Impact of race on dose selection of molecular-targeted agents in early-phase oncology trials.

ABSTRACT:

Background

We examined the impact of race on the maximum tolerated doses (MTD) and final approved doses (FAD) of single-agent molecular-targeted agents (MTA) in North America/Europe (NA/EU) and Asia.

Methods

We searched PubMed and regulatory databases to identify targeted drugs approved globally and compared their FAD and MTD in corresponding phase I/II studies conducted separately in NA/EU and Asia. To evaluate this further, we conducted parallel, prospective, first-in-human studies of DS-7423, a dual PI3K/mTOR inhibitor, in patients with advanced solid tumours in the US and Japan. We pooled and compared the pharmacokinetics (PK), pharmacodynamics (PD), toxicity, and efficacy between these populations.

Results

17 MTA were approved in NA/EU and Asia from 2001 to 2015.

SUBMITTER: Yokota T 

PROVIDER: S-EPMC6008299 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature