A Phase II Study of Alisertib in Children with Recurrent/Refractory Solid Tumors or Leukemia: Children's Oncology Group Phase I and Pilot Consortium (ADVL0921).
Yael P MosséElizabeth FoxDavid C HallJoel M ReidStephanie L SafgrenHernan CarolRichard B LockPeter J HoughtonMalcolm A SmithDavid HallDonald A BarkauskasMark KrailoStephan D VossStacey L BergSusan M BlaneyBrenda J WeigelPublished in: Clinical cancer research : an official journal of the American Association for Cancer Research (2019)
Despite alisertib activity in pediatric xenograft models and cogent pharmacokinetic-pharmacodynamic relationships in preclinical models and adults, the objective response rate in children and adolescents receiving single-agent alisertib was less than 5%.