Determinants of the recommended phase 2 dose of molecular targeted agents

CONCLUSIONSIn the past decade, there has been a dominance of a nonclassical approach using multiple endpoints with or without toxicity or single nontoxicity endpoints to define RPTD in MTA monotherapy phase 1 trials. Nonclassically defined RP2Ds for MTAs appear to be associated with a higher rate of FDA drug approval. Cancer 2017. © 2017 American Cancer Society.

Source: Cancer - February 9, 2017 Category: Cancer & Oncology Authors: Aaron R. Hansen, Natalie Cook, Eitan Amir, Lillian L. Siu, Albiruni Ryan Abdul Razak Tags: Original Article Source Type: research