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

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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