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

NCT ID: NCT05080361

Last Updated: 2021-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

16000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-01

Study Completion Date

2021-12-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

BRAF inhibitor

Intervention Type DRUG

Reports of adverse events occurring in patients treated with at least one BRAFi or MEKi as reported in the individual case safety reports.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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MEK inhibitor

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Charles Dolladille

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Caen

Other Identifiers

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BRAFREC

Identifier Type: -

Identifier Source: org_study_id