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DETERMINE (Determining Extended Therapeutic Indications for Existing Drugs in Rare Molecularly Defined Indications Using a National Evaluation Platform Trial) - Master Screening Protocol

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

Record History

  1. Interventions: Alectinib (Drug), Atezolizumab (Drug), Capmatinib (Drug), Entrectinib (Drug), Trastuzumab in combination with pertuzumab (Drug)… to Alectinib (Drug), Atezolizumab (Drug), Capmatinib (Drug), Dabrafenib in combination with trametinib (Drug), Entrectinib (Drug), Trastuzumab… Eligibility criteria expanded, about 14 words · Site details revised at 3 of 27 sites · Study arms: 6 to 7v8 Show 3 more changesShow less
    • Eligibility criteria expanded, about 14 words
    • Site details revised at 3 of 27 sites
    • Study arms: 6 to 7

    See this version in full on ClinicalTrials.gov ↗

  2. Eligibility criteria expanded, about 63 wordsv7 See this version in full on ClinicalTrials.gov ↗
  3. Study sites: 25 to 27 Interventions: Alectinib (Drug), Atezolizumab (Drug), Entrectinib (Drug), Trastuzumab in combination with pertuzumab (Drug), Vemurafenib in combination… to Alectinib (Drug), Atezolizumab (Drug), Capmatinib (Drug), Entrectinib (Drug), Trastuzumab in combination with pertuzumab (Drug)… · Eligibility criteria shortened, about 29 words · Study description shortened, about 10 words · 2 morev6 Show 5 more changesShow less
    • Interventions: Alectinib (Drug), Atezolizumab (Drug), Entrectinib (Drug), Trastuzumab in combination with pertuzumab (Drug), Vemurafenib in combination… to Alectinib (Drug), Atezolizumab (Drug), Capmatinib (Drug), Entrectinib (Drug), Trastuzumab in combination with pertuzumab (Drug)…
    • Eligibility criteria shortened, about 29 words
    • Study description shortened, about 10 words
    • Collaborators: 4 to 5
    • Study arms: 5 to 6

    See this version in full on ClinicalTrials.gov ↗

  4. Study sites: 26 to 25v5
  5. Site details revised at 7 of 26 sitesv4
Show 2 earlier versionsHide 2 earlier versions
  1. Site details revised at 2 of 26 sites Study description expanded, about 3 wordsv3 Show 1 more changeShow less
    • Study description expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  2. Study sites: 25 to 26 Start date changed from estimate of Feb 2023 to Mar 1, 2023v2 Show 1 more changeShow less
    • Start date changed from estimate of Feb 2023 to Mar 1, 2023
  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.
DETERMINE is an open-label phase II/III trial. It will look at targeted treatments in rare cancers or common cancers with rare genetic change (mutation). Patients must have a cancer with an identified mutation. This could be found during routine testing or as part of another research programme. The DETERMINE trial will recruit adults, teenagers and children. If a drug is found to benefit a new patient group, the study team will work with the NHS and the Cancer Drugs Funds to see if these drugs can be available for patients in the future. This clinicaltrials.gov record refers to the Overall Trial Protocol (Master Screening Record), additional records will be added to clinicaltrials.gov for each treatment arm.
Trial Details
NCT Number NCT05722886
Lead Sponsor Cancer Research UK
Collaborators: University of Manchester, University of Birmingham, Royal Marsden NHS Foundation Trust, Hoffmann-La Roche, Novartis Pharmaceuticals
Conditions Haematological Malignancy, Solid Tumour
Enrollment 825 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov