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BRAFREC: Rechallenge of BRAF +/- MEK Inhibitors Following an Adverse Event in Patients With Cancer

Sponsor
University Hospital, Caen (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05080361
Collaborator
(none)
16,000
Enrollment
131
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: BRAF inhibitor

Detailed Description

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
16000 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Rechallenge of Rapidly Accelerated Fibrosarcoma B-type (BRAF) +/- Mitogen-activated Extracellular Signal-regulated Kinase (MEK) Inhibitors Following an Adverse Event in Patients With Cancer
Actual Study Start Date :
Jan 1, 2011
Actual Primary Completion Date :
Mar 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Reports of adverse events associated with the use of BRAF +/- MEK inhibitors

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. Cases concurrently reporting on immune checkpoint inhibitor therapies will be excluded.

Drug: BRAF inhibitor
Reports of adverse events occurring in patients treated with at least one BRAFi or MEKi as reported in the individual case safety reports.
Other Names:
  • MEK inhibitor

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Recurrence rate [Up to the date of the individual case safety report notification in VigiBase(r), assessed up to 10 years]

      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

    Secondary Outcome Measures

    1. Comparison of rechallenge and non-rechallenge cases [Up to 10 years]

      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).

    2. Factors associated with the recurrence after a rechallenge among informative rechallenges (i.e. variables associated with a higher recurrence rate, in a regression model) [Up to 10 years]

      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). The recurrence is defined as a second occurrence of an initial adverse event after the treatment was reintroduced. It is a dichotomous outcome. Data will be analyzed through a regression model, so as to determinate which of these covariates are associated with a higher recurrence rate.

    3. Rate of occurrence of a different AE after a monotherapy or combination therapy rechallenge (among informative rechallenges) [Up to the date of the individual case safety report notification in VigiBase(r), assessed up to 10 years]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • 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
    Exclusion Criteria:

    • MEKi monotherapy cases

    • Cases concurrently reporting on immune checkpoint inhibitor therapies

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University Hospital, Caen

    Investigators

    • Principal Investigator: Charles Dolladille, University Hospital, Caen

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Caen
    ClinicalTrials.gov Identifier:
    NCT05080361
    Other Study ID Numbers:
    • BRAFREC
    First Posted:
    Oct 15, 2021
    Last Update Posted:
    Oct 15, 2021
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No

    Study Results

    No Results Posted as of Oct 15, 2021