Description:
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.
Title
- Brief Title: Phase 1 Study to Evaluate the Effect of DS-8201a on the QT/QTc Interval and Pharmacokinetics 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
- SECONDARY ID:
173791
- 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 on the QTc interval and pharmacokinetics after multiple
dosing in subjects with HER2-expressing metastatic and/or unresectable breast cancer.
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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 20 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Changes in QTcF After Treatment With DS-8201a in Participants With HER2-expressing Metastatic and/or Unresectable Breast Cancer |
| Time Frame: | Screening (within 7 days before enrollment) up to Cycle 3 Day 15 (each cycle is 21 days) |
| Safety Issue: | |
| Description: | The number of participants with notable electrocardiogram changes meeting predefined criteria is being reported. |
Secondary Outcome Measures
| Measure: | Objective Response Rate Based on The Investigator's Assessment (Unconfirmed) Following DS-8201a Treatment in Participants With HER2-expressing Metastatic and/or Unresectable Breast Cancer |
| Time Frame: | Baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever occurs first), up to approximately 12 months post-dose |
| Safety Issue: | |
| Description: | Objective response rate (ORR) was defined as unconfirmed complete response (CR) and partial response (PR) as assessed by the investigator based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. |
| Measure: | Treatment-Emergent Adverse Events of Any Grade by Preferred Term Following DS-8201a Treatment in Participants With HER2-expressing Metastatic and/or Unresectable Breast Cancer |
| Time Frame: | Baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever occurs first), up to approximately 12 months post-dose |
| Safety Issue: | |
| Description: | Adverse events (AEs) were to be coded using MedDRA Version 20.1 and assigned severity grades based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03. A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after initiating the study drug until 47 days after last dose of study drug. |
Details
| Phase: | Phase 1 |
| Primary Purpose: | Interventional |
| Overall Status: | Completed |
| Lead Sponsor: | Daiichi Sankyo Co., Ltd. |
Trial Keywords
- HER2
- Breast cancer
- Oncology
- Antibody drug conjugate
- ADC
Last Updated
July 7, 2021
