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
Latest Information Update: 19 Feb 2024
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
- 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.