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Haematological MalignancyPhase 2/3DETERMINENCT05770544

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

A Phase 2/3 study testing Entrectinib in people with Haematological Malignancy and Malignancy, run by Cancer Research UK at 27 sites in United Kingdom.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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 old or above with solid tumours which have another type… Read more about this study

Who is it for?
Any age
What is being tested?
Entrectinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
27 sitesUnited Kingdom
Study dates
30 Nov 2025to Oct 2029
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Confirmed diagnosis of a ROS1 gene fusion-positive malignancy, other than NSCLC, that has been identified using an analytically validated next-generation sequencing method.
  • Patients must be able and willing to undergo a fresh tissue biopsy at baseline and blood samples for translational research. Note that for patients with haematological malignancies or neuroblastomas, blood, bone marrow aspiration and/or trephine or lymph node biopsy samples may be taken.
  • Patients with a BSA of 0.43m^2 and over.
  • ADULT PATIENTS (≥18 years): Adequate organ function as per haematological and biochemical indices within the ranges defined in the protocol. These measurements should be performed to confirm the patient's eligibility.
  • PAEDIATRIC PATIENTS (<18 years): Adequate organ function as per haematological and biochemical indices within the ranges defined in the protocol. These measurements should be performed to confirm the patient's eligibility.
  • Women of childbearing potential are eligible provided that they meet the following criteria:
Show all 22Show fewer
  • 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:
  • Oral, intravaginal or transdermal combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation
  • Oral, injectable or implantable progestogen-only hormonal contraception associated with inhibition of ovulation
  • Intrauterine device (IUD)
  • Intrauterine hormone-releasing system (IUS)
  • Bilateral tubal occlusion
  • Vasectomised partner
  • Plus a barrier method if using a hormonal method: male or female condom with or without spermicide; cap, diaphragm or sponge with spermicide OR
  • Sexual abstinence;
  • Effective from the first administration of entrectinib, throughout the trial and for five weeks after the last administration of entrectinib.
  • Male patients with partners who are women of childbearing potential are eligible provided that they agree to the following, from the first administration of entrectinib, throughout the trial and for three months after the last administration of entrectinib:
  • Agree to take measures not to father children by using a barrier method of contraception (condom plus spermicide) or to sexual abstinence.
  • Non-vasectomised male patients with partners who are women of childbearing potential must also be willing to ensure that their partner uses a highly effective method of contraception as in F above.
  • Male patients with pregnant or lactating partners must be advised to use barrier method contraception (e.g. condom) to prevent drug exposure of the foetus or neonate.
  • All male patients must refrain from donating sperm for the same period.

Who cannot join

  • Female patients who are pregnant, breastfeeding or planning to become pregnant during the trial or within five weeks following their last dose of entrectinib
  • Diagnosis of ROS1 fusion-positive NSCLC
  • Prior treatment with the same class of drug unless genetic profile demonstrates a mechanism of resistance known to be potentially sensitive to entrectinib
  • Patients with significant cardiovascular disease are excluded as defined by:
  • Current congestive heart failure requiring therapy (New York Heart Association III or IV) or known left ventricular ejection fraction (LVEF) <50% (moderate to severe).
  • History of unstable angina pectoris or myocardial infarction up to three months prior to trial entry, or current poorly controlled angina (symptoms weekly or more).
Show all 23Show fewer
  • Presence of symptomatic or severe valvular heart disease (severe by local echo graphic criteria or American Heart Association/American Cardiac College Stage C or D).
  • History of a clinically significant cardiac arrhythmia up to three months prior to trial entry (asymptomatic atrial fibrillation or asymptomatic first-degree heart block are permitted.
  • History of stroke (ischaemic or haemorrhagic) within the last three months.
  • Patients with primary CNS tumours may be considered unless intra-tumoural bleeding has occurred within 2 weeks of the first dose of entrectinib, and patients with punctate CNS haemorrhages <3 mm may be considered.
  • Patients with a baseline QTcF (Corrected QT interval by Fridericia formula) interval longer than 450 milliseconds (ms) for male patients and 470 ms for female patients, patients with congenital long QTcF syndrome, and patients taking medicinal products that are known to prolong the QTc interval.
  • History of additional risk factors for Torsades de Pointes (e.g., family history of long QT syndrome)
  • Grade ≥2 peripheral neuropathy
  • Known active infections (bacterial, fungal or viral) that would interfere with the assessment of safety or efficacy of entrectinib, including human immunodeficiency virus (HIV) positivity. Patients with history of testing positive for HIV infection are eligible provided the each of the following conditions are met:
  • CD4 count ≥350/μL;
  • undetectable viral load;
  • receiving antiretroviral therapy (ART) that does not interact with IMP (patients should be on established ART for at least four weeks); and
  • no HIV/ acquired immune deficiency syndrome (AIDS)-associated opportunistic infection in the last 12 months.
  • Known hypersensitivity to entrectinib or any of the excipients
  • Patients who were administered a live, attenuated vaccine within 28 days prior to enrolment, or anticipation of need for such a vaccine during entrectinib treatment or within six months after the final dose of entrectinib
  • Patient unable to swallow entrectinib intact, without chewing, crushing or opening the capsules (as per the dosing schedule and suitable dosing strengths available). Any active gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would reasonably affect drug absorption
  • Patients with personal history of significant osteopenia (screening for osteopenia not required)
  • Any clinically significant concomitant disease or condition (or its treatment) that could interfere with the conduct of the trial or absorption of oral medications that would, in the opinion of the Investigator, pose an unacceptable risk to the patient in this trial

Trial locations and contacts

27 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Aida Sarmiento Castro contact

+44 207 242 0200

determine@cancer.org.uk

27 sites in 1 country

United Kingdom27 sites, 27 recruiting

  • Belfast City Hospital

    Belfast, BT9 7AB

    Vicky Coyle, Prof, V.Coyle@qub.ac.uk

    Vicky Coyle, Prof

    Recruiting

  • University Hospital Birmingham

    Birmingham, B15 2TT

    Gary Middleton, Prof, 0121 371 3573, G.Middleton@bham.ac.uk

    Gary Middleton, Prof

    Recruiting

  • Birmingham Children's Hospital

    Birmingham

    Gerard Millen, Dr, 07921843607, g.millen@nhs.net

    Gerard Millen, Dr

    Not yet recruiting

  • Bristol Royal Hospital for Children

    Bristol, BS2 8BJ

    Antony Ng, Dr, 0117 342 8044, Antony.Ng@uhbw.nhs.uk

    Antony Ng, Dr

    Recruiting

  • Bristol Haematology and Oncology Centre

    Bristol, BS2 8ED

    Antony Ng, Dr, 0117 342 8044, Antony.Ng@uhbw.nhs.uk

    Antony Ng, Dr

    Recruiting

  • Addenbrooke's Hospital

    Cambridge, CB2 OQQ

    Bristi Basu, Dr, 01223 596105, bb313@medschl.cam.ac.uk

    Bristi Basu, Dr

    Recruiting

  • Velindre Cancer Centre

    Cardiff, CF14 2TL

    Robert Jones, Dr, 02920 615888 ext. 6327, Robert.Hugh.Jones@wales.nhs.uk

    Robert Jones, Dr

    Recruiting

  • Cardiff Children's Hospital

    Cardiff, CF14 4XW

    Madeline Adams, Dr, +442921842285, madeline.adams@wales.nhs.uk

    Madeline Adams, Dr

    Not yet recruiting

  • Western General Hospital

    Edinburgh, EH4 2XU

    Stefan Symeonides, Dr

    Stefan Symeonides, Dr

    Recruiting

  • The Beatson Hospital

    Glasgow, G12 OYN

    Patricia Roxburgh, Dr, 0141 301 7118, Patricia.Roxburgh@glasgow.ac.uk

    Patricia Roxburgh, Dr

    Recruiting

  • Royal Hospital for Children Glasgow

    Glasgow, G51 4TF

    Milind Ronghe, Dr, 0141 452 6692, Milind.Ronghe@ggc.scot.nhs.uk

    Milind Ronghe, Dr

    Recruiting

  • Leicester Royal Infirmary

    Leicester, LE1 5WW

    Olubukola Ayodele, Dr, 0116 2587601, olubukola.ayodele@uhl-tr.nhs.uk

    Olubukola Ayodele, Dr

    Recruiting

  • Alder Hey Hospital

    Liverpool, L14 5AB

    Lisa Howell, Dr, 0151 293 3679, Lisa.Howell@alderhey.nhs.uk

    Lisa Howell, Dr

    Recruiting

  • University College London Hospital

    London, NW1 2BU

    Martin Forster, Prof, 020 3447 5085, M.Forster@ucl.ac.uk

    Martin Forster, Prof

    Recruiting

  • Guy's Hospital

    London, SE1 9RT

    James Spicer, Dr, 020 7188 4260, james.spicer@kcl.ac.uk

    James Spicer, Dr

    Recruiting

  • Great Ormond Street Hospital

    London, WC1N 3JH

    Darren Hargrave, Dr, 0207 813 8525, Darren.hargrave@gosh.nhs.uk

    Darren Hargrave, Dr

    Recruiting

  • Royal Manchester Children's Hospital

    Manchester, M13 9WL

    Guy Makin, Dr, 0161 701 8419, Guy.Makin@mft.nhs.uk

    Guy Makin, Dr

    Not yet recruiting

  • The Christie Hospital

    Manchester, M20 4BX

    Matthew Krebs, Dr, 0161 918 7672, matthew.krebs@nhs.net

    Matthew Krebs, Dr

    Recruiting

  • Clatterbridge Cancer Centre

    Metropolitan Borough of Wirral, CH63 4JY

    Dan Palmer, Dr, 0151 706 4172 / 0151 706 4177, daniel.palmer@liverpool.ac.uk

    Dan Palmer, Dr

    Recruiting

  • Great North Children's Hospital

    Newcastle, NE1 4LP

    Alastair Greystoke, Dr, 0191 2138476, Alastair.Greystoke@newcastle.ac.uk

    Alastair Greystoke, Dr

    Recruiting

  • Freeman Hospital

    Newcastle, NE7 7DN

    Alastair Greystoke, Dr, 0191 2138476, Greystoke@newcastle.ac.uk

    Alastair Greystoke, Dr

    Recruiting

  • Churchill Hospital

    Oxford, OX3 7LE

    Sarah Pratap, Dr, 01865 235273, Sarah.Pratap@ouh.nhs.uk

    Sarah Pratap, Dr

    Recruiting

  • John Radcliffe Hospital

    Oxford, OX3 9DU

    Sarah Pratap, Dr, 01865 235273, Sarah.Pratap@ouh.nhs.uk

    Sarah Pratap, Dr

    Recruiting

  • Weston Park Hospital

    Sheffield, S10 2SJ

    Sarah Danson, Dr, 0114 226 5068, s.danson@sheffield.ac.uk

    Sarah Danson, Dr

    Recruiting

  • Sheffield's Children's Hospital

    Sheffield, S10 2TH

    Daniel Yeomanson, Dr, 01142717366, danyeomanson@nhs.net

    Daniel Yeomanson, Dr

    Recruiting

  • Southampton General Hospital

    Southampton, SO16 6YD

    Juliet Gray, Prof, 0238 120 6639, Juliet.Gray@uhs.nhs.uk

    Juliet Gray, Prof

    Recruiting

  • The Royal Marsden Hospital

    Sutton, SM2 5PT

    Lynley Marshall, Dr, 0208 661 3678, LynleyVanessa.Marshall@icr.ac.uk

    Lynley Marshall, Dr

    Recruiting

Other trials in United Kingdom

About this study

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, Paediatric and Teenage/Young Adult Patients With ROS1 Gene Fusion-Positive Cancers.

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.

Read the 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 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.

Being tested
Entrectinib
Keywords
Adult, Antineoplastic Agents, Cancer, Child, Entrectinib, Malignancy, Malignant Neoplasms, Molecular Targeted Therapy, Mutation, Neoplasms by Histologic Site, Neoplasms by Site, Oncogene, Paediatric, Protein Kinase Inhibitors, Rare, ROS1 Protein, human, Tumour-agnostic, Young adult
Medical subject headings
Hematologic Neoplasms, Neoplasms, Lymphoproliferative Disorders, Neoplasms by Histologic Type, Neoplasms by Site, Brain Neoplasms, Melanoma, Glioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EntrectinibDrug

    Also called Rozlytrek

    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).

    Paediatric patients with BSA <1.51 m^2 will receive entrectinib at a dose of 100 mg (BSA=0.43-0.50 m^2) or 200 mg (BSA=0.51-0.80 m^2) or 300 mg (BSA=0.81-1.10 m^2) or 400 mg (BSA=1.11-1.50 m^2).

    Each cycle of treatment will consist of 28 days and patients may continue until disease progression without clinical benefit, unacceptable AEs or withdrawal of consent.

Study groups in NCT05770544
Study groupRoleWhat they receive
Treatment Arm 03ExperimentalThis entrectinib treatment arm is for adult, paediatric and TYA patients with ROS1 gene fusion-positive malignancies.
Receives: Drug: Entrectinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response (OR)

    An OR is defined as the confirmed occurrence of either a Complete Response (CR) or Partial Response (PR) according to Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1 criteria (or immune related [ir]-RECIST or standard imaging criteria for specific disease e.g. Response Evaluation in Neuro Oncology criteria [RANO]). In patients with leukaemia, OR will be defined as the occurrence of CR, CRi (CR with incomplete neutrophil recovery) or CRp (CR with incomplete platelet recovery). The trial will report the proportion of patients with an OR and 95% credible interval.

    Measured: Disease assessments to be performed up to 24 weeks from the start of trial treatment.

  2. Durable Clinical Benefit (DCB)

    DCB is defined as the absence of disease progression for at least 24 weeks from the start of trial treatment according to RECIST Version 1.1 criteria (or ir-RECIST or standard imaging criteria for specific disease e.g. RANO criteria) and, where relevant (e.g. for haematological malignancies), by standard bone marrow response assessment criteria. Alternative definitions of DCB based on different time points may be pre-specified for particular sub-cohorts if 24 weeks is not clinically relevant. The trial will report the proportion of patients with a DCB and 95% credible interval.

    Measured: Disease assessments to be performed up to 24 weeks from the start of trial treatment.

Secondary outcomes (13)

  1. Duration of response (DR)

    DR is defined as the time from the date of the first confirmed CR or PR according to RECIST 1.1 (or ir-RECIST or standard imaging criteria for specific disease e.g. RANO criteria) to the date of disease progression. The trial will report the median DR and 95% credible interval.

    Measured: Disease assessment every 2 cycles of entrectinib (each cycle is 28 days) and at EoT. After 24 weeks, it can be done every 12 weeks, on discussion with Sponsor. Follow-up visits are every 3 months after last dose of entrectinib for up to 2 years.

  2. Best percentage change in sum of target lesion / index lesion diameters (PCSD)

    PCSD is defined as the greatest decrease or least increase in the sum of target lesion diameters (RECIST) or index lesion diameters (irRECIST) as a percentage compared to the baseline measurement. The trial will report the mean PCSD and 95% credible interval.

    Measured: Disease assessment every 2 cycles of entrectinib (each cycle is 28 days) and at EoT. After 24 weeks, it can be done every 12 weeks, on discussion with Sponsor. Follow-up visits are every 3 months after last dose of entrectinib for up to 2 years.

  3. Time to treatment discontinuation (TTD)

    TTD is defined as the time from date of starting trial treatment to date of discontinuing trial treatment, in days estimated by the median of the posterior inverse gamma probability distribution. The trial will report the median TTD and 95% credible interval.

    Measured: From first dose of entrectinib to discontinuation of trial treatment up to 5 years.

  4. Progression-Free Survival time (PFS)

    PFS is defined as the time from date of starting trial treatment to date of progression or date of death without a previous progression recorded estimated by the median of the posterior inverse gamma probability distribution.

    Measured: Disease assessment every 2 cycles of entrectinib (each cycle is 28 days) and at EoT. After 24 weeks, it can be done every 12 weeks, on discussion with Sponsor. Follow-up visits are every 3 months after last dose of entrectinib for up to 2 years.

  5. Time to Progression (TTP)

    TTP is defined as the time from date of starting trial treatment to date of progression or date of death without recorded progression censored rather than events. The trial will report the median TTP and 95% credible interval.

    Measured: Disease assessment every 2 cycles of entrectinib (each cycle is 28 days) and at EoT. After 24 weeks, it can be done every 12 weeks, on discussion with Sponsor. Follow-up visits are every 3 months after last dose of entrectinib for up to 2 years.

  6. Growth Modulation Index (GMI)

    GMI is defined as the ratio of TTP with the trial protocol treatment to TTP on the most recent prior line of therapy. The trial will report the mean GMI and 95% credible interval.

    Measured: Disease assessment every 2 cycles of entrectinib (each cycle is 28 days) and at EoT. After 24 weeks, it can be done every 12 weeks, on discussion with Sponsor. Follow-up visits are every 3 months after last dose of entrectinib for up to 2 years.

  7. Overall Survival time (OS)

    OS is defined as the time from date of starting trial treatment to date of death from any cause estimated by the median of the posterior normal probability distribution.

    Measured: Time of death or up to 2 years after the EoT visit.

  8. Occurrence of at least one Suspected Unexpected Serious Adverse Reaction (SUSAR)

    The trial will report the number of patients who experience at least one SUSAR to entrectinib.

    Measured: From the time of consent until 28 days after last dose of entrectinib (up to 5 years) or until patient starts another anti-cancer therapy, whichever came first. An average time frame will be presented with results entry.

  9. Occurrence of at least one Grade 3, 4 or 5 entrectinib related AE

    Number of patients who experience at least one entrectinib related Grade 3, 4 or 5 AE according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0.

    Measured: From the time of consent until 28 days after last dose of entrectinib (up to 5 years) or until patient starts another anti-cancer therapy, whichever came first. An average time frame will be presented with results entry.

  10. EORTC-QLQ-C30 Standardised Area Under Summary Score Curve (QLQSAUC) in adult patients.

    For adult populations, multiple measures of Quality of Life (QoL) will be generated from patient completion of the European Organisation for Research and Treatment of Cancer QLQ-C30 (EORTC-QLQ-C30) questionnaire (15 measures). For each patient the Summary Score from the questionnaire will be generated at each time point and the area under the curve generated by these scores over time will be calculated and standardised by the time frame. The trial will report the mean QLQSAUC and 95% credible interval.

    Measured: QoL surveys performed prior to inclusion, every cycle (each cycle is 28 days) and at EoT visit (up to 5 years).

  11. EQ-5D Standardised Area Under Index Value Curve (EQ5DSAUC) in adult patients

    For adult populations, two measures of QoL will be generated from patient completion of the EQ-5D-5L questionnaire. For each measure, scores based on responses from the questionnaire will be generated at each time point and the area under the curve generated by these scores over time will be calculated and standardised by the time frame. The trial will report the mean EQ5DSAUC and 95% credible interval.

    Measured: QoL surveys performed prior to inclusion, every cycle (each cycle is 28 days) and at EoT visit (up to 5 years).

  12. Mean change from baseline in the PedsQL 4.0 Standardised Area Under total Scale Score Curve (PedsSAUC) in paediatric patients

    For paediatric populations multiple measures of QoL will be generated from patient completion of the PedsQL 4.0 (4 measures and a Total Scale Score). The Summary Score from the questionnaire will be generated at each time point and the area under the curve generated by these scores over time will be calculated and standardised by the time frame. The trial will report the mean PedsSAUC and 95% credible interval.

    Measured: QoL surveys performed prior to inclusion, every cycle (each cycle is 28 days) and at EoT visit (up to 5 years).

  13. Mean change from baseline in the PedsQL 4.0 Standardised Area Under total Scale Score Curve (PedsSAUC) in parents of paediatric patients

    For paediatric populations multiple measures of QoL will be generated from patient's parent completion of the PedsQL 4.0 (4 measures). The Summary Score from the questionnaire will be generated at each time point and the area under the curve generated by these scores over time will be calculated and standardised by the time frame. The trial will report the mean PedsSAUC and 95% credible interval.

    Measured: QoL surveys performed prior to inclusion, every cycle (each cycle is 28 days) and at EoT visit (up to 5 years).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2023
  2. Study start30 Nov 2025 (estimated)
  3. Primary completionOct 2029 (estimated)
  4. Study completionOct 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05770544
Sponsor's protocol ID
CRUKD/21/004 - Treatment Arm 3
Other IDs
IRAS ID: 1004057
Acronym
DETERMINE
Status last verified
Nov 2025
First submitted
22 Feb 2023
Last updated
24 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual de-identified patient data will be shared with researchers whose proposed use of the data is approved by a review committee of the Sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Entrectinib in people with Haematological Malignancy and Malignancy, run by Cancer Research UK at 27 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Aida Sarmiento Castro (+44 207 242 0200, determine@cancer.org.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response (OR) (time frame: Disease assessments to be performed up to 24 weeks from the start of trial treatment.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05770544.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.

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