At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 51 enrolled
Drug / intervention
DS-8201adrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating DS-8201a for Malignant Neoplasm of Breast. Completed, enrolled 51 participants across 7 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalignant Neoplasm of Breast
CountriesJapan
CollaboratorsAstraZeneca
Timeline
Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedDec 2017
Enrollment StartDec 2017
Primary CompletionDec 2018
Study CompletionFeb 2021
TodayJul 2026
First PostedDec 8, 2017
Enrollment StartDec 26, 2017
Primary CompletionDec 5, 2018
Study CompletionFeb 19, 2021
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 8.6 years ago
Interventions
DS-8201adrug
DS-8201a is supplied as a lyophilized powder which is reconstituted for infusion