Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-02-23 @ 12:22 PM
Study NCT ID:
NCT03618667
Status:
COMPLETED
Last Update Posted:
2023-05-12
First Post:
2018-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GC1118 in Recurrent Glioblastoma Patients With High EGFR Amplification
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': 'C000611922', 'term': 'GC1118'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-04-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-11', 'studyFirstSubmitDate': '2018-07-07', 'studyFirstSubmitQcDate': '2018-08-05', 'lastUpdatePostDateStruct': {'date': '2023-05-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': 'at 6 months', 'description': 'survival time from screening to progression defined by RANO criteria'}], 'secondaryOutcomes': [{'measure': 'overall survival', 'timeFrame': '6 months, 12 month', 'description': 'survival time from screening to death of any cause'}, {'measure': 'overall response rate', 'timeFrame': 'up to 30months', 'description': 'best overall response rate defined by RANO criteria'}, {'measure': 'Exploration of predictive/prognostic biomarkers', 'timeFrame': 'up to 30 months', 'description': 'according to NGS-based biomarkers(whole exome sequencing and whole transcriptome sequencing)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Glioblastoma, Adult', 'EGFR Amplification']}, 'descriptionModule': {'briefSummary': 'This study is a phase 2 trial of GC1118, an EGFR monoclonal antibody, for recurrent glioblastoma patients who were treated with standard concurrent chemoradiation.', 'detailedDescription': 'This study is a phase 2 trial of GC1118, an EGFR monoclonal antibody, for recurrent glioblastoma patients who were treated with standard concurrent chemoradiation.\n\nGC1118 (4mg/kg) will be administered by IV infusion once per week for 4 weeks(28-day cycle) up to 6 cycles.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. written informed consent\n2. 19 years or older\n3. patients who experience recurrence following the standard therapy (CCRT, adjuvant temozolomide)\n4. high EGFR amplification\n5. available archive tumor sample(s)\n6. Karnofsky performance status (KPS) \\> 70\n7. life expectancy \\> 3 months\n8. adequate end-organ function\n9. patients who recovered from previous therapy (NCI CTCAE v4.03 Gr 1)\n\nExclusion Criteria:\n\n1. patients who had EGFR target agent(s) before screening\n2. patients who have clinically significant cardiopulmonary dysfunction (cardiovascular disease (\\> 2grade, NYHA), myocardial infarction within previous 3 months, unstable angina, unstable arrythmia, clinically significant interstitial lung disease)\n3. patients who had major surgery, open biopsy, or clinically significant trauma within previous 4 weeks\n4. patients who had investigation drug(s) within previous 4 weeks\n5. patients who had other malignancy(ies) within previous 3 years (except malignancies with low tendency to metastases or mortality for example, treated cervical intraepithelial neoplasia, skin cancer except melanoma, localized prostate cancer)\n6. patients who had severe infection within previous 4 weeks\n7. HIV infection\n8. patients who had anti-cancer therapy (surgery, chemo-radiation, chemotherapy, radiation therapy) within previous 4 weeks\n9. clinically significant liver disease (active hepatitis B viral (HBV) or hepatitis C viral (HCV) infection, alcoholic liver disease etc)\n10. pregnancy or breast-feeding'}, 'identificationModule': {'nctId': 'NCT03618667', 'briefTitle': 'GC1118 in Recurrent Glioblastoma Patients With High EGFR Amplification', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'A Phase II Clinical Study of GC1118 in Recurrent Glioblastoma Patients With High Epidermal Growth Factor Receptor (EGFR) Amplification', 'orgStudyIdInfo': {'id': 'SMC2017-06-111'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'single group', 'description': 'GC1118 (4mg/kg) will be administered by IV infusion once per week for 4 weeks(28-day cycle) up to 6 cycles, or till progression or uncontrolled toxicity.', 'interventionNames': ['Drug: GC1118']}], 'interventions': [{'name': 'GC1118', 'type': 'DRUG', 'description': 'GC1118 (4mg/kg) will be administered by IV infusion once per week for 4 weeks(28-day cycles) up to 6 cycles, or till progression or uncontrolled toxicity.', 'armGroupLabels': ['single group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '135710', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'sehoon lee, professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Samsung Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Se-Hoon Lee', 'investigatorAffiliation': 'Samsung Medical Center'}}}}