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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

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Completed

Phase:

Phase 1

Trial Eligibility

Document

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

DrugSynonymsArms
DS-8201aExperimental productAll 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

NameTypeDescriptionInterventions
All ParticipantsExperimentalAll participants will receive DS-8201a by intravenous infusion
  • DS-8201a

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