HRP20220619T1 - Postupci za liječenje ar+ raka dojke - Google Patents

Postupci za liječenje ar+ raka dojke Download PDF

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Publication number
HRP20220619T1
HRP20220619T1 HRP20220619TT HRP20220619T HRP20220619T1 HR P20220619 T1 HRP20220619 T1 HR P20220619T1 HR P20220619T T HRP20220619T T HR P20220619TT HR P20220619 T HRP20220619 T HR P20220619T HR P20220619 T1 HRP20220619 T1 HR P20220619T1
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HR
Croatia
Prior art keywords
compound
esr1
use according
inhibitors
optionally
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HRP20220619TT
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English (en)
Inventor
Gary Hattersley
Jamal SAEH
Ziyang YU
Chris Miller
Teeru BIHANI
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Ellipses Pharma Ltd
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Publication of HRP20220619T1 publication Critical patent/HRP20220619T1/hr

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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
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4245—Oxadiazoles
    • 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
    • A61K31/275—Nitriles; Isonitriles
    • A61K31/277—Nitriles; Isonitriles having a ring, e.g. verapamil
    • 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
    • A61K31/138—Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine
    • 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
    • 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
    • A61K31/495—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
    • A61K31/506—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further heterocyclic rings
    • 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
    • A61K31/495—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
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • 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
    • A61K31/63—Compounds containing para-N-benzenesulfonyl-N-groups, e.g. sulfanilamide, p-nitrobenzenesulfonyl hydrazide
    • A61K31/635—Compounds containing para-N-benzenesulfonyl-N-groups, e.g. sulfanilamide, p-nitrobenzenesulfonyl hydrazide having a heterocyclic ring, e.g. sulfadiazine
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A61P35/04—Antineoplastic agents specific for metastasis
    • A—HUMAN NECESSITIES
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D413/00—Heterocyclic compounds containing two or more hetero rings, at least one ring having nitrogen and oxygen atoms as the only ring hetero atoms
    • C07D413/02—Heterocyclic compounds containing two or more hetero rings, at least one ring having nitrogen and oxygen atoms as the only ring hetero atoms containing two hetero rings
    • C07D413/10—Heterocyclic compounds containing two or more hetero rings, at least one ring having nitrogen and oxygen atoms as the only ring hetero atoms containing two hetero rings linked by a carbon chain containing aromatic rings
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D413/00—Heterocyclic compounds containing two or more hetero rings, at least one ring having nitrogen and oxygen atoms as the only ring hetero atoms
    • C07D413/02—Heterocyclic compounds containing two or more hetero rings, at least one ring having nitrogen and oxygen atoms as the only ring hetero atoms containing two hetero rings
    • C07D413/12—Heterocyclic compounds containing two or more hetero rings, at least one ring having nitrogen and oxygen atoms as the only ring hetero atoms containing two hetero rings linked by a chain containing hetero atoms as chain links
    • 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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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oncology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nutrition Science (AREA)
  • Physiology (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)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)

Claims (13)

1. Spoj, naznačen time, da je to RAD140 (Spoj III): [image] ili njegova farmaceutski prihvatljiva sol, ili njegov farmaceutski prihvatljiv solvat, za uporabu u postupku liječenja AR+/ER+ raka dojke.
2. Spoj za uporabu prema patentnom zahtjevu 1, naznačen time, da se spoj primjenjuje oralnim putem.
3. Spoj za uporabu prema bilo kojem od patentnih zahtjeva 1 do 2, naznačen time, da: (i) pojedinac se liječi adjuvantnom terapijom; (ii) kod pojedinca je došlo do progresije bolesti nakon liječenja s jednim ili više endokrinoloških sredstava; opcionalno gdje se jedno ili više endokrinoloških sredstava bira iz skupine koju čine SERM-ovi, SERD-ovi, progestini, inhibitori aromataze, i njihove kombinacije; ili (iii) kod navedenog pojedinca je došlo do progresije bolesti nakon liječenja s jednim ili više sredstava koji se biraju iz skupine koju čine CDK4/6 inhibitori, mTOR inhibitori, BCL-2 inhibitori, PI3K inhibitori, i njihove kombinacije.
4. Spoj za uporabu prema bilo kojem od patentnih zahtjeva 1 do 3, naznačen time, da se spoj dozira između 10 i 500 mg, 10 mg i 250 mg, ili 25 mg i 250 mg na dan; opcionalno time, da je doza jednom na dan.
5. Spoj za uporabu prema bilo kojem od patentnih zahtjeva 1 do 4, naznačen time, da pojedinac eksprimira ESR1 koji sadrži jednu ili više mutacija.
6. Spoj za uporabu prema patentnom zahtjevu 5, naznačen time, da: (i) navedena mutacija utječe na afinitet za vezanje liganda u usporedbi s nemutiranim ESR1; opcionalno gdje navedena mutacija rezultira u smanjenju afiniteta estradiola za mutirani ESR1 u usporedbi s nemutiranim ESR1; i/ili (ii) navedena mutacija signalizira kroz ESR1 put ovisno o ligandu ili neovisno o ligandu; i/ili (iii) navedena mutacija ima kao rezultat fuzijski protein koji sadrži najmanje 10 neprekidno povezanih aminokiselina iz slijeda od nemutiranog ESR1 i najmanje 10 neprekidno povezanih aminokiselina iz nekog drugog ljudskog proteina; i/ili (iv) navedena mutacija dovodi do toga da u ESR1 nedostaje 10 ili više uzastopnih aminokiselina iz aminokiselinskog slijeda njegove normalne (nemutirane) domene koja veže ligand; i/ili (v) navedena mutacija sadrži jednu ili više mutacija odabranih iz skupine koju čine ESR1-AKAP12, ESR1-CCDC170, ESR1-YAP1, ESR1-POLH, ESR1-PCDH11X, i njihove kombinacije.
7. Spoj za uporabu prema bilo kojem od patentnih zahtjeva 1 do 6, naznačen time, da liječenje nadalje obuhvaća primjenu CDK4/6 inhibitora; opcionalno gdje navedeni CDK4/6 inhibitor ima IC50 od < 100 nM protiv CDK4 i CDK6.
8. Spoj za uporabu prema patentnom zahtjevu 7, naznačen time, da se navedeni CDK4/6 inhibitor bira iz skupine koju čine palbociklib, ribociklib, trilaciklib, abemaciklib i AMG925.
9. Spoj za uporabu prema patentnom zahtjevu 8, naznačen time, da navedeni CDK4/6 inhibitor jest palbociklib.
10. Spoj za uporabu prema bilo kojem od patentnih zahtjeva 1 do 9, naznačen time, da navedeno liječenje nadalje obuhvaća primjenu: (i) mTOR inhibitora; opcionalno gdje se navedeni mTOR inhibitor bira iz skupine koju čine sirolimus, temsirolimus, everolimus, ridafarolimus, i MLN0128; ili (ii) PI3K inhibitora; opcionalno gdje navedeni PI3K inhibitor je BEZ235, GDC-0980, BKM120, GDC-0941, BYL719, GDC-0032, MK2206, GDC-0068, GSK2110183, GSK2141795, AZD5363, AZD2014, MLN0128 ili CC-223; ili (iii) PARP inhibitora; opcionalno gdje navedeni PARP inhibitor je talazoparib, veliparib, niraparib, beigen290, E7449, KX01, ABT767, CK102, JPI289, KX02, IMP4297, SC10914, NT125, PJ34, VPI289, ili ANG-3186; ili (iv) MCL-1 inhibitora; opcionalno gdje navedeni MCL-1 inhibitor je 7-(5-((4-(4-(N,N-dimetilsulfamoil)pioerazin-1-il)fenoksi)metil)-1,3-dimetil-1H-pirazol-4-il)-1-(2-morfolinoetil)-3-(3-(naftalen-1-iloksi)propil)-1H-indol-2-karboksilna kiselina, S63845, omakataksin, seliciklib, UMI-77, AT101, sabutoklaks, ili TW-37; ili (v) BCL-2 inhibitora; opcionalno gdje navedeni BCL-2 inhibitor je venetoklaks, navitoklaks, ABT737, G3139, ili S55746.
11. Spoj za uporabu prema bilo kojem od patentnih zahtjeva 1 do 10, naznačen time, da navedeni pojedinac jest žena; opcionalno gdje navedena žena je žena u predmenopauzi ili je žena u postmenopauzi.
12. Spoj za uporabu prema bilo kojem od patentnih zahtjeva 1 do 11, naznačen time, da je rak dojke lokaliziran, odmakao ili metastatski.
13. Spoj za uporabu prema patentnom zahtjevu 1, naznačen time, da navedeno liječenje nadalje obuhvaća primjenu terapijskog sredstva odabranog iz skupine koju čine rapamicin, everolimus, ridaforolimus, temsirolimus, MLN0128, CC115, CC223, OSI-027, AZD8055, AZD2014, GDC-0980, SAR245409, LY3023414, NVP-BEZ235, NVP-BGT226, SF1126, i PKI-587.
HRP20220619TT 2016-06-22 2017-06-20 Postupci za liječenje ar+ raka dojke HRP20220619T1 (hr)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201662353350P 2016-06-22 2016-06-22
US201662377497P 2016-08-19 2016-08-19
US201762461546P 2017-02-21 2017-02-21
EP17816081.8A EP3474841B1 (en) 2016-06-22 2017-06-20 Ar+ breast cancer treatment methods
PCT/US2017/038390 WO2017223115A1 (en) 2016-06-22 2017-06-20 Ar+ breast cancer treatment methods

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HRP20220619T1 true HRP20220619T1 (hr) 2023-02-03

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Country Status (20)

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US (3) US20170368036A1 (hr)
EP (2) EP4066827A1 (hr)
JP (2) JP7221699B2 (hr)
KR (3) KR20220035276A (hr)
AU (2) AU2017281038B2 (hr)
CA (1) CA3027563A1 (hr)
DK (1) DK3474841T3 (hr)
ES (1) ES2913470T3 (hr)
HR (1) HRP20220619T1 (hr)
IL (2) IL292659A (hr)
LT (1) LT3474841T (hr)
MX (2) MX2018015724A (hr)
NZ (1) NZ749192A (hr)
PL (1) PL3474841T3 (hr)
PT (1) PT3474841T (hr)
RS (1) RS63311B1 (hr)
RU (2) RU2769527C2 (hr)
SG (1) SG11201811225RA (hr)
SI (1) SI3474841T1 (hr)
WO (1) WO2017223115A1 (hr)

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