A Phase I Study of an MPS1 Inhibitor (BAY 1217389) in Combination with Paclitaxel Using a Novel Randomized Continual Reassessment Method for Dose Escalation.
Florence AtrafiOliver BoixVivek SubbiahJennifer R DiamondSant P ChawlaAnthony W TolcherPatricia M LoRussoJoseph P EderMartin GutierrezKumar SankhalaPrabhu RajagopalanIsabelle GenvresseSimon LangerRon H J MathijssenJaap VerweijIngmar BrunsMartijn Paul LolkemaPublished in: Clinical cancer research : an official journal of the American Association for Cancer Research (2021)
The combination of BAY with paclitaxel was associated with considerable toxicity without a therapeutic window. However, the use of the rCRM design enabled us to determine the exposure-toxicity relation for BAY. Therefore, we propose that the rCRM could improve dose determination in phase I trials that combine agents with overlapping toxicities.