Phase 1 Study to Evaluate the Effect of DS-8201a on the QT/QTc Interval and Pharmacokinetics in HER2-Expressing Breast Cancer
NCT ID: NCT03366428
Last Updated: 2022-04-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
51 participants
INTERVENTIONAL
2017-12-26
2021-02-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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All Participants
All participants will receive DS-8201a by intravenous infusion
DS-8201a
DS-8201a is supplied as a lyophilized powder which is reconstituted for infusion
Interventions
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DS-8201a
DS-8201a is supplied as a lyophilized powder which is reconstituted for infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 ventricular arrhythmias, other than rare occasional premature ventricular contractions
* Has uncontrolled or significant cardiovascular disease
20 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Daiichi Sankyo Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Leader
Role: STUDY_DIRECTOR
Daiichi Sankyo
Locations
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Kanagawa Cancer Center
Yokohama, Kanagawa, Japan
National Cancer Center Hospital
Chuo Ku, Tokyo, Japan
The Cancer Institute Hospital of Japanese Foundation For Cancer Research
Koto-Ku, Tokyo, Japan
Toranomon Hospital
Minato-Ku, Tokyo, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, , Japan
Social Medical Corporation Hakuaikai Sagara Hospital
Kagoshima, , Japan
Shizuoka Cancer Center
Shizuoka, , Japan
Countries
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References
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Shimomura A, Takano T, Takahashi S, Sagara Y, Watanabe J, Tokunaga E, Shinkai T, Kamio T, Kikumori K, Kamiyama E, Fujisaki Y, Saotome D, Yamashita T. Effect of Trastuzumab Deruxtecan on QT/QTc Interval and Pharmacokinetics in HER2-Positive or HER2-Low Metastatic/Unresectable Breast Cancer. Clin Pharmacol Ther. 2023 Jan;113(1):160-169. doi: 10.1002/cpt.2757. Epub 2022 Oct 18.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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173791
Identifier Type: REGISTRY
Identifier Source: secondary_id
DS8201-A-J102
Identifier Type: -
Identifier Source: org_study_id
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