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 PDFInfo
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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
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- docetaxel
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- 238000000034 method Methods 0.000 title claims 14
- 230000000973 chemotherapeutic effect Effects 0.000 title 1
- 150000001875 compounds Chemical class 0.000 title 1
- 229960001612 trastuzumab emtansine Drugs 0.000 claims 9
- ZDZOTLJHXYCWBA-VCVYQWHSSA-N N-debenzoyl-N-(tert-butoxycarbonyl)-10-deacetyltaxol Chemical compound O([C@H]1[C@H]2[C@@](C([C@H](O)C3=C(C)[C@@H](OC(=O)[C@H](O)[C@@H](NC(=O)OC(C)(C)C)C=4C=CC=CC=4)C[C@]1(O)C3(C)C)=O)(C)[C@@H](O)C[C@H]1OC[C@]12OC(=O)C)C(=O)C1=CC=CC=C1 ZDZOTLJHXYCWBA-VCVYQWHSSA-N 0.000 claims 7
- 229960003668 docetaxel Drugs 0.000 claims 7
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 5
- 230000003463 hyperproliferative effect Effects 0.000 claims 5
- 230000001225 therapeutic effect Effects 0.000 claims 4
- 241000124008 Mammalia Species 0.000 claims 3
- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical compound [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 claims 2
- 101001012157 Homo sapiens Receptor tyrosine-protein kinase erbB-2 Proteins 0.000 claims 2
- 102100030086 Receptor tyrosine-protein kinase erbB-2 Human genes 0.000 claims 2
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims 2
- 229920002472 Starch Polymers 0.000 claims 2
- 201000011510 cancer Diseases 0.000 claims 2
- 238000006243 chemical reaction Methods 0.000 claims 2
- 239000000203 mixture Substances 0.000 claims 2
- 239000008194 pharmaceutical composition Substances 0.000 claims 2
- 239000008107 starch Substances 0.000 claims 2
- 235000019698 starch Nutrition 0.000 claims 2
- 229920002261 Corn starch Polymers 0.000 claims 1
- UFHFLCQGNIYNRP-UHFFFAOYSA-N Hydrogen Chemical compound [H][H] UFHFLCQGNIYNRP-UHFFFAOYSA-N 0.000 claims 1
- 239000002136 L01XE07 - Lapatinib Substances 0.000 claims 1
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims 1
- 229910000503 Na-aluminosilicate Inorganic materials 0.000 claims 1
- 239000010425 asbestos Substances 0.000 claims 1
- 229910000019 calcium carbonate Inorganic materials 0.000 claims 1
- 235000010216 calcium carbonate Nutrition 0.000 claims 1
- 239000000378 calcium silicate Substances 0.000 claims 1
- 229910052918 calcium silicate Inorganic materials 0.000 claims 1
- 235000012241 calcium silicate Nutrition 0.000 claims 1
- CJZGTCYPCWQAJB-UHFFFAOYSA-L calcium stearate Chemical class [Ca+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O CJZGTCYPCWQAJB-UHFFFAOYSA-L 0.000 claims 1
- OYACROKNLOSFPA-UHFFFAOYSA-N calcium;dioxido(oxo)silane Chemical compound [Ca+2].[O-][Si]([O-])=O OYACROKNLOSFPA-UHFFFAOYSA-N 0.000 claims 1
- 239000001913 cellulose Substances 0.000 claims 1
- 239000003795 chemical substances by application Substances 0.000 claims 1
- 239000008120 corn starch Substances 0.000 claims 1
- 239000003085 diluting agent Substances 0.000 claims 1
- 239000003937 drug carrier Substances 0.000 claims 1
- 239000012535 impurity Substances 0.000 claims 1
- BCFGMOOMADDAQU-UHFFFAOYSA-N lapatinib Chemical compound O1C(CNCCS(=O)(=O)C)=CC=C1C1=CC=C(N=CN=C2NC=3C=C(Cl)C(OCC=4C=C(F)C=CC=4)=CC=3)C2=C1 BCFGMOOMADDAQU-UHFFFAOYSA-N 0.000 claims 1
- 229960004891 lapatinib Drugs 0.000 claims 1
- ZLNQQNXFFQJAID-UHFFFAOYSA-L magnesium carbonate Chemical compound [Mg+2].[O-]C([O-])=O ZLNQQNXFFQJAID-UHFFFAOYSA-L 0.000 claims 1
- 239000001095 magnesium carbonate Substances 0.000 claims 1
- 229910000021 magnesium carbonate Inorganic materials 0.000 claims 1
- 229940037627 magnesium lauryl sulfate Drugs 0.000 claims 1
- 239000000395 magnesium oxide Substances 0.000 claims 1
- CPLXHLVBOLITMK-UHFFFAOYSA-N magnesium oxide Inorganic materials [Mg]=O CPLXHLVBOLITMK-UHFFFAOYSA-N 0.000 claims 1
- HBNDBUATLJAUQM-UHFFFAOYSA-L magnesium;dodecyl sulfate Chemical compound [Mg+2].CCCCCCCCCCCCOS([O-])(=O)=O.CCCCCCCCCCCCOS([O-])(=O)=O HBNDBUATLJAUQM-UHFFFAOYSA-L 0.000 claims 1
- AXZKOIWUVFPNLO-UHFFFAOYSA-N magnesium;oxygen(2-) Chemical compound [O-2].[Mg+2] AXZKOIWUVFPNLO-UHFFFAOYSA-N 0.000 claims 1
- 229910052751 metal Inorganic materials 0.000 claims 1
- 239000002184 metal Substances 0.000 claims 1
- 239000008108 microcrystalline cellulose Substances 0.000 claims 1
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims 1
- 229940016286 microcrystalline cellulose Drugs 0.000 claims 1
- 239000000546 pharmaceutical excipient Substances 0.000 claims 1
- 235000019814 powdered cellulose Nutrition 0.000 claims 1
- 229920003124 powdered cellulose Polymers 0.000 claims 1
- 229910052895 riebeckite Inorganic materials 0.000 claims 1
- 239000000377 silicon dioxide Substances 0.000 claims 1
- 235000012239 silicon dioxide Nutrition 0.000 claims 1
- 239000000429 sodium aluminium silicate Substances 0.000 claims 1
- 235000012217 sodium aluminium silicate Nutrition 0.000 claims 1
- URGAHOPLAPQHLN-UHFFFAOYSA-N sodium aluminosilicate Chemical compound [Na+].[Al+3].[O-][Si]([O-])=O.[O-][Si]([O-])=O URGAHOPLAPQHLN-UHFFFAOYSA-N 0.000 claims 1
- WXMKPNITSTVMEF-UHFFFAOYSA-M sodium benzoate Chemical compound [Na+].[O-]C(=O)C1=CC=CC=C1 WXMKPNITSTVMEF-UHFFFAOYSA-M 0.000 claims 1
- 239000004299 sodium benzoate Substances 0.000 claims 1
- 235000010234 sodium benzoate Nutrition 0.000 claims 1
- -1 stearovet C Substances 0.000 claims 1
- 230000002195 synergetic effect Effects 0.000 claims 1
- 239000000454 talc Substances 0.000 claims 1
- 229910052623 talc Inorganic materials 0.000 claims 1
- 238000002560 therapeutic procedure Methods 0.000 claims 1
- 229960000575 trastuzumab Drugs 0.000 claims 1
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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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