Status:
COMPLETED
Phase 1 Study to Evaluate the Effect of DS-8201a on the QT/QTc Interval and Pharmacokinetics in HER2-Expressing Breast Cancer
Lead Sponsor:
Daiichi Sankyo Co., Ltd.
Collaborating Sponsors:
AstraZeneca
Conditions:
Malignant Neoplasm of Breast
Eligibility:
All Genders
20+ years
Phase:
PHASE1
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 26 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 19 2021
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT03366428
Start Date
December 26 2017
End Date
February 19 2021
Last Update
April 12 2022
Active Locations (7)
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1
Kanagawa Cancer Center
Yokohama, Kanagawa, Japan, 241-8515
2
National Cancer Center Hospital
Chuo Ku, Tokyo, Japan, 104-0045
3
The Cancer Institute Hospital of Japanese Foundation For Cancer Research
Koto-Ku, Tokyo, Japan, 135-8550
4
Toranomon Hospital
Minato-Ku, Tokyo, Japan, 105-8470