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

Cancer Clinical Trial

— BRAFREC  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05080361
• Other study ID #: BRAFREC
• Status: Active, not recruiting
• Start date: January 1, 2011
• Est. completion date: December 1, 2021

Study information

• Verified date: April 2021
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 16000
• Est. completion date: December 1, 2021
• Est. primary completion date: March 1, 2021
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Comparison of rechallenge and non-rechallenge cases	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).	Up to 10 years
Secondary	Factors associated with the recurrence after a rechallenge among informative rechallenges (i.e. variables associated with a higher recurrence rate, in a regression model)	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.	Up to 10 years
Secondary	Rate of occurrence of a different AE after a monotherapy or combination therapy rechallenge (among informative rechallenges)	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	Up to the date of the individual case safety report notification in VigiBase(r), assessed up to 10 years