RU2011139363A - Схема лечения рака молочной железы с использованием нератиниба - Google Patents
Схема лечения рака молочной железы с использованием нератиниба Download PDFInfo
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- RU2011139363A RU2011139363A RU2011139363/14A RU2011139363A RU2011139363A RU 2011139363 A RU2011139363 A RU 2011139363A RU 2011139363/14 A RU2011139363/14 A RU 2011139363/14A RU 2011139363 A RU2011139363 A RU 2011139363A RU 2011139363 A RU2011139363 A RU 2011139363A
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- neratinib
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- 229950008835 neratinib Drugs 0.000 title claims abstract 29
- ZNHPZUKZSNBOSQ-BQYQJAHWSA-N neratinib Chemical compound C=12C=C(NC\C=C\CN(C)C)C(OCC)=CC2=NC=C(C#N)C=1NC(C=C1Cl)=CC=C1OCC1=CC=CC=N1 ZNHPZUKZSNBOSQ-BQYQJAHWSA-N 0.000 title claims abstract 29
- 238000011282 treatment Methods 0.000 title claims abstract 27
- 206010006187 Breast cancer Diseases 0.000 title 1
- 208000026310 Breast neoplasm Diseases 0.000 title 1
- 229960000575 trastuzumab Drugs 0.000 claims abstract 13
- 230000004083 survival effect Effects 0.000 claims abstract 12
- 206010028980 Neoplasm Diseases 0.000 claims abstract 9
- 201000011510 cancer Diseases 0.000 claims abstract 9
- 238000000034 method Methods 0.000 claims abstract 9
- 201000010099 disease Diseases 0.000 claims abstract 6
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims abstract 6
- 230000009885 systemic effect Effects 0.000 claims abstract 6
- 238000009098 adjuvant therapy Methods 0.000 claims abstract 5
- 101001012157 Homo sapiens Receptor tyrosine-protein kinase erbB-2 Proteins 0.000 claims abstract 4
- 102100030086 Receptor tyrosine-protein kinase erbB-2 Human genes 0.000 claims abstract 4
- 230000003321 amplification Effects 0.000 claims abstract 4
- 238000003199 nucleic acid amplification method Methods 0.000 claims abstract 4
- 230000002018 overexpression Effects 0.000 claims abstract 4
- 208000028715 ductal breast carcinoma in situ Diseases 0.000 claims abstract 3
- 238000001356 surgical procedure Methods 0.000 claims abstract 2
- 238000011269 treatment regimen Methods 0.000 claims abstract 2
- AOJJSUZBOXZQNB-TZSSRYMLSA-N Doxorubicin Chemical compound O([C@H]1C[C@@](O)(CC=2C(O)=C3C(=O)C=4C=CC=C(C=4C(=O)C3=C(O)C=21)OC)C(=O)CO)[C@H]1C[C@H](N)[C@H](O)[C@H](C)O1 AOJJSUZBOXZQNB-TZSSRYMLSA-N 0.000 claims 2
- 238000002512 chemotherapy Methods 0.000 claims 2
- 229940122361 Bisphosphonate Drugs 0.000 claims 1
- CMSMOCZEIVJLDB-UHFFFAOYSA-N Cyclophosphamide Chemical compound ClCCN(CCCl)P1(=O)NCCCO1 CMSMOCZEIVJLDB-UHFFFAOYSA-N 0.000 claims 1
- 208000037396 Intraductal Noninfiltrating Carcinoma Diseases 0.000 claims 1
- 206010073094 Intraductal proliferative breast lesion Diseases 0.000 claims 1
- 239000002136 L01XE07 - Lapatinib Substances 0.000 claims 1
- 208000029725 Metabolic bone disease Diseases 0.000 claims 1
- 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 1
- 206010049088 Osteopenia Diseases 0.000 claims 1
- 208000001132 Osteoporosis Diseases 0.000 claims 1
- 229930012538 Paclitaxel Natural products 0.000 claims 1
- 229940045799 anthracyclines and related substance Drugs 0.000 claims 1
- 229960000397 bevacizumab Drugs 0.000 claims 1
- 150000004663 bisphosphonates Chemical class 0.000 claims 1
- 190000008236 carboplatin Chemical compound 0.000 claims 1
- 229960004562 carboplatin Drugs 0.000 claims 1
- 229960004397 cyclophosphamide Drugs 0.000 claims 1
- 229960003668 docetaxel Drugs 0.000 claims 1
- 229960004679 doxorubicin Drugs 0.000 claims 1
- 201000007273 ductal carcinoma in situ Diseases 0.000 claims 1
- 238000009261 endocrine therapy Methods 0.000 claims 1
- 229940034984 endocrine therapy antineoplastic and immunomodulating agent Drugs 0.000 claims 1
- 229960004891 lapatinib Drugs 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
- 229960001592 paclitaxel Drugs 0.000 claims 1
- 229960002087 pertuzumab Drugs 0.000 claims 1
- RCINICONZNJXQF-MZXODVADSA-N taxol Chemical compound O([C@@H]1[C@@]2(C[C@@H](C(C)=C(C2(C)C)[C@H](C([C@]2(C)[C@@H](O)C[C@H]3OC[C@]3([C@H]21)OC(C)=O)=O)OC(=O)C)OC(=O)[C@H](O)[C@@H](NC(=O)C=1C=CC=CC=1)C=1C=CC=CC=1)O)C(=O)C1=CC=CC=C1 RCINICONZNJXQF-MZXODVADSA-N 0.000 claims 1
- 238000002560 therapeutic procedure Methods 0.000 claims 1
- 229960001612 trastuzumab emtansine Drugs 0.000 claims 1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/47—Quinolines; Isoquinolines
- A61K31/4706—4-Aminoquinolines; 8-Aminoquinolines, e.g. chloroquine, primaquine
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/47—Quinolines; Isoquinolines
- A61K31/4709—Non-condensed quinolines and containing further heterocyclic rings
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
- A61K39/39558—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against tumor tissues, cells, antigens
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
- A61P19/10—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
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Abstract
1. Схема лечения рака со сверхэкспрессией/амплификацией HER-2/neu, включающая проведение лечения нератинибом у пациентов с раком со сверхэкспрессией/амплификацией HER-2/neu после завершения лечения трастузумабом.2. Схема по п.1, где курс лечения нератинибом включает лечение пациентов с раком нератинибом в течение по меньшей мере одного месяца.3. Схема по п.1, где курс лечения нератинибом имеет продолжительность в диапазоне от 8 месяцев до 5 лет.4. Схема по п.2, где пациенты с раком получают лечение нератинибом в течение по меньшей мере приблизительно 12 месяцев.5. Схема по п.1, где лечение нератинибом начинают через от приблизительно 2 недель до приблизительно одного года после завершения хирургического лечения и стандартной адъювантной терапии.6. Схема по п.1, где нератиниб вводят перорально.7. Схема по п.6, где нератиниб вводят в форме таблетки.8. Схема по п.1, где нератиниб вводят ежедневно.9. Схема по п.1, где нератиниб вводят в дозе от 120 мг до 300 мг в сутки.10. Схема по п.9, где нератиниб вводят в дозе 240 мг.11. Способ увеличения выживаемости без признаков инвазивного заболевания (IDFS) или выживаемости без признаков заболевания (DFS) при протоковом раке in situ (DCIS) и/или увеличения общей выживаемости, времени до системного рецидива и выживаемости без признаков системного рецидива у пациента, включающий введение нератиниба указанному пациенту после лечения трастузумабом.12. Способ по п.11, где пациент получил по меньшей мере три цикла лечения трастузумабом.13. Способ по п.12, где пациент получил двенадцать циклов лечения трастузумабом.14. Способ по п.11, где пациент получил стандартную адъювантную терапию, состоящую из трастузумаба и одной или более
Claims (20)
1. Схема лечения рака со сверхэкспрессией/амплификацией HER-2/neu, включающая проведение лечения нератинибом у пациентов с раком со сверхэкспрессией/амплификацией HER-2/neu после завершения лечения трастузумабом.
2. Схема по п.1, где курс лечения нератинибом включает лечение пациентов с раком нератинибом в течение по меньшей мере одного месяца.
3. Схема по п.1, где курс лечения нератинибом имеет продолжительность в диапазоне от 8 месяцев до 5 лет.
4. Схема по п.2, где пациенты с раком получают лечение нератинибом в течение по меньшей мере приблизительно 12 месяцев.
5. Схема по п.1, где лечение нератинибом начинают через от приблизительно 2 недель до приблизительно одного года после завершения хирургического лечения и стандартной адъювантной терапии.
6. Схема по п.1, где нератиниб вводят перорально.
7. Схема по п.6, где нератиниб вводят в форме таблетки.
8. Схема по п.1, где нератиниб вводят ежедневно.
9. Схема по п.1, где нератиниб вводят в дозе от 120 мг до 300 мг в сутки.
10. Схема по п.9, где нератиниб вводят в дозе 240 мг.
11. Способ увеличения выживаемости без признаков инвазивного заболевания (IDFS) или выживаемости без признаков заболевания (DFS) при протоковом раке in situ (DCIS) и/или увеличения общей выживаемости, времени до системного рецидива и выживаемости без признаков системного рецидива у пациента, включающий введение нератиниба указанному пациенту после лечения трастузумабом.
12. Способ по п.11, где пациент получил по меньшей мере три цикла лечения трастузумабом.
13. Способ по п.12, где пациент получил двенадцать циклов лечения трастузумабом.
14. Способ по п.11, где пациент получил стандартную адъювантную терапию, состоящую из трастузумаба и одной или более чем одной химиотерапии.
15. Способ по п.14, где химиотерапия включает одну или более из: терапии на основе доксорубицина, на основе циклофосфамида, на основе паклитаксела, на основе доцетаксела, на основе карбоплатина, на основе лапатиниба, на основе пертузумаба, на основе бевацизумаба, на основе трастузумаба-DM-1 или на основе антрациклина.
16. Схема увеличения выживаемости без признаков инвазивного заболевания, выживаемости без признаков заболевания при протоковом раке in situ, общей выживаемости, времени до системного рецидива и/или выживаемости без признаков системного рецидива, включающая лечение пациентов с раком нератинибом в течение периода продолжительностью по меньшей мере от одного месяца до шести месяцев, которое начинают после адъювантной терапии трастузумабом.
17. Схема по п.16, где пациенты получают лечение нератинибом в течение по меньшей мере двенадцати месяцев.
18. Схема по п.16, где лечение нератинибом начинают через от приблизительно двух недель до приблизительно четырех лет после завершения лечения трастузумабом.
19. Схема по п.16, где лечение нератинибом начинают через от приблизительно шести месяцев до приблизительно двенадцати месяцев после завершения лечения трастузумабом.
20. Схема по п.16, где пациенты дополнительно получают сопутствующее лечение, выбранное из одного или более из бисфосфонатов для лечения остеопении или остеопороза и эндокринной терапии.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US16679609P | 2009-04-06 | 2009-04-06 | |
| US61/166,796 | 2009-04-06 | ||
| PCT/US2010/028448 WO2010117633A1 (en) | 2009-04-06 | 2010-03-24 | Treatment regimen utilizing neratinib for breast cancer |
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| Application Number | Title | Priority Date | Filing Date |
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| RU2014130874A Division RU2685715C2 (ru) | 2009-04-06 | 2014-07-25 | Схема лечения рака молочной железы с использованием нератиниба |
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| RU2011139363A true RU2011139363A (ru) | 2013-05-20 |
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| RU2011139363/14A RU2011139363A (ru) | 2009-04-06 | 2010-03-24 | Схема лечения рака молочной железы с использованием нератиниба |
| RU2014130874A RU2685715C2 (ru) | 2009-04-06 | 2014-07-25 | Схема лечения рака молочной железы с использованием нератиниба |
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| RU2014130874A RU2685715C2 (ru) | 2009-04-06 | 2014-07-25 | Схема лечения рака молочной железы с использованием нератиниба |
Country Status (32)
| Country | Link |
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| US (1) | US9211291B2 (ru) |
| EP (3) | EP2416774B1 (ru) |
| JP (7) | JP5992325B2 (ru) |
| KR (6) | KR20140036332A (ru) |
| CN (3) | CN103989681A (ru) |
| AR (1) | AR076197A1 (ru) |
| AU (1) | AU2010234968B2 (ru) |
| BR (1) | BRPI1012699A2 (ru) |
| CA (1) | CA2755789C (ru) |
| CY (2) | CY1125948T1 (ru) |
| DK (1) | DK3000467T3 (ru) |
| ES (2) | ES2941894T3 (ru) |
| FI (2) | FI3000467T3 (ru) |
| FR (1) | FR23C1027I2 (ru) |
| HR (1) | HRP20230315T1 (ru) |
| HU (2) | HUE061640T2 (ru) |
| IL (4) | IL305394B2 (ru) |
| LT (2) | LT3000467T (ru) |
| LU (1) | LUC00310I2 (ru) |
| MX (1) | MX356593B (ru) |
| NL (1) | NL301237I2 (ru) |
| NO (1) | NO2023028I1 (ru) |
| NZ (1) | NZ595143A (ru) |
| PL (1) | PL3000467T3 (ru) |
| PT (1) | PT3000467T (ru) |
| RU (2) | RU2011139363A (ru) |
| SG (1) | SG174382A1 (ru) |
| SI (1) | SI3000467T1 (ru) |
| SM (1) | SMT202300094T1 (ru) |
| TW (2) | TW201040143A (ru) |
| WO (1) | WO2010117633A1 (ru) |
| ZA (1) | ZA201108118B (ru) |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| RU2405566C9 (ru) | 2005-02-03 | 2012-04-27 | Дзе Дженерал Хоспитал Корпорейшн | Способ лечения рака, устойчивого к гефитинибу |
| PE20070763A1 (es) | 2005-11-04 | 2007-08-08 | Wyeth Corp | COMBINACIONES ANTINEOPLASICAS DE UN INHIBIDOR DE mTOR, TRASTUZUMAB Y/O HKI-272 |
| US8022216B2 (en) | 2007-10-17 | 2011-09-20 | Wyeth Llc | Maleate salts of (E)-N-{4-[3-chloro-4-(2-pyridinylmethoxy)anilino]-3-cyano-7-ethoxy-6-quinolinyl}-4-(dimethylamino)-2-butenamide and crystalline forms thereof |
| DK2310011T3 (da) | 2008-06-17 | 2013-10-14 | Wyeth Llc | Antineoplastiske kombinationer indeholdende hki-272 og vinorelbin |
| SG10202102855RA (en) | 2008-08-04 | 2021-05-28 | Wyeth Llc | Antineoplastic combinations of 4-anilino-3-cyanoquinolines and capecitabine |
| JP5992325B2 (ja) | 2009-04-06 | 2016-09-14 | ワイス・エルエルシー | 乳癌のための、ネラチニブを活用する治療計画 |
| CN102724962B (zh) | 2009-11-09 | 2017-05-17 | 惠氏有限责任公司 | 包衣药物球状体及其用于消除或减少病症比如呕吐和腹泻的用途 |
| KR20200022187A (ko) | 2018-08-22 | 2020-03-03 | 울산대학교 산학협력단 | Nono의 발현 또는 활성 억제제를 유효성분으로 포함하는 방사선 민감성 증진용 조성물 |
| CA3159561A1 (en) | 2019-11-04 | 2021-05-14 | Revolution Medicines, Inc. | Ras inhibitors |
| PE20231207A1 (es) | 2020-09-15 | 2023-08-17 | Revolution Medicines Inc | Derivados indolicos como inhibidores de ras en el tratamiento del cancer |
| PE20240089A1 (es) | 2021-05-05 | 2024-01-16 | Revolution Medicines Inc | Inhibidores de ras para el tratamiento del cancer |
| AR127308A1 (es) | 2021-10-08 | 2024-01-10 | Revolution Medicines Inc | Inhibidores ras |
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| DK4066821T3 (da) | 2009-11-09 | 2025-04-14 | Wyeth Llc | Tabletformuleringer af neratinibmaleat |
| CN102724962B (zh) | 2009-11-09 | 2017-05-17 | 惠氏有限责任公司 | 包衣药物球状体及其用于消除或减少病症比如呕吐和腹泻的用途 |
| NO2719708T3 (ru) | 2009-11-13 | 2018-03-24 | ||
| EP2509592A1 (en) | 2009-12-07 | 2012-10-17 | Boehringer Ingelheim International GmbH | Bibw 2992 for use in the treatment of triple negative breast cancer |
| CA2783743C (en) | 2009-12-11 | 2022-10-04 | Wyeth Llc | Phosphatidylinositol-3-kinase pathway biomarkers |
| US8338456B2 (en) | 2010-01-13 | 2012-12-25 | Wyeth Llc | Cut-point in PTEN protein expression that accurately identifies tumors and is predictive of drug response to a pan-ErbB inhibitor |
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