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Personalized Medicine for Advanced Biliary Cancer Patients

Study acronym: SAFIR-ABC10
StatusRecruiting
PhasePhase 3
SponsorUNICANCER
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv12
  2. Study sites: 72 to 69v11
  3. Site details revised at 6 of 72 sitesv10
  4. Site details revised at 7 of 72 sitesv9
  5. Start date: May 29, 2024 to Jul 18, 2024 Study sites: 74 to 72v8 Show 1 more changeShow less
    • Study sites: 74 to 72
Show 6 earlier versionsHide 6 earlier versions
  1. Site details revised at 2 of 74 sitesv7
  2. Trial status: Not Yet Recruiting to Recruiting Study sites: 57 to 74 · Start date changed from estimate of Apr 2024 to May 29, 2024 · Eligibility criteria expanded, about 66 words · 1 morev6 Show 4 more changesShow less
    • Study sites: 57 to 74
    • Start date changed from estimate of Apr 2024 to May 29, 2024
    • Eligibility criteria expanded, about 66 words
    • Collaborators: 10 to 9

    See this version in full on ClinicalTrials.gov ↗

  3. Start date: Jan 2024 to Apr 2024v5
  4. Start date: Oct 2023 to Jan 2024v4
  5. Start date: Jun 2023 to Oct 2023v3
  6. Start date: Feb 2023 to Jun 2023v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
UNICANCER
98 trials monitored
See 7 trials at risk
Cholangiocarcinoma
614 trials monitored
See 23 trials at risk
The object of this trial is to evaluate whether the introduction of a targeted therapy after 4 cycles of the current standard-of-care treatment for advanced biliary cancer is superior to continuing with the standard treatment. The trial is composed of two phases: (i) An initial screening phase to identify a suitable patient population, during which a molecular profile of the patient's tumour will be obtained, and (ii) a randomised comparative trial in which patients with disease control after 4 cycles of standard treatment, and whose tumour harbours a targetable molecular alteration, will be randomised (2:1) to receive either a matched targeted therapy or to continue with the standard treatment.
Trial Details
NCT Number NCT05615818
Lead Sponsor UNICANCER
Collaborators: Cancer Research UK & UCL Cancer Trials Centre, Belgian Group of Digestive Oncology, National Cancer Institute, France, Cancer Research UK, Taiho Oncology, Inc., Servier, Zymeworks BC Inc., Accord Healthcare, Inc., Pierre Fabre Medicament
Conditions Biliary Tract Neoplasms
Enrollment 800 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov