Description:
This study will look at the effect of DS-8201a on heart rate and the movement of the drug
through the body (pharmacokinetics) in participants with a certain type of breast cancer
(HER2).
Title
- Brief Title: Phase 1 Study to Evaluate the Effect of DS-8201a on the QT/QTc Interval in HER2-Expressing Breast Cancer
- Official Title: 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
Clinical Trial IDs
- ORG STUDY ID:
DS8201-A-J102
- NCT ID:
NCT03366428
Conditions
- Malignant Neoplasm of Breast
Interventions
Drug | Synonyms | Arms |
---|
DS-8201a | Experimental product | All Participants |
Purpose
This study will look at the effect of DS-8201a on heart rate and the movement of the drug
through the body (pharmacokinetics) in participants with a certain type of breast cancer
(HER2).
Trial Arms
Name | Type | Description | Interventions |
---|
All Participants | Experimental | All participants will receive DS-8201a by intravenous infusion | |
Eligibility 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
- Has any other history or condition that might compromise:
1. Safety of the participant or offspring
2. Safety of study staff
3. Analysis of Results
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 20 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Average baseline-adjusted QT interval corrected for heart rate by Fridericia's formula (QTcF ) |
Time Frame: | Cycle 1 to 3 (approximately 63 days) |
Safety Issue: | |
Description: | The QT intervals will be corrected for heart rate by Fridericia's formula (QTcF = QT/[RR]1/3). The baseline QTcF interval for each subject will be subtracted from QTcF interval to create a baseline-adjusted QTcF interval. |
Secondary Outcome Measures
Measure: | Objective Response Rate (ORR) |
Time Frame: | within 17 months |
Safety Issue: | |
Description: | ORR is defined as the percentage of participants who achieve a best overall response of complete response (CR) or partial response (PR), as assessed by the investigator based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 |
Measure: | Disease Control Rate (DCR) |
Time Frame: | within 17 months |
Safety Issue: | |
Description: | DCR is defined as the percentage of participants who achieve a best overall response of CR or PR or stable disease (SD) |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Daiichi Sankyo Co., Ltd. |
Trial Keywords
- HER2
- Breast cancer
- Oncology
- Antibody drug conjugate
- ADC
Last Updated