VEGF Receptor Tyrosine Kinase Inhibitor Axitinib in Children With Recurrent or Refractory Solid Tumors
Status:
Completed
Trial end date:
2017-10-19
Target enrollment:
Participant gender:
Summary
This trial will be the first study of axitinib in children and adolescents. The primary
objective of this Phase 1 trial is to determine a maximum tolerated dose (MTD) or recommended
Phase 2 dose (RP2D) of axitinib in pediatric patients with refractory solid tumors.
Additional objectives include measurement of pharmacokinetic and pharmacodynamic parameters,
description of the toxicity profile of this agent in children and adolescents, and assessment
of response within the confines of a Phase 1 trial. A standard rolling 6 design will be used
for dose escalation. Further development of axitinib will focus on development of a joint
cooperative group (COG/ECOG) Phase 2 study of axitinib in pediatric, adolescent and young
adult translocation renal cell carcinoma.