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

NCT05080361 | Unknown FDA Drug

• 1 other identifier: BRAFREC
• Study Type: observational
• Target: 16,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• Recurrence rate

  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

  Up to the date of the individual case safety report notification in VigiBase(r), assessed up to 10 years

Secondary Outcomes (3)

• Comparison of rechallenge and non-rechallenge cases

  Up to 10 years

• 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

• 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

Study Arms (1)

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

Interventions

BRAF inhibitor DRUG

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

Also known as: MEK inhibitor

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

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• MEKi monotherapy cases
• Cases concurrently reporting on immune checkpoint inhibitor therapies

Sponsors & Collaborators

• University Hospital, Caen: lead

MeSH Terms

Conditions

Neoplasms

Interventions

MEK inhibitor I

Study Officials

• Charles Dolladille

  University Hospital, Caen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: October 15, 2021
• Study Start: January 1, 2011
• Primary Completion: March 1, 2021
• Study Completion: December 1, 2021
• Last Updated: October 15, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share