A Phase I trial of LY3143921 hydrate in solid tumours
Research type
Research Study
Full title
A Cancer Research UK phase I trial of LY3143921 hydrate (a Cdc7 inhibitor) given orally once daily in adult patients with advanced solid tumours
IRAS ID
216105
Contact name
Richard Wilson
Contact email
Sponsor organisation
Cancer Research UK, Centre for Drug Development
Eudract number
2016-001245-80
Duration of Study in the UK
3 years, 5 months, 30 days
Research summary
This clinical study is looking at a drug called LY3143921 hydrate (a Cdc7 inhibitor) in adult patients with advanced solid tumours.
This clinical study has two parts:
Part 1 - a ‘dose escalation’ phase where groups of patients will receive increasing doses of LY3143921 hydrate to find a safe dose and a dose that best targets the cancer cells.
Part 2 - an ‘expansion’ phase where a larger group of patients will receive the highest dose of LY3143921 hydrate considered to be safe from Part 1, to find out more about how the drug is working.The main aims of this clinical study are to find out the maximum dose that can be given safely to patients, more about the potential side effects of LY3143921 hydrate and how they can be treated, what happens to LY3143921 hydrate inside the body and how the drug affects cancer cells in the body. This information will help us decide how much and how often to give LY3143921 hydrate to patients in future studies.
The study will be conducted at a number of NHS sites across the UK and will recruit between 23 and 68 adult patients depending on the number of doses which are explored in the dose escalation phase.
REC name
HSC REC A
REC reference
17/NI/0005
Date of REC Opinion
15 Feb 2017
REC opinion
Further Information Favourable Opinion