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Olaparib in Treating Patients With Metastatic Biliary Tract Cancer With Aberrant DNA Repair Gene Mutations

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Results first posted: May 15, 2026v21 Show 7 more changesShow less
    • Primary completion date changed from estimate of Aug 30, 2024 to Mar 12, 2025
    • Primary endpoint revised
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 36 to confirmed 32
    • Study sites: 6 to 5
    • Study completion date: Mar 30, 2025 to Aug 30, 2026
    • Secondary endpoints revised (5)
  2. Primary completion date: Mar 30, 2024 to Aug 30, 2024v20
  3. Site details revised at 1 of 6 sitesv19
  4. Site contacts updated at 1 of 6 sitesv18
  5. Primary completion date: Sep 30, 2023 to Mar 30, 2024v17 Show 8 more changesShow less
    • Primary endpoint revised
    • Study sites: 5 to 6
    • Study completion date: Sep 30, 2024 to Mar 30, 2025
    • Start date: Jun 9, 2020 to Jun 24, 2020
    • Interventions: Olaparib (Drug) to Biospecimen Collection (Procedure), Computed Tomography (Procedure), Magnetic Resonance Imaging (Procedure), Olaparib (Drug)
    • Eligibility criteria expanded, about 75 words
    • Secondary endpoints: 4 to 5
    • Study description expanded, about 51 words
Show 15 earlier versionsHide 15 earlier versions
  1. Re-verified, no change to tracked fieldsv16
  2. Primary completion date: Sep 30, 2022 to Sep 30, 2023v15
  3. Site details revised at 1 of 5 sitesv14
  4. Primary completion date: Sep 30, 2021 to Sep 30, 2022
    • Study completion date: Sep 30, 2023 to Sep 30, 2024
    v13
  5. Site details revised at 1 of 5 sitesv12
  6. Site contacts updated at 1 of 5 sitesv11
  7. Site contacts updated at 1 of 5 sitesv10
  8. Study sites revised (5)v9
  9. Site contacts updated at 1 of 5 sitesv8
  10. Study sites revised (5)v7
  11. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 30, 2020 to Jun 9, 2020
    • Site details revised at 5 of 5 sites
    v6
  12. Site contacts updated at 1 of 5 sitesv5
  13. Start date: Jan 30, 2020 to Jun 30, 2020
    • Site contacts updated at 1 of 5 sites
    v4
  14. Site contacts updated at 1 of 5 sitesv3
  15. Start date: Sep 30, 2019 to Jan 30, 2020v2
  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.
This phase II trial studies how well olaparib works in treating patients with biliary tract cancer that has spread to other places in the body (metastatic) and with aberrant DNA repair gene mutations. Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Trial Details
NCT Number NCT04042831
Lead Sponsor Academic and Community Cancer Research United
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Bile Duct Adenocarcinoma, Fanconi Anemia Complementation Group Gene Mutation, Metastatic Bile Duct Carcinoma, PTEN Gene Deletion
Related terms Bile Duct Neoplasms
Enrollment 32 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov