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A Phase 1, Multicenter, Open-label, Single Sequence Crossover Study to Evaluate Drug-drug Interaction Potential of OATP1B/CYP3A Inhibitor on the Pharmacokinetics of DS-8201a in Subjects With HER2-expressing Advanced Solid Malignant Tumors

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Trial Profile

A Phase 1, Multicenter, Open-label, Single Sequence Crossover Study to Evaluate Drug-drug Interaction Potential of OATP1B/CYP3A Inhibitor on the Pharmacokinetics of DS-8201a in Subjects With HER2-expressing Advanced Solid Malignant Tumors

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 19 Feb 2024

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At a glance

  • Drugs Trastuzumab-deruxtecan (Primary) ; Itraconazole; Ritonavir
  • Indications Adenocarcinoma; Advanced breast cancer; Colorectal cancer; Gastric cancer; HER2 positive breast cancer; Non-small cell lung cancer; Salivary gland cancer; Solid tumours
  • Focus Pharmacokinetics
  • Sponsors Daiichi Sankyo Company
  • Most Recent Events

    • 07 Dec 2023 Status changed from active, no longer recruiting to completed.
    • 07 Sep 2023 Planned End Date changed from 30 Sep 2023 to 31 Mar 2024.
    • 22 Mar 2023 Planned End Date changed from 31 Mar 2023 to 30 Sep 2023.

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