PATRIOT
Research type
Research Study
Full title
A Phase I Study to assess the Tolerability, Safety and Biological Effects of a Specific Ataxia Telangiectasia and Rad3-Related (ATR) Inhibitor (AZD6738) as a Single Agent and in Combination with Palliative Radiation Therapy in Patients with Solid Tumours
IRAS ID
140396
Contact name
Kevin Harrington
Contact email
Sponsor organisation
Royal Marsden NHS Foundation Trust
Eudract number
2013-003994-84
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
This study will investigate the use of a new drug targeting the DNA repair pathway (AZD6738, an ATR inhibitor). Many tumours have lost important DNA repair functions and rely more heavily on a few remaining repair pathways to survive. Pre-clinical studies indicate that, in these tumours, preventing the function of the remaining pathways will lead to tumour cell death, while sparing normal cells. This study aims to investigate the safety and tolerability of the new drug in patients with advanced cancer, as well as in combination with palliative radiotherapy, where the drug may increase the effectiveness of radiotherapy by preventing repair of the radiation-induced DNA damage. As the drug has only been given to a small number of patients, the study will focus on safety and finding the correct dose to proceed to further studies, although preliminary signs of drug activity will also be examined.
The initial part of the study will administer increasing doses of the drug to groups of patients with advanced cancer who have no standard anti-cancer treatment options available. Testing will establish whether the drug levels in the body and tumour are adequate for the drug to have an effect, and any toxicity will be assessed. After the recommended dose is established, the recommended dose schedule will be established by trialing different schedules. Participants will be tested to see if their tumours lack the main DNA repair pathway (those who are predicted to have a better response to this drug). Finally, the drug will be given to patients with advanced cancer who require a course of radiotherapy for symptom control – the drug will be tested at different doses and with different doses of radiotherapy. Side effects will be monitored and tests will establish whether the drug is enhancing the radiotherapy effect in the tumours or normal tissues.REC name
London - City & East Research Ethics Committee
REC reference
14/LO/0465
Date of REC Opinion
16 May 2014
REC opinion
Further Information Favourable Opinion