A multicenter, phase I, dose-escalation study to assess the safety, tolerability, and pharmacokinetics of etirinotecan pegol in patients with refractory solid tumors.

@article{Jameson2013AMP,
  title={A multicenter, phase I, dose-escalation study to assess the safety, tolerability, and pharmacokinetics of etirinotecan pegol in patients with refractory solid tumors.},
  author={Gayle S. Jameson and John Turner Hamm and Glen J. Weiss and Carlos A Alema{\~n}y and Stephen Anthony and Michele L. Basche and Ramesh K. Ramanathan and Mitesh J. Borad and Raoul Tibes and Allen Lee Cohn and Ioana Hinshaw and Robert M. Jotte and Lee S. Rosen and Ute R Hoch and Michael A. Eldon and Robert A Medve and Katrina Schroeder and Erica E. Bischoff White and Daniel D. Von Hoff},
  journal={Clinical cancer research : an official journal of the American Association for Cancer Research},
  year={2013},
  volume={19 1},
  pages={268-78}
}
PURPOSE This study was designed to establish the maximum tolerated dose (MTD) and to evaluate tolerability, pharmacokinetics, and antitumor activity of etirinotecan pegol. EXPERIMENTAL DESIGN Patients with refractory solid malignancies were enrolled and assigned to escalating-dose cohorts. Patients received 1 infusion of etirinotecan pegol weekly 3 times every 4 weeks (w × 3q4w), or every 14 days (q14d), or every 21 days (q21d), with MTD as the primary end point using a standard 3 + 3 design… CONTINUE READING