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A Phase 1b/2a, Double-blind, Placebo-controlled, Three Arm, Randomized Study Evaluating Continuous Infusion of LSTA1 Over 4 Hours When Added to Standard of Care (SoC) Versus a Single Intravenous (IV) Push of LSTA1 When Added to SoC, Versus SoC Alone in Subjects With Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) Who Have Progressed on FOLFIRINOX (FORTIFIDE)

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A Phase 1b/2a, Double-blind, Placebo-controlled, Three Arm, Randomized Study Evaluating Continuous Infusion of LSTA1 Over 4 Hours When Added to Standard of Care (SoC) Versus a Single Intravenous (IV) Push of LSTA1 When Added to SoC, Versus SoC Alone in Subjects With Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) Who Have Progressed on FOLFIRINOX (FORTIFIDE)

Status: Not yet recruiting
Phase of Trial: Phase I/II

Latest Information Update: 17 Dec 2024

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At a glance

  • Drugs Cerepetide (Primary) ; Gemcitabine; Paclitaxel
  • Indications Adenocarcinoma; Pancreatic cancer
  • Focus Adverse reactions
  • Acronyms FORTIFIDE
  • Sponsors Lisata Therapeutics

    • Most Recent Events

    • 13 Dec 2024 Planned End Date changed from 1 Jun 2027 to 1 Sep 2027.
    • 13 Dec 2024 Planned primary completion date changed from 1 Jun 2027 to 1 Sep 2027.
    • 13 Dec 2024 Planned initiation date changed from 1 Dec 2024 to 1 Mar 2025.

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