ONO-7579-01, open-label, 2 part study in advanced solid tumours
Research type
Research Study
Full title
An open-label, multi-center, dose-escalation and expansion study to evaluate the safety and efficacy of ONO-7579 in patients with advanced solid tumors/ NTRK gene fusion positive advanced solid tumors
IRAS ID
228218
Contact name
Jeff Evans
Contact email
Sponsor organisation
ONO Pharma UK Ltd
Eudract number
2016-004987-21
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 3 months, 9 days
Research summary
This study is a first in human study of increasing doses of a new anti-cancer drug to determine the safety and anti-tumour effectiveness of ONO-7579 in patients with advanced solid tumours. Both the researchers and the patient will know what medication the patient is receiving, and the study will take place at more than one hospital.
There are 2 parts to the study; A and B. Part A will determine the safety and tolerability of ONO-7579 and determine the MTD (maximum tolerated dose)/ RCD (recommended clinical dose). The MTD/ RCD is the highest dose of the study drug that can be used safely and doesn’t cause unacceptable side effects. This will help to identify the appropriate dose to use in Part B of the study. Part B will\nevaluate the safety and effectiveness of ONO-7579 in cancer patients with NTRK (Neurotrophic tropomyosin receptor kinase – a protein coding gene) gene fusions. Dose-escalation is the process\nthat will be followed in Part A from the lowest dose, of 3 mg once a day, until the maximum expected dose, of 300 mg once a day, is reached. Expansion is the process that will be followed in Part B to assess the maximum tolerated dose (MTD), that was identified in Part A, in a greater number of patients.
The study drug is designed to slow or stop the action of a specific protein in the body, called a tropomyosin receptor kinase (Trk). This protein is involved in several processes in the body, like cell growth, survival, and the process by which a cell becomes specialised in order to perform a specific function within the body e.g. blood cell or nerve. Stopping the action of this protein is thought to slow down some of the cell processes that cause cancer cells to grow and multiply.\n\nIn Part A (Dose-Escalation Phase), approximately 30 patients will participate. 9 out of these 30 patients will be recruited to determine the effect of food on PK of ONO-7579. In Part B (Expansion Phase),initially approximately 10 patients will be enrolled, with further recruitment expanded up to approximately 35 patients if there is a positive risk benefit indicated.
REC name
West of Scotland REC 1
REC reference
17/WS/0160
Date of REC Opinion
13 Sep 2017
REC opinion
Further Information Favourable Opinion