Open Label study of entrectinib in ROS1 gene fusion-positive rare adult, paediatric and teenage/young adult cancers

Cancer Research UK in collaboration with University of Manchester, University of Birmingham, Royal Marsden NHS Foundation Trust, and Hoffmann-La Roche are commencing recruitment into the clinical trial that is looking at a drug called entrectinib. The researchers plan that the study duration will be from April 2023 till October 2029.

Entrectinib is approved as standard of care treatment for adult patients with non-small cell lung cancer (NSCLC) which have a particular molecular alteration called ROS1-positive, and patients 12 years of age or older with solid tumours which have another type of change in the cancer cells.

This means it has gone through clinical trials and been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Investigators now wish to find out if it will be useful in treating patients with other cancer types which have the same molecular alteration (ROS1-positive).

If the results are positive, the study team will work with the NHS and the Cancer Drugs Fund to see if these drugs can be routinely accessed for patients in the future. This trial is part of a trial programme called DETERMINE. The programme will also look at other anti-cancer drugs in the same way, through matching the drug to rare cancer types or ones with specific mutations.

The study will take place at the several research sites around in the UK:

  • Belfast City Hospital, Belfast, United Kingdom;
  • University Hospital Birmingham, Birmingham, United Kingdom;
  • Birmingham Children's Hospital, Birmingham, United Kingdom;
  • Bristol Royal Hospital for Children, Bristol, United Kingdom;
  • Bristol Haematology and Oncology Centre, Bristol, United Kingdom;
  • Addenbrooke's Hospital, Cambridge, United Kingdom;
  • Velindre Cancer Centre, Cardiff, United Kingdom;
  • Western General Hospital, Edinburgh, United Kingdom;
  • The Beatson Hospital, Glasgow, United Kingdom;
  • Royal Hospital for Children Glasgow, Glasgow, United Kingdom;
  • Leeds General Infirmary, Leeds, United Kingdom;
  • Leicester Royal Infirmary, Leicester, United Kingdom;
  • Alder Hey Hospital, Liverpool, United Kingdom;
  • The Royal Marsden Hospital, London Borough of Sutton, United Kingdom;
  • University College London Hospital, London, United Kingdom;
  • Guy's Hospital, London, United Kingdom;
  • Great Ormond Street Hospital, London, United Kingdom;
  • Royal Manchester Children's Hospital, Manchester, United Kingdom;
  • The Christie Hospital, Manchester, United Kingdom;
  • Great North Children's Hospital, Newcastle, United Kingdom;
  • Freeman Hospital, Newcastle, United Kingdom;
  • Churchill Hospital, Oxford, United Kingdom;
  • John Radcliffe Hospital, Oxford, United Kingdom;
  • Weston Park Hospital, Sheffield, United Kingdom;
  • Southampton General Hospital, Southampton, United Kingdom;
  • Clatterbridge Cancer Centre, Wirral, United Kingdom.

The page dedicated to this clinical trial inclusion and exclusion criteria, as well as th esites' contacts can be found here: https://ichgcp.net/clinical-trials-registry/NCT05770544

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