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

NCT03366428 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2022-04-12

Study results available
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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.

Conditions

  • Malignant Neoplasm of Breast

Interventions

DRUG

DS-8201a

DS-8201a is supplied as a lyophilized powder which is reconstituted for infusion

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Daiichi Sankyo Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Global Clinical Leader · Daiichi Sankyo

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-26
Primary Completion
2018-12-05
Completion
2021-02-19

Countries

  • Japan

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03366428 on ClinicalTrials.gov