At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Entrectinib (drug)
- How long the study runs
- Study runs about 47 months (dates as stated)
- About the drug or intervention
- Entrectinib — drug: Adult and paediatric patients with body surface area (BSA) ≥1.51 m\^2 will receive entrectinib orally at a dose of 600 mg daily dose (three 200 mg capsules per day).
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- Not specified
- Who
- All
- Number of participants
- 30
- Started
- 2025-11-30
- Last checked
- 2025-11
Plain English Summary
What is this study?
- • Testing a new treatment for haematological malignancy
- • Phase2/Phase3 - 30 participants
- • This clinical trial is looking at a drug called entrectinib
Who can take part?
- • Adults
- • Diagnosed with haematological malignancy
Where?
- • Belfast - Belfast City Hospital
- • Birmingham - University Hospital Birmingham
- • Birmingham - Birmingham Children's Hospital
- • Bristol - Bristol Royal Hospital for Children
- • +23 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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 old or above 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.
More detail
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 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 patient based on molecularly-defined cohorts. Screening: Consenting patients undergo biopsy and collection of blood samples for research purposes. Treatment: Patients will receive entrectinib until disease progression without clinical benefit, unacceptable adverse events (AEs) or withdrawal of consent. Patients will also undergo collection of blood samples at various intervals while receiving treatment and at the end of treatment 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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: Not specified
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓A. Confirmed diagnosis of a ROS1 gene fusion-positive cancer, other than NSCLC, that has been identified using...
- ✓C. Patients with a BSA of 0.43m\^2 and over.
- ✓F. Women of childbearing potential are eligible provided that they meet the following criteria:
- ✓Have a negative serum or urine pregnancy test before enrolment and either:
- ✓Agree to use one form of highly effective birth control method such as:
Who cannot take part
- ✗A. Female patients who are pregnant, breastfeeding or planning to become pregnant during the trial or within five...
- ✗B. Diagnosis of ROS1 fusion-positive NSCLC
- ✗C. Prior treatment with the same class of drug unless genetic profile demonstrates a mechanism of resistance known...
- ✗D. Patients with significant cardiovascular disease are excluded as defined by:
- ✗i. Current congestive heart failure requiring therapy (New York Heart Association III or IV) or known left...
See the full criteria
Where Is This Study? (27 UK sites)
Belfast City Hospital
Belfast BT9 7AB, United Kingdom
University Hospital Birmingham
Birmingham B15 2TT, United Kingdom
Birmingham Children's Hospital
Birmingham, United Kingdom
Bristol Royal Hospital for Children
Bristol BS2 8BJ, United Kingdom
Bristol Haematology and Oncology Centre
Bristol BS2 8ED, United Kingdom
Addenbrooke's Hospital
Cambridge CB2 OQQ, United Kingdom
Velindre Cancer Centre
Cardiff CF14 2TL, United Kingdom
Cardiff Children's Hospital
Cardiff CF14 4XW, United Kingdom
Western General Hospital
Edinburgh EH4 2XU, United Kingdom
The Beatson Hospital
Glasgow G12 OYN, United Kingdom
Royal Hospital for Children Glasgow
Glasgow G51 4TF, United Kingdom
Leicester Royal Infirmary
Leicester LE1 5WW, United Kingdom
Alder Hey Hospital
Liverpool L14 5AB, United Kingdom
University College London Hospital
London NW1 2BU, United Kingdom
Guy's Hospital
London SE1 9RT, United Kingdom
Great Ormond Street Hospital
London WC1N 3JH, United Kingdom
Royal Manchester Children's Hospital
Manchester M13 9WL, United Kingdom
The Christie Hospital
Manchester M20 4BX, United Kingdom
Clatterbridge Cancer Centre
Metropolitan Borough of Wirral CH63 4JY, United Kingdom
Great North Children's Hospital
Newcastle NE1 4LP, United Kingdom
Freeman Hospital
Newcastle NE7 7DN, United Kingdom
Churchill Hospital
Oxford OX3 7LE, United Kingdom
John Radcliffe Hospital
Oxford OX3 9DU, United Kingdom
Weston Park Hospital
Sheffield S10 2SJ, United Kingdom
Sheffield's Children's Hospital
Sheffield S10 2TH, United Kingdom
Southampton General Hospital
Southampton SO16 6YD, United Kingdom
The Royal Marsden Hospital
Sutton SM2 5PT, United Kingdom
How to Get in Touch
Aida Sarmiento Castro
Sponsor contactCONTACT
