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DETERMINE Trial Treatment Arm 01: Alectinib in Adult, Paediatric and Teenage/Young Adult Patients With ALK Positive Cancers

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

Record History

  1. Minor Eligibility criteria shortened, about 173 words Study description expanded, about 2 wordsv8 Show 1 more changeShow less
    • Study description expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  2. Minor Study sites: 26 to 27 Eligibility criteria expanded, about 33 words · Secondary endpoints: 13 to 12 · Study description shortened, about 2 words · 1 morev7 Show 4 more changesShow less
    • Eligibility criteria expanded, about 33 words
    • Secondary endpoints: 13 to 12
    • Study description shortened, about 2 words
    • Study title shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  3. Minor Start date changed from estimate of Oct 2023 to Dec 18, 2023v6
  4. Minor Site details revised at 7 of 26 sitesv5
  5. Notable Start date: Jul 2023 to Oct 2023v4
Show 2 earlier versionsHide 2 earlier versions
  1. Notable 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 ↗

  2. Minor Site details revised at 3 of 26 sitesv2
  1. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This clinical trial is looking at a drug called alectinib. Alectinib is approved as standard of care treatment for adult patients with certain types of lung cancer. This means it has gone through clinical trials and been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Alectinib works in lung cancer patients with a particular mutation in their cancer known as ALK. Investigators now wish to find out if it will be useful in treating patients with other cancer types which have the same mutation. 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 NCT05770037
Lead Sponsor Cancer Research UK
Collaborators: University of Manchester, University of Birmingham, Royal Marsden NHS Foundation Trust, Hoffmann-La Roche
Conditions Haematological Malignancy, Malignant Neoplasm, Lymphoproliferative Disorders, Neoplasms by Histologic Type, Neoplasms by Site, Cancer, Anaplastic Large Cell Lymphoma, Lymphoma +3 more
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov