A Study of TAS-116 in Patients With Solid Tumors
- Registration Number
- NCT02965885
- Lead Sponsor
- Taiho Oncology, Inc.
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31
-
Male or females with an age ≥ 18 years (≥ 20 years in Japan)
-
Patients with histological- or cytological-confirmed, advanced unresectable breast, gastric, or non-small cell lung cancer, who have progressed on (or not been able to tolerate) standard therapy or for whom no standard anticancer therapy exists.
a. Part C: Only the following subtype of tumors with the molecular/genetic alterations will be enrolled: HER2 positive MBC Advanced NSCLC, harboring EGFR mutations after progression on osimertinib Advanced NSCLC, harboring ALK translocations after treatment with alectinib or at least 2 ALK inhibitors
-
Has At least one measurable lesion as defined by RECIST criteria
-
Is able to take medications orally (e.g., no feeding tube).
-
Is able to agree to and sign informed consent and to comply with the protocol
-
Has adequate organ function
- Has a serious illness or medical condition(s)
- Has received treatment with any prescribed treatments within specified time frames prior to study drug administration
- Significant ophthalmologic abnormality,
- Impaired cardiac function or clinically significant cardiac disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TAS-116 TAS-116 -
- Primary Outcome Measures
Name Time Method Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (Parts A, B and C) 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. 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) 21 days in Cycle 1 Objective Response Rate using Response Evaluation Criteria in Solid Tumors 1.1 (RECIST) (Part C) Up to 2 Years
- Secondary Outcome Measures
Name Time Method Progression Free Survival (Part C) Up to last participant completes at least 6 months Maximum Plasma Concentration (Cmax) after administration of TAS-116 (Parts A and B) 21 days in Cycle 1 Area under the plasma drug concentration-time curve (AUC) after administration of TAS-116 (Parts A and B) 21 days in Cycle 1 Disease Control Rate using RECIST 1.1 (Parts A, B, and C) Up to last participant completes at least 6 months Duration of Response (Part C) Up to last participant completes at least 6 months Overall Survival Up to last participant completes at least 6 months
Trial Locations
- Locations (12)
University Hospitals Case Medical Center
🇺🇸Cleveland, Ohio, United States
Regina Elena National Cancer Institute
🇮🇹Roma, Italy
The Christie NHS Foundation Trust Institute of Cancer Sciences, University of Manchester
🇬🇧Manchester, United Kingdom
Sarah Cannon Research Institute UK
🇬🇧London, United Kingdom
Istituto Europeo di Oncologia , Sviluppo di Nuovi Farmaci per Terapie Innovative
🇮🇹Milano, Italy
Policlinico S.Orsola-Malpighi, U.O. Oncologia Medica
🇮🇹Bologna, Italy
US Oncology - Virginia Cancer Specialists, P.C.
🇺🇸Fairfax, Virginia, United States
Division of Cancer Studies, Kings College London
🇬🇧London, United Kingdom
Azienda Ospedaliero-Universitaria Policlinico-Vittorio Emanuele Oncologia Medica
🇮🇹Catania, Italy
Northern Centre for Cancer Care
🇬🇧Newcastle Upon Tyne, England, United Kingdom
Royal Marsden
🇬🇧Sutton, United Kingdom
Greenville Health System, Institute for Translational Oncology Research
🇺🇸Greenville, South Carolina, United States