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Phase 1, Multicenter, Open-Label, Multiple-Dose Study of DS-8201a to Assess the Effect on the QT Interval, and Pharmacokinetics in Subjects with HER2-Expressing Metastatic and/or Unresectable Breast Cancer

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Trial Profile

Phase 1, Multicenter, Open-Label, Multiple-Dose Study of DS-8201a to Assess the Effect on the QT Interval, and Pharmacokinetics in Subjects with HER2-Expressing Metastatic and/or Unresectable Breast Cancer

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 19 Feb 2024

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At a glance

  • Drugs Trastuzumab-deruxtecan (Primary)
  • Indications Advanced breast cancer; HER2 negative breast cancer; HER2 positive breast cancer; Male breast cancer
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Daiichi Sankyo Company

    • Most Recent Events

    • 27 Sep 2022 Results evaluating effects of trastuzumab deruxtecan on QT/QTc interval and its pharmacokinetics,published in the Clinical Pharmacology and Therapeutics
    • 17 May 2021 Status changed from active, no longer recruiting to completed.
    • 17 May 2021 Data for characterizing T-DXd exposure-response relationships with respect to key efficacy and safety endpoints was used from from (J101 [NCT02564900], J102 [NCT03366428], A103 [NCT03368196 & A104 [NCT03383692]) and a phase 2 study (DESTINY-Breast 01 [U201; NCT03248492) published in the Clinical Pharmacology and Therapeutics.
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