Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2026-01-21 @ 7:18 PM
Study NCT ID:
NCT02691793
Status:
COMPLETED
Last Update Posted:
2022-06-15
First Post:
2016-02-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Safety and Efficacy of Sunitinib, in Subject With Refractory Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077210', 'term': 'Sunitinib'}], 'ancestors': [{'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2019-11-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-13', 'studyFirstSubmitDate': '2016-02-22', 'studyFirstSubmitQcDate': '2016-02-22', 'lastUpdatePostDateStruct': {'date': '2022-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'progression-free survival', 'timeFrame': '24 months'}], 'secondaryOutcomes': [{'measure': 'overall response rate', 'timeFrame': '24 months'}, {'measure': 'Time to progression', 'timeFrame': '24 months'}, {'measure': 'overall survival', 'timeFrame': '24 months'}, {'measure': 'Number of subjects with adverse events as a measure of safety', 'timeFrame': '24 months'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Refractory Solid Tumors']}, 'descriptionModule': {'briefSummary': 'This study is a single arm, pilot study of Sunitinib in patient with RET fusion positive, FGFR2 fusion/FGFR mutation Refractory solid tumor and/or specific sensitivity to Sunitinib by Avatar scan that has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy.\n\nTo investigate the efficacy and safety of Sunitinib in patient with Refractory solid tumor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provision of fully informed consent prior to study specific procedures.\n* Patients must be \\>= 19 years of age\n* RET fusion positive or FGFR2 fusion/other FGFR mutation Refractory solid tumor and/or specific sensitivity to Sunitinib by Avatar scan that has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy.\n* ECOG Performance status0-2\n* Have measurable or evaluated disease based on RECIST 1.1 as determined by investigator.\n* Adequate Organ Function Laboratory values\n\n * Absolute neutrophil count \\>= 1.5 x 109/L, Hemoglobin \\>= 9g/dL, Platelets\\>=100 x 109/L Bilirubin \\<= 1.5 x upper limit of normal AST/ALT \\<= 2.5 X upper limit of normal(5.0 x upper limit of normal, for subject with liver metastases) Creatinine\\<= 1.5 X UNL\n* Patients of child-bearing potential should be using adequate contraceptive measures should not be breast feeding and must have a negative pregnancy test prior to start of dosing\n* Adequate heart function\n\nExclusion Criteria:\n\n* Patients with second primary cancer, except:adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumor curatively treated with no evidence of disease for \\<= 5 years.\n* Has known active central nervous system(CNS) metastases\n* Has an active infection requiring systemic therapy\n* Pregnancy or breast feeding\n* Patients with cardiac problem\n* Any previous treatment with sunitinib'}, 'identificationModule': {'nctId': 'NCT02691793', 'briefTitle': 'Study to Evaluate the Safety and Efficacy of Sunitinib, in Subject With Refractory Solid Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Study to Evaluate the Safety and Efficacy of Sunitinib, in Subject With Refractory Solid Tumors', 'orgStudyIdInfo': {'id': '2016-02-098'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'sunitinib', 'description': 'sunitinib 50 mg will be administered orally daily', 'interventionNames': ['Drug: Sunitinib']}], 'interventions': [{'name': 'Sunitinib', 'type': 'DRUG', 'description': 'sunitinib 37.5mg QD', 'armGroupLabels': ['sunitinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '135-710', 'city': 'Seoul', 'state': 'Seoul, Korea, Republic of', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Seung tae Kim,PhMD', 'investigatorAffiliation': 'Samsung Medical Center'}}}}