Drug development in oncology: Classical cytotoxics and molecularly targeted agents

Shivaani Kummar, Martin Gutierrez, James H. Doroshow, Anthony J. Murgo

Research output: Contribution to journalReview articlepeer-review

114 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)15-26
Number of pages12
JournalBritish Journal of Clinical Pharmacology
Volume62
Issue number1
DOIs
StatePublished - Jul 2006
Externally publishedYes

Keywords

  • Clinical trials
  • Drug development
  • Exploratory IND
  • Pharmacodynamics
  • Pharmacokinetics
  • Targeted therapeutics

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)

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