Case Studies

Phase I QTc Eribulin

When developing new treatments in oncology, given the relative toxicity of the category of drug, it is important to pay particular attention to the effect of the medication on cardiac function.

OBJECTIVES

The purpose of this study was to investigate the impact of eribulin mesylate on cardiac repolarization in patients with advanced solid tumors.

DESIGN

This study was an open-label, multicenter, single-arm Phase I trial with patients with solid tumors & Lymphoma.

Biotrial was selected to carry out feasibility, full project management and monitoring as well as regulatory support, clinical investigation, logistics and data management.

 

 

With significant experience in data capture and reading, for intensive ECG capture days, Biotrial’s cardiac safety experts were available to assure that the quality of the recordings were maintained.

Five sites in Biotrial’s network were selected to participate in the study and were closely monitored by our dedicated team of Oncology CRAs along with our specialized Early Phase Nurses. Patient recruitment was achieved 3 months in advance, allowing the trial to be completed more quickly than originally anticipated.

 

RESULTS

In this study, it was confirmed that eribulin mesylate presents an acceptable safety profile as well as there being no correlation between QT prolongation and eribulin concentration.

Study data was incorporated into the MMA authorization file for Eribulin (Halaven®) submitted to the FDA.