Ignite Creation Date:
2025-12-24 @ 4:07 PM
Ignite Modification Date:
2025-12-24 @ 4:07 PM
Study NCT ID:
NCT04005066
Status:
COMPLETED
Last Update Posted:
2022-12-19
First Post:
2019-04-18
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase IV Study of Elunate® (Fruquintinib) in Chinese Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000591844', 'term': 'HMPL-013'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3005}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-09-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-15', 'studyFirstSubmitDate': '2019-04-18', 'studyFirstSubmitQcDate': '2019-07-01', 'lastUpdatePostDateStruct': {'date': '2022-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of AEs', 'timeFrame': 'from the first administration of fruquintinib up to 6 months', 'description': '% of patients with AEs according to CTCAE 4.03'}, {'measure': 'Incidence of ADRs', 'timeFrame': 'from the first administration of fruquintinib up to 6 months', 'description': '% of patients with ADRs according to CTCAE 4.03'}, {'measure': 'Incidence of SAEs', 'timeFrame': 'from the first administration of fruquintinib up to 6 months', 'description': '% of patients with SAEs according to CTC AE 4.03'}, {'measure': 'Incidence of AESI', 'timeFrame': 'from the first administration of fruquintinib up to 6 months', 'description': '% of patients with AESI according to CTC AE 4.03'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Patient Safety']}, 'descriptionModule': {'briefSummary': 'A phase IV study to characterize safety of Elunate® (Fruquintinib) in Chinese patients', 'detailedDescription': 'This study is a prospective, open-label, multi-center, study design to obtain the safety information of participant after medication. The follow-up time points for each participant include first time signing the informed consent form,1 month after signing the informed consent form, 6 months after signing the informed consent form or 30 days after the last dose (whichever occurs first).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Advanced solid tumor patients treated with Elunate®( fruquintinib) in Chinese real world practice', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Currently using Elunate®(Fruquintinib) or will use Elunate®(Fruquintinib) within a week;\n* Provision of informed consent by the patient.\n\nExclusion Criteria:\n\n• Unsuitable for the study according to investigator's judgement."}, 'identificationModule': {'nctId': 'NCT04005066', 'briefTitle': 'A Phase IV Study of Elunate® (Fruquintinib) in Chinese Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hutchmed'}, 'officialTitle': 'A Post-Marketing Clinical Study to Evaluate the Safety of Elunate® (Fruquintinib Capsules) in Chinese Patients.', 'orgStudyIdInfo': {'id': '2018-013-00CH2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1', 'description': '* Currently using Elunate® or will use Elunate®(Fruquintinib) within a week;\n* Provision of informed consent by the patient.', 'interventionNames': ['Drug: Elunate®']}], 'interventions': [{'name': 'Elunate®', 'type': 'DRUG', 'otherNames': ['Fruquintinib'], 'description': 'The recommended dose is 5 mg once daily (1 capsule, each capsule contains 5 mg of fruquintinib); three weeks of continuous drug administration followed by one week of drug free period (4 weeks as one treatment cycle).', 'armGroupLabels': ['Cohort 1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'country': 'China', 'facility': 'Shanghai Dongfang Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Mandy Xue', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hutchmed'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hutchmed', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}