Advanced solid tumours Phase 1 safety & tolerability study U3-1784
Research type
Research Study
Full title
A Phase 1, Open-Label, Two-Part, Safety and Tolerability Study of U3-1784 in Patients with Advanced Solid Tumours
IRAS ID
191513
Contact name
Robert Blakie
Contact email
Sponsor organisation
Daiichi Sankyo Development Ltd
Eudract number
2015-002670-20
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
This study is a research project for collecting information about the safety and effectiveness of U3-1784 which is a new medication being developed for the treatment of advanced cancer for patients that have received all standard treatments, no standard treatment is available to treat the cancer or they have chosen not to receive standard treatments. This is a two part study: the main purpose of Part 1 is to establish a safe dose of study drug by gathering information on how well it is tolerated, any potential side effects it may cause and collecting data about how the cancer responds to the study drug. The study will measure the levels of U3-1784 in the blood and the action of U3-1784 in the body over a period of time, and whether the study drug has an effect on this type of cancer. Part 2 is to assess how safe the maximum dose from Part 1 is in participants with advanced hepatocellular cancer and how well that dose is tolerated. It is hoped that this study drug may stop or reduce cancer growth.
REC name
North East - York Research Ethics Committee
REC reference
15/NE/0375
Date of REC Opinion
30 Nov 2015
REC opinion
Further Information Favourable Opinion