NCT05080361

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

Rechallenge of Rapidly Accelerated Fibrosarcoma B-type (BRAF) +/- Mitogen-activated Extracellular Signal-regulated Kinase (MEK) Inhibitors Following an Adverse Event in Patients With Cancer

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 16,000 (estimated)
• Sponsor: University Hospital, Caen · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: —

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.

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.

Conditions

• Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-01-01
• Primary completion: 2021-03-01
• Completion: 2021-12-01
• First posted: 2021-10-15
• Last updated: 2021-10-15

Regulatory

• FDA-regulated drug study