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Cholesterol Disruption in Combination With the Standard of Care in Patients With Advanced Pancreatic Adenocarcinoma

StatusActive, Not Recruiting
PhaseEarly Phase 1
Started
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Record History

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  1. Minor Re-verified, no change to tracked fieldsv11
  2. Minor Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 12 to confirmed 3
    • Site details revised at 2 of 2 sites
    v10
  3. Minor Re-verified, no change to tracked fieldsv9
  4. Minor Eligibility criteria shortened, about 6 words
    • Study title expanded, about 3 words
    v8
  5. Minor Primary completion date: Dec 31, 2025 to Jan 31, 2025
    • Eligibility criteria shortened, about 8 words
    • Site details revised at 2 of 2 sites
    v7
Show 5 earlier versionsHide 5 earlier versions
  1. Notable Primary completion date: Jun 2023 to Dec 31, 2025v6 Show 4 more changesShow less
    • Study sites: 1 to 2
    • Study completion date: Jun 2023 to Dec 31, 2026
    • Start date: Nov 4, 2021 to Oct 4, 2021
    • Eligibility criteria expanded, about 2 words
  2. Minor Eligibility criteria expanded, about 160 words
    • Secondary endpoints: 7 to 8
    • Site contact updated
    • Study title revised
    v5
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 2021 to Nov 4, 2021
    • Site details revised
    v4
  4. Notable Start date: Jun 2021 to Sep 2021v3
  5. Minor Study Status, Conditions, Contacts/Locationsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Cardiovascular diseases and cancers, the two leading causes of death in Canada, require cholesterol to sustain their progression. All cells require cholesterol, but cancer cells have much higher needs to sustain growth, division and metastasis. The availability of new cholesterol-lowering drugs developed to protect patients from heart diseases has resulted in unprecedented low levels of cholesterol. The combination of atorvastatin, ezetimibe and Repatha, which are 3 cholesterol-lowering drugs used in combination, is safe, well tolerated and efficient over years of treatment. Recent reports indicate that abundant cholesterol supplies are required to sustain the progression of pancreatic ductal adenocarcinomas. This proof-of-concept study aims to verify the feasibility, the acceptability and gain preliminary data on adding a cholesterol shortage on top of FOLFIRINOX (standard chemotherapy) in newly diagnosed patients with locally advanced pancreatic adenocarcinomas or metastatic pancreatic adenocarcinomas. It is expected that a drug-induced cholesterol shortage will slow-down or stop the progression of pancreatic adenocarcinomas while increasing the response to chemotherapy.
Trial Details
NCT Number NCT04862260
Lead Sponsor CHU de Quebec-Universite Laval
Collaborators: Canadian Institutes of Health Research (CIHR), Biovalorem
Conditions
(from sponsor)
Pancreatic Ductal Adenocarcinoma, Pancreatic Cancer, Pancreas Cancer, Metastatic Cancer
Related terms Hyperlipoproteinemia Type II, Neoplasm Metastasis, Neoplasms, Pancreatic Neoplasms
Enrollment 3 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov