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Sponsor: Daiichi Sankyo Co., Ltd.
Conditions: Neoplasm Metastasis
Interventions: DS-8201a, Ritonavir, Itraconazole
Countries: Japan, South Korea, Taiwan
HER2-positive cancer is a cancer that tests positive for a protein called human epidermal growth factor receptor 2 (HER2). HER2 promotes the growth of certain cancer cells. This study will test an experimental drug called DS-8201a that has not been approved by the health authorities yet. 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).
Sex: ALL
Age: 20 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion 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
- Sapporo, Hokkaido, Japan
- Sapporo, Hokkaido, Japan
- Kobe, Hyōgo, Japan
- Hamamatsu, Shizuoka, Japan
- Nagaizumicho, Shizuoka, Japan
- Chuo Ku, Tokyo, Japan
- Koto-Ku, Tokyo, Japan
- Seoul, South Korea
- Seoul, South Korea
- Taipei, Taiwan