Tuxen, Ida Viller2; Jønson, Lars2; Santoni-Rugiu, Eric4; Hasselby, Jane Preuss2; Nielsen, Finn Cilius5; Lassen, Ulrik5
1 Department of Clinical Medicine, Department of Clinical Medicine, Faculty of Health and Medical Sciences, Københavns Universitet2 unknown3 Section of Diagnostic Sciences, Department of Clinical Medicine, Faculty of Health and Medical Sciences, Københavns Universitet4 Section of Diagnostic Sciences, Department of Clinical Medicine, Faculty of Health and Medical Sciences, Københavns Universitet5 Department of Clinical Medicine, Department of Clinical Medicine, Faculty of Health and Medical Sciences, Københavns Universitet
genomic screening in phase 1
Improvements in cancer genomics and tumor biology have reinforced the evidence of cancer development driven by numerous genomic alterations. Advanced genomics technology can be used to characterize genomic alterations that potentially drive tumor growth. With the possibility of screening thousands of genes simultaneously, personalized molecular medicine has become an option. New treatments are being investigated in phase 1 trials around the world. Traditionally, the goal of phase 1 studies was to determine the optimal dose and assess dose-limiting toxicity of a potential new experimental drug. Only a limited number of patients will benefit from the treatment. However, introducing genomic mapping to select patients for early clinical trials with targeted molecular therapy according to the genomic findings, may lead to a better outcome for the patient, an enrichment of phase 1 trials, and thereby accelerated drug development. The overall advantage is to determine which mutation profiles correlate with sensitivity or lack of resistance to specific targeted therapies. The utility and current limitations of genomic screening to guide selection to Phase 1 clinical trial will be discussed.
Journal review article
Apmis : Acta Pathologica, Microbiologica, Et Immunologica Scandinavica, 2014, Vol 122, Issue 8, p. 723-733
Chromosome Mapping; Clinical Trials, Phase I as Topic; DNA Mutational Analysis; Genetic Testing; Genetic Variation; Genomics; Humans; Individualized Medicine; Molecular Targeted Therapy; Neoplasms; Patient Selection; Tumor Markers, Biological