Phase I dose-finding study of cabazitaxel administered weekly in patients with advanced solid tumours.

ABSTRACT:

Background

Cabazitaxel is approved in patients with metastatic hormone-refractory prostate cancer previously treated with a docetaxel-containing regimen. This study evaluated a weekly cabazitaxel dosing regimen. Primary objectives were to report dose-limiting toxicities (DLTs) and to determine the maximum tolerated dose (MTD). Efficacy, safety and pharmacokinetics were secondary objectives.

Methods

Cabazitaxel was administered weekly (1-hour intravenous infusion at 1.5-12 mg/m² doses) for the first 4 weeks of a 5-week cycle in patients with solid tumours. Monitoring of DLTs was used to determine the MTD and the recommended weekly dose.

Results

Thirty-one patients were enrolled. Two of six patients experienced DLTs at 12 mg/m², which was declared the MTD. Gastrointesti

SUBMITTER: Fumoleau P 

PROVIDER: S-EPMC3854123 | biostudies-literature | 2013 Oct

REPOSITORIES: biostudies-literature