Study of DS-8201a for Participants With Advanced Solid Malignant Tumors
NCT ID: NCT03383692
Last Updated: 2023-12-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
40 participants
INTERVENTIONAL
2018-01-12
2023-09-11
Brief Summary
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DS-8201a will be tested for safety in patients with advanced solid malignant tumors that test positive for HER2. It also will test how DS-8201a moves within the body (pharmacokinetics).
Detailed Description
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The data for the primary analysis will cutoff after all subjects have either discontinued the study or completed at least 3 cycles, whichever comes first. After the primary analysis, the main study will be closed and transition to the extension period.
Depending on the preliminary results of Cohort 1, Sponsor may decide whether Cohort 2 will be opened or not.
The number of treatment cycles is not fixed in this study. Subjects who continue to derive clinical benefit from the study drug in the absence of withdrawal of consent, progressive disease (PD), or unacceptable toxicity may continue the study drug.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Cohort 1: DS-8201a + Ritonavir
DS-8201a will be administered as an intravenous (IV) solution once every 3 weeks (Q3W) + Ritonavir twice daily (BID) on Day 17 of Cycle 2 until Day 21 of Cycle 3
DS-8201a
DS-8201a is provided as a sterile lyophilized powder of DS-8201a in a glass vial, which will be dissolved and administered as an intravenous (IV) solution
Ritonavir
Ritonavir is a OATP1B inhibitor; an antiretroviral tablet for oral administration
Cohort 2: DS-8201a + Itraconazole
DS-8201a will be administered as an intravenous (IV) solution once every 3 weeks (Q3W) + Itraconazole BID on Day 17 of Cycle 2 followed by 200 mg daily (QD) until Day 21 of Cycle 3
DS-8201a
DS-8201a is provided as a sterile lyophilized powder of DS-8201a in a glass vial, which will be dissolved and administered as an intravenous (IV) solution
Itraconazole
Itraconazole is a CYP3A inhibitor; an antifungal tablet for oral administration
Interventions
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DS-8201a
DS-8201a is provided as a sterile lyophilized powder of DS-8201a in a glass vial, which will be dissolved and administered as an intravenous (IV) solution
Ritonavir
Ritonavir is a OATP1B inhibitor; an antiretroviral tablet for oral administration
Itraconazole
Itraconazole is a CYP3A inhibitor; an antifungal tablet for oral administration
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 myocardial infarction within 6 months before enrollment or symptomatic congestive heart failure
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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Hokkaido Cancer Center
Sapporo, Hokkaido, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Kobe University Hospital
Kobe, Hyōgo, Japan
Hamamatsu University Hospital
Hamamatsu, Shizuoka, Japan
Shizuoka Cancer Center
Nagaizumicho, Shizuoka, Japan
National Cancer Center Hospital
Chuo Ku, Tokyo, Japan
The Cancer Institute Hospital of JFCR
Koto-Ku, Tokyo, Japan
Seoul National University Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
National Taiwan University Hospital
Taipei, , Taiwan
Countries
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References
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Takahashi S, Bando H, Kinoshita I, Modi S, Tsurutani J, Bang YJ, Sato Y, Nakatani S, Lee C, Sugihara M, Okuda Y, Iwata H. Trastuzumab deruxtecan in patients with human epidermal growth factor receptor 2-expressing salivary gland carcinoma: a pooled analysis of two phase I studies. Jpn J Clin Oncol. 2024 Apr 6;54(4):434-443. doi: 10.1093/jjco/hyad181.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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173790
Identifier Type: REGISTRY
Identifier Source: secondary_id
DS8201-A-A104
Identifier Type: -
Identifier Source: org_study_id