Phase I, Open-Label, Dose-Escalation Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of GSK2879552 in Relapsed/Refractory SCLC

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Presentation transcript:

Phase I, Open-Label, Dose-Escalation Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of GSK2879552 in Relapsed/Refractory SCLC Todd M. Bauer, MD, Benjamin Besse, MD PhD, Alex Martinez-Marti, MD, Jose Manuel Trigo, MD, Victor Moreno, MD, Pilar Garrido, MD PhD, Geraldine Ferron-Brady, PhD, Yuehui Wu, PhD, Jennifer Park, PharmD, Therese Collingwood, PhD, Ryan G. Kruger, PhD, Helai P. Mohammad, PhD, Marc S. Ballas, MD, Arindam Dhar, MD, Ramaswamy Govindan, MD Journal of Thoracic Oncology Volume 14, Issue 10, Pages 1828-1838 (October 2019) DOI: 10.1016/j.jtho.2019.06.021 Copyright © 2019 International Association for the Study of Lung Cancer Terms and Conditions

Figure 1 Mean (SD) GSK2879552 plasma concentration versus time after a single dose. Journal of Thoracic Oncology 2019 14, 1828-1838DOI: (10.1016/j.jtho.2019.06.021) Copyright © 2019 International Association for the Study of Lung Cancer Terms and Conditions

Figure 2 Time course of platelet count in individual patients who received 2 mg (A) or 3 mg (B) of GSK2879552 daily. Marks for dose interruptions (asterisk) and reductions (plus sign) show the dose administered on the day of the platelet counts but may not coincide with the exact day on which the dose interruption/reduction was started. The absence of a mark after a dose interruption means that treatment was restarted at the same dose. Grade (G) of toxicity is denoted as G1 to G4. No change in dose was required for G1. With G2 thrombocytopenia, the dose was either continued with no change or held for up to 2 weeks for toxicity to resolve to baseline or grade 1 or lower and then continued at the same dose, or reduced by no more than 25% if considered a dose-limiting toxicity. In the case of G3 and G4 events, the dose was held for up to 2 weeks for toxicity to resolve to baseline or grade 1 or lower and then reduced by no more than 25%; if recovery was achieved after 14 days, the patient was withdrawn. Journal of Thoracic Oncology 2019 14, 1828-1838DOI: (10.1016/j.jtho.2019.06.021) Copyright © 2019 International Association for the Study of Lung Cancer Terms and Conditions