A study of axitinib, a VEGF receptor tyrosine kinase inhibitor, in children and adolescents with recurrent or refractory solid tumors: A Children's Oncology Group phase 1 and pilot consortium trial (ADVL1315).

ABSTRACT:

Background

Axitinib is an oral small molecule that inhibits receptor tyrosine kinases vascular endothelial growth factor receptors 1 to 3. A phase 1 and pharmacokinetic (PK) trial evaluating axitinib was conducted in children with refractory solid tumors.

Methods

Axitinib was administered orally twice daily in continuous 28-day cycles. Dose levels (2.4 mg/m² /dose and 3.2 mg/m² /dose) were evaluated using a rolling 6 design. Serial PKs (cycle 1, days 1 and 8) and exploratory biomarkers were analyzed.

Results

A total of 19 patients were enrolled; 1 patient was ineligible due to inadequate time having elapsed from prior therapy. The median age of the patients was 13.5 years (range, 5-17 years). Two of 5 patients who were treated at dose level 2 exp

SUBMITTER: Geller JI 

PROVIDER: S-EPMC6289772 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature