Ignite Creation Date:
2025-12-24 @ 11:52 AM
Ignite Modification Date:
2026-01-29 @ 2:08 PM
Study NCT ID:
NCT05080361
Status:
UNKNOWN
Last Update Posted:
2021-10-15
First Post:
2021-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rechallenge of BRAF +/- MEK Inhibitors Following an Adverse Event in Patients With Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000610759', 'term': 'MEK inhibitor I'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2011-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-13', 'studyFirstSubmitDate': '2021-04-28', 'studyFirstSubmitQcDate': '2021-10-13', 'lastUpdatePostDateStruct': {'date': '2021-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence rate', 'timeFrame': 'Up to the date of the individual case safety report notification in VigiBase(r), assessed up to 10 years', 'description': 'The primary outcome is the rate of recurrence of the same AE after a BRAFi+/- MEKi rechallenge among informative rechallenges The recurrence rate will be obtained by dividing the number of cases with an AE recurrence by the number of informative rechallenges and will be expressed as a percentage'}], 'secondaryOutcomes': [{'measure': 'Comparison of rechallenge and non-rechallenge cases', 'timeFrame': 'Up to 10 years', 'description': 'Baseline characteristics (initial adverse event, cancer indication, age, sex) Measurements are the Medical Dictionary for Regulatory Activities preferred terms for adverse events and cancer indications, the Anatomical and Therapeutical Class for drugs. Age is categorized (18-45, 45-64, 65-74, \\> 75y.o.), sex (male, female).'}, {'measure': 'Factors associated with the recurrence after a rechallenge among informative rechallenges (i.e. variables associated with a higher recurrence rate, in a regression model)', 'timeFrame': 'Up to 10 years', 'description': 'Across baseline characteristics (initial adverse event, cancer indication, age, sex). Measurements are the Medical Dictionary for Regulatory Activities preferred terms for adverse events and cancer indications, the Anatomical and Therapeutical Class for drugs. Age is categorized (18-45, 45-64, 65-74, \\> 75y.o.), sex (male, female).\n\nThe recurrence is defined as a second occurrence of an initial adverse event after the treatment was reintroduced. It is a dichotomous outcome.\n\nData will be analyzed through a regression model, so as to determinate which of these covariates are associated with a higher recurrence rate.'}, {'measure': 'Rate of occurrence of a different AE after a monotherapy or combination therapy rechallenge (among informative rechallenges)', 'timeFrame': 'Up to the date of the individual case safety report notification in VigiBase(r), assessed up to 10 years', 'description': 'The occurrence rate will be obtained by dividing the number of cases with another AE that occurred following a treatment rechallenge by the number of informative rechallenges and will be expressed as a percentage'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': 'Very little data are published on the safety of a rechallenge with a BRAF inhibitor or combination of BRAF and MEK inhibitor (BRAFi and MEKi) after an adverse event (AE). This study aimed at identifying the recurrence rate of the same AE after a BRAFi +/- MEKi rechallenge in patients with cancer and the factors associated to the recurrence.', 'detailedDescription': 'This is an observational, cross-sectional, pharmacovigilance cohort study. AEs were extracted from safety reports from the World Health Organization database VigiBase®, to evaluate the safety of a rechallenge with a BRAF inhibitor or combination of BRAF and MEK inhibitor (BRAFi and MEKi) after an adverse event (AE) in patients with cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population is made of individual case safety reports from the World Health Organization pharmacovigilance database VigiBase, where patients had an adverse event following BRAF+/-MEKi therapy intakes.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All consecutive AE cases associated with BRAFi and MEKi therapy. Combination therapy cases, where BRAFi were concurrently reported with MEKi will be identified, as well as the combination therapy regimen (V+C, D+T, E+B). We will not study MEKi monotherapy cases\n\nExclusion Criteria:\n\n* MEKi monotherapy cases\n* Cases concurrently reporting on immune checkpoint inhibitor therapies'}, 'identificationModule': {'nctId': 'NCT05080361', 'acronym': 'BRAFREC', 'briefTitle': 'Rechallenge of BRAF +/- MEK Inhibitors Following an Adverse Event in Patients With Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Caen'}, 'officialTitle': 'Rechallenge of Rapidly Accelerated Fibrosarcoma B-type (BRAF) +/- Mitogen-activated Extracellular Signal-regulated Kinase (MEK) Inhibitors Following an Adverse Event in Patients With Cancer', 'orgStudyIdInfo': {'id': 'BRAFREC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Reports of adverse events associated with the use of BRAF +/- MEK inhibitors', 'description': 'Reports of adverse event (individual case safety reports) from Vigibase, the World Health Organization pharmacovigilance database related to the use of BRAF +/- MEK inhibitors from inception (1986) until March, 1, 2021 will be extracted.\n\nCases concurrently reporting on immune checkpoint inhibitor therapies will be excluded.', 'interventionNames': ['Drug: BRAF inhibitor']}], 'interventions': [{'name': 'BRAF inhibitor', 'type': 'DRUG', 'otherNames': ['MEK inhibitor'], 'description': 'Reports of adverse events occurring in patients treated with at least one BRAFi or MEKi as reported in the individual case safety reports.', 'armGroupLabels': ['Reports of adverse events associated with the use of BRAF +/- MEK inhibitors']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Charles Dolladille', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Caen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data for this study are available at http://www.vigiacess.org/. Dissemination to study participants / researchers is not possible outside of the dedicated website.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Caen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}