Phase 1 study of alisertib (MLN8237) and weekly irinotecan in adults with advanced solid tumors.

ABSTRACT:

Purpose

Aurora kinases are overexpressed or amplified in numerous malignancies. This study was designed to determine the safety and tolerability of the Aurora A kinase inhibitor alisertib (MLN8237) when combined with weekly irinotecan.

Methods

In this single-center phase 1 study, adult patients with refractory advanced solid tumors received 100 mg/m² irinotecan intravenously on day 1 and 8 of a 21-day cycle. Alisertib at planned escalating dose levels of 20-60 mg was administered orally twice per day on days 1-3 and 8-10. Patients homozygous for UGT1A1*28 were excluded. The primary objective was the safety of alisertib when combined with irinotecan to determine the maximum tolerated dose (MTD). Secondary objectives included overall response rate by RECIST and phar

SUBMITTER: Semrad TJ 

PROVIDER: S-EPMC8259450 | biostudies-literature | 2021 Aug

REPOSITORIES: biostudies-literature