RU2017140675A - Способы лечения рака - Google Patents
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- RU2017140675A RU2017140675A RU2017140675A RU2017140675A RU2017140675A RU 2017140675 A RU2017140675 A RU 2017140675A RU 2017140675 A RU2017140675 A RU 2017140675A RU 2017140675 A RU2017140675 A RU 2017140675A RU 2017140675 A RU2017140675 A RU 2017140675A
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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
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
- A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
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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
- A61K31/4353—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 ortho- or peri-condensed with heterocyclic ring systems
- A61K31/436—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 ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin
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- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
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- A61K31/66—Phosphorus compounds
- A61K31/675—Phosphorus compounds having nitrogen as a ring hetero atom, e.g. pyridoxal phosphate
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- A—HUMAN NECESSITIES
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- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/66—Phosphorus compounds
- A61K31/683—Diesters of a phosphorus acid with two hydroxy compounds, e.g. phosphatidylinositols
- A61K31/685—Diesters of a phosphorus acid with two hydroxy compounds, e.g. phosphatidylinositols one of the hydroxy compounds having nitrogen atoms, e.g. phosphatidylserine, lecithin
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- Emergency Medicine (AREA)
- Oncology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Steroid Compounds (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Claims (22)
1. Способ лечения рака молочной железы у субъекта, страдающего от положительного по рецептору эстрогенов альфа рака, который устойчив к лекарственным препаратам и имеет мутантный рецептор эстрогенов альфа, включающий введение указанному субъекту терапевтически эффективного количества комбинации ингибитора cdk4/6 и RAD1901 следующей структуры:
или его соли или сольвата.
2. Способ по п. 1, отличающийся тем, что указанный устойчивый к лекарственным препаратам рак молочной железы является устойчивым к одному или более вариантам антиэстрогеновой терапии или терапии ингибитором ароматазы.
3. Способ по п. 2, отличающийся тем, что указанный один или более антиэстрогенов выбраны из группы, состоящей из тамоксифена, торемифена и фулвестранта, и указанный один или более ингибиторов ароматазы выбраны из группы, состоящей из аромазина, летрозола и анастрозола.
4. Способ по п. 1, отличающийся тем, что у указанного субъекта экспрессируется по меньшей мере один мутантный рецептор эстрогенов альфа, выбранный из группы, состоящей из D538G, Y537S, Y537N, Y537C, E380Q, S463P, L536R, L536Q, Р535Н, V392I и V534E.
5. Способ по п. 4, отличающийся тем, что указанный мутантный рецептор эстрогенов альфа выбран из группы, состоящей из Y537S, Y537N, Y537C, D538G, L536R, S463P и E380Q.
6. Способ по п. 4, отличающийся тем, что указанный мутантный рецептор альфа представляет собой Y537S.
7. Способ по п. 1, отличающийся тем, что указанный RAD1901 вводят в суммарной ежедневной дозе от 100 мг до 1000 мг.
8. Способ по п. 7, отличающийся тем, что указанный RAD 1901 вводят в суммарной ежедневной дозе 100 мг, 200 мг, 300 мг, 400 мг, 500 мг, 600 мг, 700 мг, 800 мг, 900 мг или 1000 мг.
9. Способ по любому из пп. 1-7, отличающийся тем, что указанная ежедневная доза доставляется в виде двух отдельных доз.
10. Способ по п. 9, отличающийся тем, что указанные отдельные дозы представляют собой одинаковые дозы.
11. Способ по п. 1, отличающийся тем, что указанный субъект представляет собой женщину в постменопаузальном периоде.
12. Способ по любому из пп. 1-11, отличающийся тем, что для указанного субъекта впервые установлена необходимость лечения в результате анализа на предмет повышенной экспрессии одного или нескольких генов, выбранных из ABL1, АКТ1, АКТ2, ALK, АРС, AR, ARID1A, ASXL1, ATM, AURKA, ВАР, ВАР1, BCL2L11, BCR, BRAF, BRCA1, BRCA2, CCND1, CCND2, CCND3, CCNE1, CDH1, CDK4, CDK6, CDK8, CDKN1A, CDKN1B, CDKN2A, CDKN2B, СЕВРА, CTNNB1, DDR2, DNMT3A, E2F3, EGFR, EML4, ЕРНВ2, ERBB2, ERBB3, ESR1, EWSR1, FBXW7, FGF4, FGFR1, FGFR2, FGFR3, FLT3, FRS2, HIF1A, HRAS, IDH1, IDH2, IGF1R, JAK2, KDM6A, KDR, KIF5B, KIT, KRAS, LRP1B, МАР2К1, МАР2К4, MCL1, MDM2, MDM4, MET, MGMT, MLL, MPL, MSH6, MTOR, MYC, NF1, NF2, NKX2-1, NOTCH1, NPM, NRAS, PDGFRA, PIK3CA, PIK3R1, PML, PTEN, PTPRD, RARA, RBI, RET, RICTOR, ROS1, RPTOR, RUNX1, SMAD4, SMARCA4, SOX2, STK11, TET2, TP53, TSC1, TSC2 и VHL.
13. Способ по п. 12, отличающийся тем, что указанный один или несколько генов выбраны из АКТ1, АКТ2, BRAF, CDK4, CDK6, PIK3CA, PIK3R1 и MTOR.
14. Способ по п. 1, отличающийся тем, что указанный ингибитор cdk4/cdk6 выбран из группы, состоящей из абемациклиба, рибоциклиба и палбоциклиба.
15. Способ по п. 14, отличающийся тем, что указанный ингибитор cdk4/cdk6 представляет собой палбоциклиб.
16. Способ по п. 15, отличающийся тем, что указанный палбоциклиб вводят в ежедневной дозе от 25 мг до 250 мг.
17. Способ по любому из пп. 15-16, отличающийся тем, что указанный палбоциклиб вводят в течение 21 дня в цикле длительностью 28 дней.
18. Способ по п. 14, отличающийся тем, что указанный ингибитор cdk4/6 представляет собой абемациклиб.
19. Способ по п. 18, отличающийся тем, что указанный абемациклиб вводят в ежедневной дозе 300 мг.
20. Способ по любому из пп. 18-19, отличающийся тем, что указанный абемациклиб вводят в течение 28 дней в цикле длительностью 28 дней.
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