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

NCT03366428

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).

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 1

Trial Eligibility

Document

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

DrugSynonymsArms
DS-8201aExperimental productAll 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

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

          -  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

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