Phase 1 study of sorafenib and irinotecan in pediatric patients with relapsed or refractory solid tumors.

ABSTRACT:

Background

Sorafenib,an orally bioavailable, multitarget tyrosine kinase inhibitor, and irinotecan, a topoisomerase I inhibitor, have demonstrated activity in pediatric and adult malignancies. We evaluated the toxicity, pharmacokinetic (PK), and pharmacogenomic (PGX) profile of sorafenib with irinotecan in children with relapsed or refractory solid tumors and assessed the feasibility of incorporating patient-reported outcome (PRO) measures as an adjunct to traditional endpoints.

Methods

Sorafenib, continuous oral twice daily dosing, was administered with irinotecan, orally, once daily days 1-5, repeated every 21 days (NCT01518413). Based on tolerability, escalation of sorafenib followed by escalation of irinotecan was planned. Three patients were initially enrolled at each d

SUBMITTER: Meany HJ 

PROVIDER: S-EPMC10197018 | biostudies-literature | 2021 Nov

REPOSITORIES: biostudies-literature