Phase I Study of Apitolisib (GDC-0980), Dual Phosphatidylinositol-3-Kinase and Mammalian Target of Rapamycin Kinase Inhibitor, in Patients with Advanced Solid Tumors.

@article{Dolly2016PhaseIS,
  title={Phase I Study of Apitolisib (GDC-0980), Dual Phosphatidylinositol-3-Kinase and Mammalian Target of Rapamycin Kinase Inhibitor, in Patients with Advanced Solid Tumors.},
  author={Saoirse O. Dolly and Andrew J Wagner and Johanna C. Bendell and Hedy Lee Kindler and Lee Krug and Tanguy Y. Seiwert and Marjorie G Zauderer and Martijn P. J. Lolkema and Doris Apt and Ru-Fang Yeh and Jill O Fredrickson and Jill M. Spoerke and Hartmut Koeppen and J. A. thony Ware and Jennifer O’Hara Lauchle and Howard A. Burris and Johann S de Bono},
  journal={Clinical cancer research : an official journal of the American Association for Cancer Research},
  year={2016},
  volume={22 12},
  pages={
          2874-84
        }
}
PURPOSE This first-in-human phase I trial assessed the safety, tolerability, and preliminary antitumor activity of apitolisib (GDC-0980), a dual inhibitor of class I PI3K, and mTOR kinases. EXPERIMENTAL DESIGN Once-daily oral apitolisib was administered to patients with solid tumors for days 1 to 21 or 1 to 28 of 28-day cycles. Pharmacokinetic and pharmacodynamic parameters were assessed. RESULTS Overall, 120 patients were treated at doses between 2 and 70 mg. The commonest ≥G3 toxicities… CONTINUE READING
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