Clinical Trials List
2018-04-03 - 2019-04-30
Phase I
Terminated3
ICD-10C50
Malignant neoplasm of breast
A Phease1, Multicenter, Open-Label, Single Sequence Crossover Study to Evaluate Drug-Drug Interaction Potential of OATP1B/CYP3A Inhibitor on The Pharmacokinetics of DS-8201a in Subjects with HER2-Expressing Advanced Solid Malignant Tumors 一項第一期、多中心、開放標示、單一順序交叉試驗，評估在HER2表現型晚期實質惡性腫瘤受試者中，OATP1B/CYP3A抑制劑對DS-8201a藥物動力學發生藥物交互作用的可能性
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Trial Applicant
Daiichi Sankyo Taiwan Ltd.
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Sponsor
Daiichi Sankyo Co., Ltd
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Audit
None
The Actual Total Number of Participants Enrolled
0 Terminated
Audit
None
The Actual Total Number of Participants Enrolled
0 Completed
Audit
None
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
• PK parameters (Cmax and AUC0-17d) of DS-8201a and MAAA-1181a (±
ritonavir)
• PK parameters (Cmax and AUC0-17d) of DS-8201a and MAAA-1181a (±
itraconazole)
Inclution Criteria
Has a pathologically documented unresectable or metastatic solid malignant tumor, with HER2 expression [immunohistochemistry (IHC) 3+, 2+, or 1+ and/or in situ hybridization (ISH) +], Next Generation Sequencing, or other analysis techniques as appropriate] that is refractory to or intolerable with at least one prior systemic chemotherapy regimen, 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 contraindication for receiving ritonavir or itraconazole according to the prescribing information
Has a medical history of myocardial infarction within 6 months before enrollment or symptomatic congestive heart failure
The Estimated Number of Participants
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Taiwan
6 participants
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Global
32 participants
