Perspectives | Published:

Molecular prescreening to select patient population in early clinical trials

Nature Reviews Clinical Oncology volume 9, pages 359366 (2012) | Download Citation

Abstract

The efficacy of targeted therapies in patient populations selected for treatment on the basis of the molecular features of their tumours is shifting the current focus of treatment to biomarker-driven clinical trials. Phase I trials provide an arena for early hypothesis testing, examining not only safety and toxicity, but also target engagement, biologically effective dosages, and the appropriate patient population. In this Perspectives article, we describe this new trend in early drug development, establishing the different approaches for building a pre-screening programme in an academic institution that is involved in early drug development. Our experience establishing the phase I programme at Vall d'Hebrón serves as an example of how these approaches can be integrated in ongoing trials, and we believe these considerations will help others to implement similar programmes in their institutions.

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Acknowledgements

We thank Claudia Aura, Javier Hernandez, Jose Jimenez, Ludmila Prudkin, Elisabeth Llonch, Laurence Le Breton, Gessami Sanchez-Oller, Debora Moreno, Nuria Murtra, Irene Braña, Begoña Graña, Gemma Sala, Susana Muñoz, and many others for their work in the design, implementation and organization of the pre-screening programme. We also thank Javier Cortés, Joan Carles, Enriqueta Felip, Josep María del Campo, Joan Seoane, Violeta Serra, Leticia de Mattos, and Mafalda Oliveira for their support to this programme and scientific input in the design of it. We thank Malte Peters, Michael Goldbrunner, and Wolfgang Wick from Novartis for their commitment in prescreening patients for PI3K inhibitors. We also thank Joann Aaron (freelance writer, Houston, US) for scientific editing of this article.

Author information

Affiliations

  1. Medical Oncology Department, Vall d'Hebrón University Hospital, Spain

    • Jordi Rodón
    • , Cristina Saura
    • , Rodrigo Dienstmann
    •  & Josep Tabernero
  2.  Pathology Department, Vall d'Hebrón University Hospital, Spain

    • Santiago Ramón y Cajal
  3.  Vall d'Hebrón Institute of Oncology, Passeig Vall d'Hebrón, 119–129, 08035 Barcelona, Spain

    • Ana Vivancos
    •  & José Baselga

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Contributions

All authors contributed to the discussion of content and reviewed and edited the manuscript before submission. J. Rodón, R. Dienstmann and J. Tabernero researched data for the article and contributed significantly to the writing of the manuscript before submission. A. Vivancos also contributed significantly to the writing. J. Baselga, S. Ramón y Cajal and C. Saura contributed to researching the data for the article.

Competing interests

Baselga declares he is a consultant and he serves as a scientific advisor of Aragon, AstraZeneca, Bayer-Onix, Chugai, Constellation, Exelixis, Intellikine, Merck, Novartis, Roche-Genentech, Sanofi. J Tabernero declares he is a consultant and receives grant support from Novartis and Roche-Genentech. The other authors declare no competing interests.

Corresponding author

Correspondence to Jordi Rodón.

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DOI

https://doi.org/10.1038/nrclinonc.2012.48

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