Drug Development in Oncology: Classical Cytotoxics and Molecularly Targeted Agents

Overview

Journal Br J Clin Pharmacol

Specialty Pharmacology

Date 2006 Jul 18

PMID 16842375

Citations 54

Authors

Shivaani Kummar

Martin Gutierrez

James H Doroshow

Anthony J Murgo

Affiliations

Soon will be listed here.

Abstract

There is an apparent need to improve the speed and efficiency of oncological drug development. Furthermore, strategies traditionally applied to the development of standard cytotoxic chemotherapy may not be appropriate for molecularly targeted agents. This is particularly the case for exploratory Phase 1 and 2 trials. Conventional approaches to determine dose based on maximum tolerability and efficacy based on objective tumour response may not be suitable for targeted agents, since many of them have a wide therapeutic index and inhibit tumour growth without demonstrable cytotoxicity. Instead, exploratory trials of targeted agents may have to focus on other end-points such as pharmacological effects and disease stabilization. Thus, there is an increasing interest in making the best possible use of biomarkers and pharmacogenomics in early phases of drug development.

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