DETERMINE
Research type
Research Study
Full title
DETERMINE (Determining Extended Therapeutic indications for Existing drugs in Rare Molecularly defined Indications using a National Evaluation platform trial): An Umbrella-Basket Platform Trial to Evaluate the Efficacy of Targeted Therapies in Rare Adult, Paediatric and Teenage/Young Adult (TYA) Cancers with Actionable Genomic Alterations, including Common Cancers with Rare Actionable Alterations.
IRAS ID
1004057
Contact name
Paige Neal
Contact email
Sponsor organisation
Cancer Research UK
Eudract number
2021-003391-14
Clinicaltrials.gov Identifier
Research summary
The DETERMINE trial is a 5 year study (with 2 year follow up) which will enable patients with rare cancers to access targeted licensed (approved for patient use) therapies outside of their licence, where they have the specific genetic mutation that particular drug targets. The trial aims to have a number of different treatment options available (~20) for patients who are eligible to be enrolled onto the study. This will provide access to potentially beneficial drugs to a group of patients who would otherwise have run out of treatment options and includes adults, teenagers and children with rare cancers. ‘Rare’ is defined generally as incidence less than 6 cases in 100,000 patients (includes paediatric and teenager and young adult cancers) or common cancers with rare alterations. If a particular drug is found to benefit a new patient group the study team will work with regulatory agencies and NHS England to explore how these drugs can be accessed routinely for patients in the future. To take part in the trial, patients will be referred to one of the participating trial sites around the UK that have expertise in cancer trials if they are identified to have a genetic alteration in their cancer (performed from routine genetic testing or as part of another research program). Patients will be asked to provide written consent and be monitored closely whilst on trial both for side effects and to see whether the drug is successfully treating the cancer. Patients will be fully informed of all trial procedures before they are asked if they would like to consent. Tumour and blood samples will be collected from patients on this trial so scientists can look closely at the cells of different patients to understand which factors contribute to differences in patient benefit.
REC name
London - City & East Research Ethics Committee
REC reference
22/LO/0330
Date of REC Opinion
28 Jun 2022
REC opinion
Further Information Favourable Opinion