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A Study to See the Effects That a New Combination of the Three Drugs, Nab-paclitaxel, Gemcitabine, and Cisplatin Has on Biliary Tract Cancer

Study acronym: AX-CSARC
StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Notable Primary and study completion dates: Dec 2024 to Dec 2026v10
  2. Minor Primary and study completion dates: Jun 2024 to Dec 2024v9
  3. Notable Primary completion date: Jan 2020 to Jun 2024
    • Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 1 to 2
    • Study completion date: Jun 2020 to Jun 2024
    v8
  4. Minor Re-verified, no change to tracked fieldsv7
  5. Notable Primary completion date: Jan 2019 to Jan 2020
    • Study completion date: Jan 2019 to Jun 2020
    • Start date: Jul 2016 to Jul 13, 2016
    • Study description expanded, about 153 words
    v6
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  1. Minor Interventions: Combination of nab-paclitaxel, gemcitabine and cisplatin (Drug) to nab-paclitaxel in combination with gemcitabine + cisplatin (Drug)v5
  2. Minor Study completion date: Jan 2019v4
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date: Jun 2016 to Jul 2016
    • Site details revised
    v3
  4. Notable Start date: Jan 2016 to Jun 2016
    • Collaborator revised
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
You are being asked to take part in this study because you have a biliary cancer that is incurable and has spread to other organs. Chemotherapy is often used to help shrink the cancer temporarily and may improve survival. In Canada, the combination of gemcitabine and cisplatin is the chemotherapy combination used to treat biliary cancer that has spread. There is no other known treatment for biliary cancer that has spread to other organs. It is hoped that this new combination of drugs (nab-paclitaxel, gemcitabine, and cisplatin) will improve the tumor shrinkage rate. This study is being done because we do not know whether 2 or 3 chemotherapy drugs is better to treat biliary cancers. We hope to learn whether giving nab-paclitaxel, gemcitabine, and cisplatin together in patients with biliary cancer can increase tumor shrinkage without too many side effects. The purpose of this study is to find out what effects (good and bad) nab-paclitaxel, gemcitabine, and cisplatin has on you and your biliary cancer.
Trial Details
NCT Number NCT02632305
Lead Sponsor AHS Cancer Control Alberta
Collaborators: Celgene
Conditions
(from sponsor)
Unresectable Biliary Tract Cancer
Enrollment 45 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov