A phase I dose-escalation study of the safety and pharmacokinetics of a tablet formulation of voxtalisib, a phosphoinositide 3-kinase inhibitor, in patients with solid tumors

@article{Mehnert2017API,
  title={A phase I dose-escalation study of the safety and pharmacokinetics of a tablet formulation of voxtalisib, a phosphoinositide 3-kinase inhibitor, in patients with solid tumors},
  author={Janice M Mehnert and Gerald Edelman and Mark M Stein and Heather Camisa and Joanne Lager and Jean-François Dedieu and Anne-Fr{\'e}d{\'e}rique Ghuysen and Jyoti Sharma and Li Liu and Patricia M. LoRusso},
  journal={Investigational New Drugs},
  year={2017},
  volume={36},
  pages={36-44}
}
Background Voxtalisib, a PI3K/mTOR inhibitor, has shown antitumor activity in capsule formulation in patients with solid tumors. This Phase I study assessed safety and pharmacokinetics of voxtalisib administered as immediate-release tablets in patients with solid tumors (NCT01596270). Methods A “3 + 3” dose escalation design was used. Adverse events (AEs), pharmacokinetics (PK), food effect and tumor response were evaluated. Results Thirty-two patients received voxtalisib doses ranging from 50… CONTINUE READING