Trials / Completed
CompletedNCT03366428
Phase 1 Study to Evaluate the Effect of DS-8201a on the QT/QTc Interval and Pharmacokinetics in HER2-Expressing Breast Cancer
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
- Phase 1
- Study type
- Interventional
- Enrollment
- 51 (actual)
- Sponsor
- Daiichi Sankyo Co., Ltd. · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
This study will look at the effect on the QTc interval and pharmacokinetics after multiple dosing in subjects with HER2-expressing metastatic and/or unresectable breast cancer.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | DS-8201a | DS-8201a is supplied as a lyophilized powder which is reconstituted for infusion |
Timeline
- Start date
- 2017-12-26
- Primary completion
- 2018-12-05
- Completion
- 2021-02-19
- First posted
- 2017-12-08
- Last updated
- 2022-04-12
- Results posted
- 2021-06-14
Locations
7 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT03366428. Inclusion in this directory is not an endorsement.