Phase I en oncologie. Le défi de développer de nouveaux agents thérapeutiques à l’ère de la médecine personnalisée

Pharmaceutical Research and Manufacturers of America (phRMA). Medecines in development for cancer. 1987–2009. http://www.phrma.org. US Departement of Health and Human Services Food and Drug Administration. Innovation or stagnation: challenges and opportunity on the critical path to new medical products. US Department of Health and Human Services. 2004–7. http://www.fda.gov/oc/initiatives/criticalpath/withepaper.html. Andre, 2009, Molecular characterization of breast cancer with high-resolution oligonucleotide comparative genomic hybridization array, Clin Cancer Res, 15, 441, 10.1158/1078-0432.CCR-08-1791 Korn, 2004, Nontoxicity endpointds in phase I trial designs for targeted non cytotoxic agents, J Natl Cancer Inst, 96, 977, 10.1093/jnci/djh208 Von Hoff, 2009, Inhibition of hedgehog pathway in advanced basal-cell carcinoma, New Engl J Med, 361, 1164, 10.1056/NEJMoa0905360 Kwak, 2009, Clinical activity observed in a pgase I dose escalation trial of an aoral c-met and ALK inhibitor PF-02341066, Eur J Cancer Suppl, 7, 8, 10.1016/S1359-6349(09)72045-2 Kindersn, 2007, Phase 0 clinical trials in cancer drug development: from FDA guidance to clinical practice, Mol Interv, 7, 325, 10.1124/mi.7.6.9 Kummars, 2009, Phase 0 clinical trial of the poly(ADP ribose)polymerase inhibitor ABT-888 in patients with advanced malignacies, J Clin Oncol, 27, 2705, 10.1200/JCO.2008.19.7681 Wistuba, 2011, Methodological and practical challenges for personalized cancer therapies, Nat Rev Clin Oncol, 8, 135, 10.1038/nrclinonc.2011.2 Jayson, 2002, European Organisation for Research and Treatment of Cancer Biological Therapeutic Development Group. Molecular imaging and biological evaluation of HuMV833 anti-VEGF antibody: implications for trial design of antiangiogenic antibodies, Natl Cancer Inst, 94, 1484, 10.1093/jnci/94.19.1484