Phase I trials of antitumour agents: fundamental concepts.
Phase I trials are an important step in the development of new drugs. Because of the advancing knowledge of cancer's molecular biology, these trials offer an important platform for the development of new agents and also for patient treatment. Therefore, comprehension of their peculiar terminology and methodology are increasingly important. Our objectives were to review the fundamental concepts of phase I designs and to critically contextualise this type of study as a therapeutic option for patients with refractory cancer.
Cancer Institute of the State of São Paulo, São Paulo, Brazil.
Diego de Araujo
Dde A
Toloi
Cancer Institute of the State of São Paulo, São Paulo, Brazil.
Denis Leonardo Fontes
DL
Jardim
Cancer Institute of the State of São Paulo, São Paulo, Brazil.
Paulo Marcelo Gehm
PM
Hoff
Cancer Institute of the State of São Paulo, São Paulo, Brazil.
Rachel Simões Pimenta
RS
Riechelmann
combination therapy; molecular-targeted drugs; oncology; phase I study