The Effect of Hepatic Impairment on Outcomes in Phase I Clinical Trials in Cancer Subjects.

ABSTRACT:

Purpose

The NCI Cancer Therapy Evaluation Program sponsors hepatic dysfunction phase I clinical trials (HDCT) and phase 1 clinical trials (P1CT) to determine safe doses and schedules of antineoplastic therapeutics. We sought to compare clinical outcomes between these trial types while stratifying by hepatotoxic agents.

Experimental design

Individual subject data were extracted from the records of 51 NCI-sponsored HDCT and P1CT. The NCI's Organ Dysfunction Working Group's hepatic impairment categorization and two drug-induced liver injury (DILI) scales (FDA R ratio and Hy's law) were used to classify subjects. The number of cycles administered and treatment discontinuation reason were also evaluated and compared between groups.

Results

There were 513 and 1,328 subjects

SUBMITTER: Mansfield AS 

PROVIDER: S-EPMC5114163 | biostudies-literature | 2016 Nov

REPOSITORIES: biostudies-literature