Advanced Solid Tumors Clinical Trial
Official title:
A Phase 1, Open-Label, Non-Randomized, Dose-Escalating Safety, Tolerability and Pharmacokinetic Study of TAS-119 in Combination With Paclitaxel in Patients With Advanced Solid Tumors
The purpose of this study is to determine the safety of TAS-119 and determine the most
appropriate dose in combination with Paclitaxel for subsequent studies in patients with
advanced solid tumors.
TAS-119 is a novel, selective Aurora A kinase inhibitor, which has previously been
demonstrated to enhance the activity of paclitaxel in preclinical studies
Background and rationale for study:
In nonclinical pharmacology studies TAS-119 significantly enhanced the antitumor activity of
the microtubule stabilizer paclitaxel and TAS-119 is being developed for use in combination
with paclitaxel.
TAS-119 selectively inhibits the kinase inhibitor Aurora A. AurA regulates cell division by
controlling the transition from G2 to M phase. Overexpression of AurA is associated with
resistance to taxanes.
The study will be conducted in two sequential phases:
Dose Escalation Phase with the purpose to determine the maximum tolerated dose and the
recommended Phase 2 dose of TAS-119 given in combination with paclitaxel
An Expansion Phase in which additional patients will be enrolled to further evaluate the
safety and preliminary efficacy of the recommended Phase 2 dose of TAS-119 in combination
with paclitaxel, during which a subgroup of patients will be evaluated for DDI between
paclitaxel and TAS-119 via PK assessment.
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