Phase 1 Study to Evaluate the Effect of DS-8201a on the QT/QTc Interval and Pharmacokinetics in HER2-Expressing Breast Cancer

• Status: Completed
• Trial end date: 2021-02-19
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daiichi Sankyo Co., Ltd.
• Collaborator: AstraZeneca
• Treatments: Camptothecin; Immunoconjugates

Criteria

Inclusion Criteria:

• Has a pathologically documented unresectable or metastatic breast cancer with HER2 expression (immunohistochemistry [IHC] 3+, IHC 2+, IHC 1+ and/or in situ hybridization [ISH] +) that is refractory to or intolerable with standard treatment, or for which no standard treatment is available

• Has a left ventricular ejection fraction (LVEF) ≥ 50%

• Has an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1

Exclusion Criteria:

• Has a medical history of myocardial infarction within 6 months before enrollment

• Has a medical history of ventricular arrhythmias, other than rare occasional premature ventricular contractions

• Has uncontrolled or significant cardiovascular disease