A Study of TAS-116 in Patients With Solid Tumors
Completed · Phase 1
Conditions studied: Advanced Solid Tumors
In brief
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.
Key facts
- Study ID
- NCT02965885
- Run by
- Taiho Oncology, Inc.
- People needed
- 31
- Starts
- 2017-07-10
- Expected to finish
- 2019-05-03
- Last updated by the study team
- 2024-09-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- 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
- The Christie NHS Foundation Trust Institute of Cancer Sciences, University of Manchester — Manchester, United Kingdom
- Royal Marsden — Sutton, United Kingdom
Full record on ClinicalTrials.gov
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