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Brief Title: An Investigation of TAS-119 Monotherapy
Official Title: A Phase I, Open-Label, Non-Randomized, Dose-Escalating Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of TAS-119 in Patients With Advanced Solid Tumors
Study ID: NCT02448589
Brief Summary: A Phase 1, Open-Label, Non-Randomized, Dose-Escalating Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of TAS-119 in Patients with Advanced Solid Tumors.
Detailed Description: This is a Phase 1, open-label, non-randomized, dose escalation study of TAS-119 evaluating the safety, tolerability, PK, pharmacogenomics, pharmacodynamics, and preliminary antitumour activity in patients with advanced and unresectable solid tumours. The study will evaluate TAS-119 monotherapy, employing two sequential phases. * A Dose Escalation Phase * An Expansion Phase
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University Hospitals - Seidman Cancer Center, Cleveland, Ohio, United States
San Raffaele Hospital, Milano, , Italy
Erasmus MC Cancer Institute, Rotterdam, , Netherlands
START MADRID-FJD, Hospital Fundación Jiménez Díaz, Madrid, , Spain
START Madrid Unidad de Ensayos Fase I, Madrid, , Spain
The Institute of Cancer Research, Sutton, Surrey, United Kingdom