RU2018136076A - Комбинации конъюгата анти-her2-антитело-лекарственное средство и химиотерапевтических средств и способы применения - Google Patents

Комбинации конъюгата анти-her2-антитело-лекарственное средство и химиотерапевтических средств и способы применения Download PDF

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RU2018136076A
RU2018136076A RU2018136076A RU2018136076A RU2018136076A RU 2018136076 A RU2018136076 A RU 2018136076A RU 2018136076 A RU2018136076 A RU 2018136076A RU 2018136076 A RU2018136076 A RU 2018136076A RU 2018136076 A RU2018136076 A RU 2018136076A
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trastuzumab
mcc
docetaxel
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RU2781195C2 (ru
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Линн БЕРРИ
Гейл Льюис ФИЛЛИПС
Марк Кс. СЛИВКОВСКИ
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Дженентек, Инк.
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Claims (15)

1. Способ лечения гиперпролиферативного нарушения, включающий введение терапевтической комбинации в виде комбинированной композиции или поочередно млекопитающему, где терапевтическая комбинация содержит трастузумаб-МСС-DM1 и доцетаксел.
2. Способ по п. 1, где трастузумаб-МСС-DM1 и доцетаксел вводят в виде комбинированной композиции.
3. Способ по п. 1, где трастузумаб-МСС-DM1 и доцетаксел вводят поочередно.
4. Способ по п. 3, где млекопитающему вводят доцетаксел и затем впоследствии вводят трастузумаб-MCC-DM1.
5. Способ по любому из пп. 1-4, где терапевтическую комбинацию вводят человеку с гиперпролиферативным нарушением с интервалами три недели.
6. Способ по п. 3, где трастузумаб-MCC-DM1 вводят человеку с гиперпролиферативным нарушением с интервалами от одной недели до трех недель.
7. Способ по п. 3, где трастузумаб-MCC-DM1 вводят не чаще, чем каждые 3 недели при дозировке 2,4, 3,0, или 3,6 мг/кг внутривенно.
8. Способ по любому из пп. 1-7, где количество трастузумаба-MCC-DM1 и количество доцетаксела составляет для каждого от 1 мг до 1000 мг, и количество трастузумаба-MCC-DM1 и количество доцетаксела находятся в соотношении от 1:10 до 10:1 по массе.
9. Способ по любому из пп. 1-8, где гиперпролиферативное нарушение представляет собой злокачественную опухоль.
10. Способ по любому из пп. 1-8, где гиперпролиферативное нарушение представляет собой злокачественную опухоль, экспрессирующую ErbB2.
11. Способ по п. 10, где млекопитающим является пациент с положительных реакций на HER2.
12. Способ по п. 11, где пациент с положительных реакций на HER2 получал терапию трастузумабом или лапатинибом.
13. Способ по любому из пп. 1-12, где введение терапевтической комбинации приводит к синергетическому результату.
14. Фармацевтическая композиция, содержащая трастузумаб-МСС-DM1 и доцетаксел и один или несколько фармацевтически приемлемых носителей, регуляторов сыпучести, разбавителей или наполнителей.
15. Фармацевтическая композиция по п.14, содержащая фармацевтически приемлемый регулятор сыпучести, выбранный из диоксида кремния, порошкообразной целлюлозы, микрокристаллической целлюлозы, стеаратов металлов, алюмосиликата натрия, бензоата натрия, карбоната кальция, силиката кальция, кукурузного крахмала, карбоната магния, не содержащего примеси асбеста талька, стеаровета C, крахмала, крахмала 1500, лаурилсульфата магния, оксида магния и их комбинаций.
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