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Proglumide and Chemotherapy for Metastatic Pancreatic Cancer

Study acronym: ProGem
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv10
  2. Trial status: Recruiting to Active, Not Recruiting Primary completion date: Jul 2027 to Jan 2027 · Completion date: Nov 2027 to Jan 2027 · Site details revisedv9 Show 3 more changesShow less
    • Primary completion date: Jul 2027 to Jan 2027
    • Completion date: Nov 2027 to Jan 2027
    • Site details revised
  3. Site contact updatedv8
  4. Re-verified, no change to tracked fieldsv7
  5. Start date changed from estimate of Jan 2024 to Jan 31, 2024v6
Show 4 earlier versionsHide 4 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting Start date: Dec 2023 to Jan 2024 · Site details revisedv5 Show 2 more changesShow less
    • Start date: Dec 2023 to Jan 2024
    • Site details revised
  2. Re-verified, no change to tracked fieldsv4
  3. Phase: Phase 1 to Phase 2 Enrollment target: 12 to 30 · Primary completion date: Jul 2026 to Jul 2027 · Start date: Jul 2023 to Dec 2023 · 8 morev3 Show 11 more changesShow less
    • Enrollment target: 12 to 30
    • Primary completion date: Jul 2026 to Jul 2027
    • Start date: Jul 2023 to Dec 2023
    • Primary endpoint revised
    • Completion date: Jul 2026 to Nov 2027
    • Interventions: Gemcitabine (Drug), Nab paclitaxel (Drug), Proglumide Dose level 1 (Drug), Proglumide Dose level 2 (Drug) to Gemcitabine (Drug), Nab paclitaxel (Drug), Placebo (Drug), Proglumide (Drug)
    • Eligibility criteria shortened, about 10 words
    • Secondary endpoints revised (4)
    • Study description expanded, about 241 words
    • Site contact updated
    • Study title shortened, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  4. Re-verified, no change to tracked fieldsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 is a Phase 2 study with an open labelled lead-in study to approximately treat 30 patients \[6 subjects for Lead-in and 24 for Phase 2\] enrolled with metastatic pancreatic cancer with combination therapy using standard of care first line therapy with GEM-NAB-P (GEM 1000mg/m2 IV and NAB-P 125 mg/m2 given days 1, 8, and 15 every 28 days, and proglumide will be tested at the daily dose of 1200 mg orally given as 400 mg po TID. The lead-in study will determine the safety and tolerability of the 1200 mg daily dose of proglumide with standard of care GEM-NAB-P. If 0 or 1 of a total of 6 patients at 400mg experiences a DLT, then we will proceed to the Phase 2 randomized trial.
Trial Details
NCT Number NCT05827055
Lead Sponsor Georgetown University
Conditions Metastatic Pancreatic Cancer
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov