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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
TAS-116 is an oral heat shock protein 90 (HSP90) inhibitor investigated in 3 dosing regimens (QD, QOD, 5 days on 2 days off) in patients with advanced solid tumor and then at one dose schedule in advanced breast and lung cancer.
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
Milan, 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
...and 2 more locations
Number of patients experiencing Dose Limiting Toxicity graded according to CTCAE Version 4.03, observed in the Cycle 1 in order to meet the objective of assessment of the MTD of TAS-116 (Part A)
Time frame: 21 days in Cycle 1
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (Parts A, B and C)
Time frame: Safety monitoring will begin at the informed consent obtained and continue up to 28 days after the last dose of TAS-116 or until new anti-tumor therapy, whichever is earlier.
Objective Response Rate using Response Evaluation Criteria in Solid Tumors 1.1 (RECIST) (Part C)
Time frame: Up to 2 Years
Maximum Plasma Concentration (Cmax) after administration of TAS-116 (Parts A and B)
Time frame: 21 days in Cycle 1
Area under the plasma drug concentration-time curve (AUC) after administration of TAS-116 (Parts A and B)
Time frame: 21 days in Cycle 1
Disease Control Rate using RECIST 1.1 (Parts A, B, and C)
Time frame: Up to last participant completes at least 6 months
Duration of Response (Part C)
Time frame: Up to last participant completes at least 6 months
Progression Free Survival (Part C)
Time frame: Up to last participant completes at least 6 months
Overall Survival
Time frame: Up to last participant completes at least 6 months
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