Spots Global Cancer Trial Database for A Study of TAS-116 in Patients With Solid Tumors
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Trial Identification
Brief Title: A Study of TAS-116 in Patients With Solid Tumors
Official Title: A Phase IA/IB Study Evaluating TAS-116 in Patients With Advanced Solid Tumors
Study ID: NCT02965885
Conditions
Interventions
Study Description
Brief Summary: A First-in-Human (FIH) study of TAS-116 in patients with advanced solid tumors was first initiated in Japan in April 2014 and has been ongoing since then. The study consists of a dose escalation phase and a dose expansion phase. Three dosing regimens of TAS-116, once daily (QD), every other day (QOD) and 5 days on/2 days off regimens in 21-day cycles, are being evaluated. This phase I study is also planned to enroll patients with advanced solid tumors in UK to confirm the MTD, safety, tolerability, and pharmacokinetics of TAS-116 in a Western patient population in the dose expansion phase. In addition, patients with HER2+ MBC, NSCLC harboring EGFR mutations or NSCLC harbouring ALK translocations will be further evaluated for safety, tolerability, and efficacy in 3 separate cohorts at recommended dose of TAS-116 on the 5 days on/2 days off regimen.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University Hospitals Case Medical Center, Cleveland, Ohio, United States
Greenville Health System, Institute for Translational Oncology Research, Greenville, South Carolina, United States
US Oncology - Virginia Cancer Specialists, P.C., Fairfax, Virginia, United States
Policlinico S.Orsola-Malpighi, U.O. Oncologia Medica, Bologna, , Italy
Azienda Ospedaliero-Universitaria Policlinico-Vittorio Emanuele Oncologia Medica, Catania, , Italy
Istituto Europeo di Oncologia , Sviluppo di Nuovi Farmaci per Terapie Innovative, Milano, , Italy
Regina Elena National Cancer Institute, Roma, , Italy
Northern Centre for Cancer Care, Newcastle Upon Tyne, England, United Kingdom
Division of Cancer Studies, Kings College London, London, , United Kingdom
Sarah Cannon Research Institute UK, London, , United Kingdom
The Christie NHS Foundation Trust Institute of Cancer Sciences, University of Manchester, Manchester, , United Kingdom
Royal Marsden, Sutton, , United Kingdom
Contact Details
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