A Phase 1, Open-Label, Non-Randomized, Dose-Escalating Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of TAS-119 in Patients with Advanced Solid Tumours
Research type
Research Study
Full title
A Phase 1, Open-Label, Non-Randomized, Dose-Escalating Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of TAS-119 as Monotherapy and in Combination With Docetaxel in Patients with Advanced Solid Tumours
IRAS ID
156436
Contact name
Johann de Bono
Contact email
Sponsor organisation
Taiho Oncology, Inc.
Eudract number
2014-001272-63
Research summary
The experimental drug TAS119 is an inhibitor of a protein that is involved in cell division, called Aurora A kinase. Increased numbers and/or increased activity of the Aurora A kinase gene has been reported in various tumour types including breast, lung, gastro oesophageal, bladder, ovary, prostate, pancreas and haematological malignancies.
This study will look at how TAS-119 affects the body of a patient and their cancer both when given on its own (monotherapy) and in combination with an approved drug called docetaxel.
Results from this study aim to show the doses of TAS-119 that will be useful and tolerable in both monotherapy and in combination therapy. The study is divided into two main parts, Part 1 will explore the effects of TAS-119 in monotherapy and Part 2 will explore the effects of TAS-119 when given with docetaxel. The study will be conducted at 2 centres, the Royal Marsden Hospital in the UK and the Erasmus MC Cancer Institute in the Netherlands.
Each part if the study is divided into two phases. The first phase will be a dose escalation phase which aims to find the maximum tolerated dose of TAS-119 both given as monotherapy and in combination with docetaxel. The second phase of the study will be an expansion phase where patients will be treated at the recommended phase 2 dose.
It is expected that approximately 190 patients in total will be enrolled. Approximately 98 patients will be enrolled into Part 1 of the study (monotherapy) with up to 26 of these in expansion phase and approximately 92 patients will be enrolled into Part 2 (combination) with up to 26 of these being enrolled into the expansion phase.REC name
London - Central Research Ethics Committee
REC reference
14/LO/1081
Date of REC Opinion
21 Jul 2014
REC opinion
Further Information Favourable Opinion