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Spots Global Cancer Trial Database for DETERMINE Trial Treatment Arm 03: Entrectinib in Adult, Teenage/Young Adults and Paediatric Patients With ROS1 Gene Fusion-positive Cancers.

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Trial Identification

Brief Title: DETERMINE Trial Treatment Arm 03: Entrectinib in Adult, Teenage/Young Adults and Paediatric Patients With ROS1 Gene Fusion-positive Cancers.

Official 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. Treatment Arm 03: Entrectinib in Adult, Teenage/Young Adults and Paediatric Patients With ROS1 Gene Fusion-positive Cancers.

Study ID: NCT05770544

Interventions

Entrectinib

Study Description

Brief Summary: This clinical trial is looking at a drug called entrectinib. 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.

Detailed Description: DETERMINE Treatment Arm 03 (entrectinib) aims to evaluate the efficacy of entrectinib in ROS1 gene fusion-positive rare\* adult, paediatric and teenage/young adult (TYA) cancers and in common cancers where a ROS1 mutation or amplification is considered to be infrequent. \*Rare is defined generally as incidence less than 6 cases in 100,000 patients (includes paediatric and teenagers/young adult cancers) or common cancers with rare alterations. This treatment arm has a target sample size of 30 evaluable patients. Sub-cohorts may be defined and further expanded where promising activity is identified to a target of 30 evaluable patients each. The ultimate aim is to translate positive clinical findings to the NHS (Cancer Drugs Fund) to provide new treatment options for rare adult, paediatric and TYA cancers. OUTLINE: Pre-screening: The Molecular Tumour Board makes a treatment recommendation for the participant based on molecularly-defined cohorts. Screening: Consenting participants undergo biopsy and collection of blood samples for research purposes. Treatment: Participants will receive entrectinib until disease progression, unacceptable toxicity or withdrawal of consent. Participants will also undergo collection of blood samples at various intervals while receiving treatment and at the end of trial visit (EoT). After completion of study treatment, patients are followed up every 3 months for 2 years THE DETERMINE TRIAL MASTER (SCREENING) PROTOCOL: Please see DETERMINE Trial Master (Screening) Protocol record (NCT05722886) for information on the DETERMINE Trial Master Protocol and applicable documents.

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Matthew Krebs, Prof

Affiliation: The Christie Hospital

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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