Rechallenge of BRAF +/- MEK Inhibitors Following an Adverse Event in Patients With Cancer
NCT05080361 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 16000
Last updated 2021-10-15
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
Interventions
- 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.
Sponsors & Collaborators
-
University Hospital, Caen
lead OTHER
Principal Investigators
-
Charles Dolladille · University Hospital, Caen
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-01-01
- Primary Completion
- 2021-03-01
- Completion
- 2021-12-01
- FDA Drug
- Yes
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