Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2026-01-04 @ 10:47 AM
Study NCT ID:
NCT03243851
Status:
COMPLETED
Last Update Posted:
2021-09-09
First Post:
2017-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on Low Dose Temozolomide Plus Metformin or Placebo in Patient With Recurrent or Refractory Glioblastoma
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double blinded'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Arm 1 : Low dose temozolomide+metformin Arm 2 : Low dose temozolomide+placebo'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-08', 'studyFirstSubmitDate': '2017-07-29', 'studyFirstSubmitQcDate': '2017-08-04', 'lastUpdatePostDateStruct': {'date': '2021-09-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of progression-free survival obtained from progression-free survival curve', 'timeFrame': '24 weeks', 'description': 'Comparison of progression-free survival obtained from progression-free survival curve'}], 'secondaryOutcomes': [{'measure': 'Response Rate', 'timeFrame': '4 weeks, 8 weeks, 16 weeks, 24 weeks thereafter every 24 weeks up to 96 weeks', 'description': 'Tumor Response Rate'}, {'measure': 'Tumor control probability', 'timeFrame': '4 weeks, 8 weeks, 16 weeks, 24 weeks thereafter every 24 weeks up to 96 weeks', 'description': 'Tumor control probability'}, {'measure': '6 month progression free survival', 'timeFrame': '24 weeks', 'description': '6 month progression free survival'}, {'measure': '6 month overall survival', 'timeFrame': '24 weeks', 'description': '6 month overall survival'}, {'measure': 'Assessment of the quality of life of cancer patients', 'timeFrame': '4 weeks, 8 weeks, 16 weeks, 24 weeks', 'description': 'EORTC QLQ-C30 and EORTC QLQ-BN20'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Glioblastoma'], 'conditions': ['Glioblastoma']}, 'referencesModule': {'references': [{'pmid': '37278858', 'type': 'DERIVED', 'citation': 'Yoon WS, Chang JH, Kim JH, Kim YJ, Jung TY, Yoo H, Kim SH, Ko YC, Nam DH, Kim TM, Kim SH, Park SH, Lee YS, Yim HW, Hong YK, Yang SH. Efficacy and safety of metformin plus low-dose temozolomide in patients with recurrent or refractory glioblastoma: a randomized, prospective, multicenter, double-blind, controlled, phase 2 trial (KNOG-1501 study). Discov Oncol. 2023 Jun 6;14(1):90. doi: 10.1007/s12672-023-00678-3.'}]}, 'descriptionModule': {'briefSummary': 'A phase 2 clinical trial for the efficacy and safety of low dose Temozolomide plus metformin as combination chemotherapy compared with low dose Temozolomide plus placebo in patient with recurrent or refractory Glioblastoma', 'detailedDescription': 'Studies will investigate the efficacy and safety of low dose Temozolomide with Metformin or placebo for the patients with recurrent or refractory Glioblastoma.\n\nThe dosage of the Metformin will follow the domestically permitted dose to minimize side effects.\n\nThe patients will be allocated randomly to arm 1(experimental) and arm 2(placebo controlled) and administered the investigational products for up to 6 cycle. Each cycle consists of 4 weeks.\n\nAfter 6 cycle(24 weeks), the patients will be checked progression and survival every 24 weeks up to 96 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Progressive or recurrent Glioblastoma conformed by histopathological or radiological diagnosis. Progressive or recurrent Glioblastoma during or after standard therapy (Temozolomide after Temozolomide and radiation therapy; Stupp regimen) after histopathological diagnosis of Glioblastoma Recurrence or progression is diagnosed according to histopathological diagnosis or revised RANO(Response Assessment in Neuro-Oncology) criteria c\n2. Karnofsky performance status(KPS) ≥ 60%\n3. Age ≥ 19 years old\n4. At least 4 weeks after operation or chemotherapy\n5. Normal in hematological finding, liver and kidney function\n\n * Hematology ANC \\> 1.500/mm³, Platelet \\> 100,000/mm³, WBC \\> 3×10\\^9/L, Hemoglobin \\> 9g/dL\n * Liver function Total Bilirubin level ≤ 1.5×ULN(in case of isolated hyperbilirubinemia ≤2.5 x ULN) AST / ALT \\< 2.5×ULN\n * Renal function Serum creatinine ≤ 1.5mg/dL\n6. Be informed of the nature of the study and obtained a written informed consent\n7. A legal representative agrees to the trial when a subject is unable to communicate smoothly due to neurologic defect\n8. If a fertile woman who has been confirmed negative to a urine or blood pregnancy test within 28 days prior to the trial\n\nExclusion Criteria:\n\n1. Pregnant or breast feeding\n2. Cancer history within 5 years excluding cancer in the skin cells and cervix\n3. Active infections within two weeks\n4. Leptomeningeal metastasis\n5. Patients diagnosed with diabetes\n6. Hypersensitive or intolerance to Metformin\n7. Patients who are currently taking Metformin, sulfonylureas, thiazolidinediones, and insulin, regardless of reason\n8. Other serious diseases or medical conditions that include :\n\n * Patients who suffer from unstable heart disease despite treatment.\n * Patients having a heart attack within 6 months prior to the start of trial\n * Patients who suffer from severe nerve or psychosis that includes dementia or strokes.\n * Patients with an uncontrolled infection\n * Patient with uncontrolled hypertension, congestive heart failure, unstable angina, or incomplete arrhythmia\n9. Those who have participated in other clinical trials may not recover from the toxicity of the treatment.'}, 'identificationModule': {'nctId': 'NCT03243851', 'acronym': 'METT', 'briefTitle': 'Study on Low Dose Temozolomide Plus Metformin or Placebo in Patient With Recurrent or Refractory Glioblastoma', 'organization': {'class': 'OTHER', 'fullName': "Seoul St. Mary's Hospital"}, 'officialTitle': 'Efficacy and Safety of Low Dose Temozolomide Plus Metformin as Combination Chemotherapy Compared With Low Dose Temozolomide Plus Placebo in Patient With Recurrent or Refractory Glioblastoma', 'orgStudyIdInfo': {'id': 'KNOG-1501'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Temozolomide+metformin', 'description': 'Temozolomide :\n\n1 cycle of 4 weeks with daily dose 50mg/m2(BSA: Body Surface Area) up to 6 cycles for 24 weeks\n\nMetformin :\n\n1. 1st cycle (4 weeks)\n\n * 1 week(1st\\~7th day) = 1,000mg/day\n * 1 week(8th\\~14th day) = 1,500mg/day\n * 2 weeks(15th \\~28th day) = 2,000mg/day\n2. 2nd to 6th cycle (20 weeks) = 2,000mg/day', 'interventionNames': ['Drug: Temozolomide+Metformin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Temozolomide+placebo', 'description': 'Temozolomide :\n\n1 cycle of 4 weeks with daily dose 50mg/m2(BSA: Body Surface Area) up to 6 cycles for 24 weeks\n\nPlacebo:\n\n1. 1st cycle (4 weeks)\n\n * 1 week(1st\\~7th day) = 1,000mg/day\n * 1 week(8th\\~14th day) = 1,500mg/day\n * 2 weeks(15th\\~28th day) = 2,000mg/day\n2. 2nd to 6th cycle (20 weeks) = 2,000mg/day', 'interventionNames': ['Drug: Temozolomide+Placebo']}], 'interventions': [{'name': 'Temozolomide+Metformin', 'type': 'DRUG', 'description': 'Low dose temozolomide+metformin for 24 weeks', 'armGroupLabels': ['Temozolomide+metformin']}, {'name': 'Temozolomide+Placebo', 'type': 'DRUG', 'description': 'Low dose temozolomide+placebo for 24 weeks', 'armGroupLabels': ['Temozolomide+placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10408', 'city': 'Ilsan', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'National Cancer Center Korea'}, {'zip': '13620', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}, {'zip': '16499', 'city': 'Suwon', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Ajou University Hospital', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}, {'zip': '58128', 'city': 'Hwasun', 'state': 'Jeollanam-do', 'country': 'South Korea', 'facility': 'Chonnam National University Hwasun Hospital', 'geoPoint': {'lat': 35.06125, 'lon': 126.98746}}, {'zip': '21431', 'city': 'Incheon', 'country': 'South Korea', 'facility': "Incheon St. Mary's Hospital", 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03722', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '05030', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Konkuk University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '05505', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06351', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06591', 'city': 'Seoul', 'country': 'South Korea', 'facility': "Seoul St Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '16247', 'city': 'Suwon', 'country': 'South Korea', 'facility': "Saint Vincent's Hospital, Korea", 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}], 'overallOfficials': [{'name': 'Yong-Kil Hong, MD.,PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Seoul St. Mary's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yong-Kil Hong', 'class': 'OTHER'}, 'collaborators': [{'name': "Saint Vincent's Hospital, Korea", 'class': 'OTHER'}, {'name': "Incheon St.Mary's Hospital", 'class': 'OTHER'}, {'name': 'National Cancer Center, Korea', 'class': 'OTHER_GOV'}, {'name': 'Konkuk University Hospital', 'class': 'OTHER'}, {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, {'name': 'Samsung Medical Center', 'class': 'OTHER'}, {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, {'name': 'Asan Medical Center', 'class': 'OTHER'}, {'name': 'Ajou University School of Medicine', 'class': 'OTHER'}, {'name': 'Severance Hospital', 'class': 'OTHER'}, {'name': 'Chonnam National University Hospital', 'class': 'OTHER'}, {'name': "Seoul St. Mary's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD., PhD.', 'investigatorFullName': 'Yong-Kil Hong', 'investigatorAffiliation': "Seoul St. Mary's Hospital"}}}}