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

Study acronym: DETERMINE
StatusRecruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Eligibility criteria shortened, about 171 words Study description expanded, about 2 wordsv9 Show 1 more changeShow less
    • Study description expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  2. Start date: May 2025 to Nov 30, 2025v8
  3. Start date: Jun 2024 to May 2025 Study sites: 26 to 27 · Secondary endpoints revised (13) · Study title revised · 2 morev7 Show 5 more changesShow less
    • Study sites: 26 to 27
    • Secondary endpoints revised (13)
    • Study title revised
    • Eligibility criteria shortened, about 2 words
    • Study description shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  4. Start date: Dec 2023 to Jun 2024v6
  5. Site details revised at 6 of 26 sitesv5
Show 3 earlier versionsHide 3 earlier versions
  1. Start date: Jul 2023 to Dec 2023v4
  2. Start date: Apr 2023 to Jul 2023 Eligibility criteria revised · Study description revised · Site details revised at 2 of 26 sites · 1 morev3 Show 4 more changesShow less
    • Eligibility criteria revised
    • Study description revised
    • Site details revised at 2 of 26 sites
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  3. Site details revised at 3 of 26 sitesv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Cancer Research UK
15 trials monitored
See 2 trials at risk
Melanoma
1,026 trials monitored
See 48 trials at risk
Glioma
668 trials monitored
See 40 trials at risk
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.
Trial Details
NCT Number NCT05770544
Lead Sponsor Cancer Research UK
Collaborators: University of Manchester, University of Birmingham, Royal Marsden NHS Foundation Trust, Hoffmann-La Roche
Conditions Haematological Malignancy, Malignancy, Malignant Neoplasm, Lymphoproliferative Disorders, Neoplasms by Histologic Type, Neoplasms by Site, Cancer, Brain Neoplasms +3 more
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov