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Review
. 2009 May;6(5):259-65.
doi: 10.1038/nrclinonc.2009.38.

Next generation oncology drug development: opportunities and challenges

Martin E Gutierrez  1 , Shivaani Kummar, Giuseppe Giaccone
Affiliations
Review

Next generation oncology drug development: opportunities and challenges

Martin E Gutierrez et al. Nat Rev Clin Oncol. 2009 May.

Abstract

The optimal development of novel molecularly targeted agents for the treatment of cancer requires a re-evaluation of the current drug development paradigm. Selection of patients, optimal biologic dose versus maximum tolerated dose, definition of response and clinical benefit and trial designs that address these considerations are the focus of debate in the field of early cancer therapeutics. We present a review of the opportunities and challenges facing drug development in oncology through the phases of clinical development starting with first-in-human trials.

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Figures

Figure 1 |
Figure 1 |
Effect of selection of patients in phase III studies. a | Model for a phase III trial in which 100% of patients show a treatment effect. b | Model for a phase III trial in which 25% of patients show a treatment effect. Permission obtained from the American Society of Clinical Oncology © Pegram, M. D. et al. Targeted therapy: wave of the future. J. Clin. Oncol. 23, 1776–1781 (2005).
Figure 2 |
Figure 2 |
Bidimensional tumor measurements in a randomized discontinuation phase II clinical trial of 193 patients. Permission obtained from the American Society of Clinical Oncology © Ratain, M. J. et al. Phase II placebo-controlled randomized discontinuation trial of sorafenib in patients with metastatic renal cell carcinoma. J. Clin. Oncol. 24, 2505–2512 (2006).
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