Article
A phase I, open-label, two-stage study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of the oral AKT inhibitor GSK2141795 in patients with solid tumors.
Investigational new drugs - 1 Dec 2018
Aghajanian Carol, Bell-McGuinn Katherine M, Burris Howard A, Siu Lillian L, Stayner Lee-Ann, Wheler Jennifer J, Hong David S, Kurkjian Carla, Pant Shubham, Santiago-Walker Ademi, Gauvin Jennifer L, Antal Joyce M, Opalinska Joanna B, Morris Shannon R, Infante Jeffrey R
Abstract excerpt
Background We sought to determine the recommended phase II dose (RP2D) and schedule of GSK2141795, an oral pan-AKT kinase inhibitor. Patients and Methods Patients with solid tumors were enrolled in the dose-escalation phase. Pharmacokinetic (PK) analysis after a single dose (Cycle 0) informed dose escalation using accelerated dose titration. Once one grade 2 toxicity or dose-limiting toxicity was observed in...
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