Neoplasms Clinical Trial
Official title:
A Phase 1, Open-Label, Non-randomized, Dose-Escalating Safety, Tolerability, and Pharmacokinetic Study of TAS-114 in Combination With Capecitabine in Patients With Advanced Solid Tumors
The purpose of this exploratory study is to investigate the safety and determine the maximum tolerated dose (MTD) of TAS-114 in combination with capecitabine in patients with advanced solid tumors for which the patients have no available therapy likely to convey clinical benefit.
In animal models, co-administration of TAS 114 and capecitabine has shown antitumor effects
exceeding the maximum efficacy obtained by capecitabine alone. Developing a novel
chemotherapy based on the combined use of TAS-114 and capecitabine may fulfill the need for
more efficacious treatment for patients with advanced solid tumors.
The study, evaluating the safety, tolerability, pharmacokinetics, and preliminary antitumor
activity of the TAS-114/ capecitabine regimen in patients with advanced solid tumors, will be
conducted in two parts: a Dose-Escalation Phase (Part 1) to determine the MTD; and an
Expansion Phase (Part 2) to further evaluate the safety and preliminary efficacy with the
MTD.
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