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Phase I Study of Irinotecan Liposome (Nal-IRI), Fluorouracil and Rucaparib in the Treatment of Select Gastrointestinal Metastatic Malignancies Followed by a Phase Ib of First and Second Line Treatment of Both Unselected and Selected (for BRCA 1/2 and PALB2 Mutations) Patients With Metastatic Adenocarcinoma of the Pancreas Then Followed by a Phase II Study of First Line Treatment of Selected Patients With Metastatic Adenocarcinoma of the Pancreas With Genomic Markers (Signature) of Homologous Recombination Deficiency (HRD)

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Trial Profile

Phase I Study of Irinotecan Liposome (Nal-IRI), Fluorouracil and Rucaparib in the Treatment of Select Gastrointestinal Metastatic Malignancies Followed by a Phase Ib of First and Second Line Treatment of Both Unselected and Selected (for BRCA 1/2 and PALB2 Mutations) Patients With Metastatic Adenocarcinoma of the Pancreas Then Followed by a Phase II Study of First Line Treatment of Selected Patients With Metastatic Adenocarcinoma of the Pancreas With Genomic Markers (Signature) of Homologous Recombination Deficiency (HRD)

Status: Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 21 May 2024

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At a glance

  • Drugs Fluorouracil (Primary) ; Folinic acid (Primary) ; Irinotecan (Primary) ; Rucaparib (Primary)
  • Indications Adenocarcinoma; Biliary cancer; Colorectal cancer; Gastric cancer; Oesophageal cancer; Pancreatic cancer
  • Focus Adverse reactions

    • Most Recent Events

    • 05 Apr 2024 Efficacy end-points Objective response (Phase Ib) and Best response rate (Phase II) are removed, thus making AR the only focus.
    • 29 Nov 2023 Planned End Date changed from 24 Aug 2025 to 9 Aug 2025.
    • 29 Nov 2023 Planned primary completion date changed from 24 Aug 2023 to 9 Feb 2024.

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