Spots Global Cancer Trial Database for Rechallenge of BRAF +/- MEK Inhibitors Following an Adverse Event in Patients With Cancer
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Trial Identification
Brief Title: Rechallenge of BRAF +/- MEK Inhibitors Following an Adverse Event in Patients With Cancer
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
Study ID: NCT05080361
Conditions
Interventions
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.
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.
Keywords
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Contact Details
Name: Charles Dolladille
Affiliation: University Hospital, Caen
Role: PRINCIPAL_INVESTIGATOR
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