)', 'timeFrame': 'Every 4 weeks (±14 days) from enrollment until the last enrolled participant completes a 12-month follow-up or is lost to follow-up.', 'description': '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)'}, {'measure': 'Incidence of adverse events (AEs)', 'timeFrame': 'Every 4 weeks (±14 days) from enrollment until the last enrolled participant completes a 12-month follow-up or is lost to follow-up.', 'description': 'Adverse events (CTC-Toxicity ≥ grade III) will be recorded and analyzed based on the Common Terminology Criteria for Adverse Events (CTC-AE)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vebreltinib', 'Temozolomide'], 'conditions': ['Glioblastoma']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged 18-65 years, female or male\n2. Newly diagnosed GBM (WHO grade 4) patients with maximal surgical resection\n3. c-MET overexpression diagnosed by IHC\n4. KPS ≥60\n5. Adequate hematological, renal, and hepatic function.\n\n All patients should meet the following criteria:\n 1. absolute neutrophil count (ANC) ≥1.5 × 109/L and platelet count≥100 × 109/L\n 2. serum creatinine clearance ≥80 mL/min\n 3. total bilirubin level ≤ 1.5 × ULN (except patients with Gilbert syndrome)\n 4. aspartate aminotransferase (AST) ≤ 3.0 × ULN, alanine aminotransferase (ALT) ≤ 3.0 × ULN, and AST/ALT \\< 2.5 × ULN\n6. The patient and his/her family members were informed and provided signed and informed consent\n\nExclusion Criteria:\n\n1. Any previous postoperative treatment except for concurrent chemoradiotherapy;\n2. Individuals unable to undergo cranial MRI examination;\n3. Active hemorrhage detected by cranial CT or MRI scan before enrollment;\n4. Uncontrolled hypertension;\n5. Decompensated heart failure, unstable angina pectoris, acute myocardial infarction, or persistent and clinically significant arrhythmias within 3 months before enrollment;\n6. Anti-HIV (+), or both anti-HCV and HCV-RNA (+), or HBsAg positive with HBV-DNA \\>1000IU/ml;\n7. Individuals requiring long-term continuous use of hematopoietic growth factors or platelet transfusions;\n8. Pregnant or lactating women;\n9. Individuals who have received other clinical trial drugs within 30 days before the first dose of the study drug;\n10. Individuals deemed unsuitable for participation in this clinical trial by the investigator.'}, 'identificationModule': {'nctId': 'NCT06780592', 'briefTitle': 'Vebreltinib Combined With Temozolomide for Glioblastoma (GBM) After Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Huashan Hospital'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'KY2024-754'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vebreltinib + Temozolomide', 'description': 'Participants received Vebreltinib (300 mg Bid) in combination with Temozolomide (150 mg/m2) treatment, every 4 weeks for up to 6 cycles (Induction).', 'interventionNames': ['Drug: Vebreltinib + Temozolomide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Temozolomide', 'description': 'Participants received Temozolomide (150 mg/m2) treatment, every 4 weeks for up to 6 cycles (Induction).', 'interventionNames': ['Drug: Temozolomide']}], 'interventions': [{'name': 'Vebreltinib + Temozolomide', 'type': 'DRUG', 'description': '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).', 'armGroupLabels': ['Vebreltinib + Temozolomide']}, {'name': 'Temozolomide', 'type': 'DRUG', 'description': 'Participants received Temozolomide (150 mg/ m2) treatment, every 4 weeks for up to 6 cycles (Induction).', 'armGroupLabels': ['Temozolomide']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jinsong Wu, Professor', 'role': 'CONTACT', 'email': 'wjsongc@126.com', 'phone': '+86-13701707118'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Huashan Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beijing Tiantan Hospital', 'class': 'OTHER'}, {'name': 'Beijing Sanbo Brain Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jinsong Wu', 'investigatorAffiliation': 'Huashan Hospital'}}}}