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A Phase 1b, Open-label Study to Assess the Safety and Tolerability of Tucatinib (ONT-380) Combined With Ado-trastuzumab Emtansine (Trastuzumab Emtansine; T-DM1)

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Trial Profile

A Phase 1b, Open-label Study to Assess the Safety and Tolerability of Tucatinib (ONT-380) Combined With Ado-trastuzumab Emtansine (Trastuzumab Emtansine; T-DM1)

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 27 Oct 2023

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At a glance

  • Drugs Tucatinib (Primary) ; Trastuzumab emtansine
  • Indications Advanced breast cancer; HER2 positive breast cancer; Male breast cancer
  • Focus Adverse reactions
  • Sponsors Cascadian Therapeutics; Seagen
  • Most Recent Events

    • 12 Sep 2023 Results (n=283 from studies ONT-380-004,ONT-380-005 and SGNTUC-017) assessing Population Pharmacokinetic Analysis of Tucatinib in Healthy Subjects & Subjects With HER2+ Metastatic Breast Cancer or Metastatic Colorectal Cancer presented at the 2023 American College of Clinical Pharmacology Annual Meeting
    • 19 Apr 2020 Status changed from active, no longer recruiting to completed.
    • 07 Feb 2020 Planned End Date changed from 1 Jan 2020 to 31 Mar 2020.
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