Evaluating TAS-116 in patients with advanced solid tumours
Research type
Research Study
Full title
A Phase I Study Evaluating TAS-116 in Patients With Advanced Solid Tumors
IRAS ID
200170
Contact name
Udai Banerji
Contact email
Sponsor organisation
Taiho Oncology. Inc
Eudract number
2015-005328-24
Duration of Study in the UK
1 years, 4 months, 28 days
Research summary
This is a phase I study which will look at the safety of an experimental drug called TAS-116 which is thought to have the effect of suppressing the function of cancer cells in patients with solid tumours.
The purpose of this study is to investigate which side effects will occur and how frequently when TAS-116 is administered, and to use these side effects as a guide to determine the TAS-116 dose and administration method that are suitable for the treatment of patients. The study will also investigate the movement of the administered study medication inside the patient’s body (pharmacokinetics), the effects on the disease, and the indicators that can be used to predict these effects.
The medication will be given in 21 day cycles, administered in a schedule of 5 days on study drug and 2 days off, this schedule will continue to the end of each cycle.
The study is aimed at patients aged 18 years or older whose condition is not suitable for treatment using surgery or radiotherapy, and are not expected to respond to existing anticancer drugs, or a standard therapy has not been established. Approximately 50 patients are expected to take part. The number of patients may change depending on the progress of the study.
The scheduled period for the entire clinical trial is March 2015 to December 2016. During the study participants will be expected to undergo a number of procedures including blood tests, physical examinations and scans.REC name
London - Surrey Borders Research Ethics Committee
REC reference
16/LO/0708
Date of REC Opinion
10 Jun 2016
REC opinion
Further Information Favourable Opinion