HRP20180016T1 - Postupci primjene egfr-inhibitora - Google Patents

Postupci primjene egfr-inhibitora Download PDF

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HRP20180016T1
HRP20180016T1 HRP20180016TT HRP20180016T HRP20180016T1 HR P20180016 T1 HRP20180016 T1 HR P20180016T1 HR P20180016T T HRP20180016T T HR P20180016TT HR P20180016 T HRP20180016 T HR P20180016T HR P20180016 T1 HRP20180016 T1 HR P20180016T1
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bibw
pharmaceutically acceptable
acceptable salt
inhibitor
patient
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Robert Michael Lorence
Mehdi Shahidi
Peter Stopfer
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Boehringer Ingelheim International Gmbh
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Publication of HRP20180016T1 publication Critical patent/HRP20180016T1/hr

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic 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
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/517Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with carbocyclic ring systems, e.g. quinazoline, perimidine
    • AHUMAN NECESSITIES
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    • A61K31/33Heterocyclic compounds
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    • A61K31/41Heterocyclic 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
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/535Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
    • A61K31/53751,4-Oxazines, e.g. morpholine
    • A61K31/53771,4-Oxazines, e.g. morpholine not condensed and containing further heterocyclic rings, e.g. timolol
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12QMEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/68Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
    • C12Q1/6876Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes
    • C12Q1/6883Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for diseases caused by alterations of genetic material
    • C12Q1/6886Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for diseases caused by alterations of genetic material for cancer
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/574Immunoassay; Biospecific binding assay; Materials therefor for cancer
    • G01N33/57484Immunoassay; Biospecific binding assay; Materials therefor for cancer involving compounds serving as markers for tumor, cancer, neoplasia, e.g. cellular determinants, receptors, heat shock/stress proteins, A-protein, oligosaccharides, metabolites
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
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    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/74Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving hormones or other non-cytokine intercellular protein regulatory factors such as growth factors, including receptors to hormones and growth factors
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/475Assays involving growth factors
    • G01N2333/485Epidermal growth factor [EGF] (urogastrone)
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00Detection or diagnosis of diseases
    • G01N2800/52Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis

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Claims (7)

1. Farmaceutski sastav, naznačen time, da obuhvaća BIBW 2992 ili njegovu farmaceutski prihvatljivu sol, a služi za uporabu u postupku liječenja pacijenta od raka ne-malih stanica pluća (NSCLC) putem postupka koji obuhvaća sljedeće korake: (a) identificiranje pacijenta kojemu je potrebno liječenje s BIBW 2992 ili s njegovom farmaceutski prihvatljivom soli; (b) utvrđivanje da pacijent prima terapiju s P-gp-inhibitorom odabranim od sljedećih: alfentanil, amilorid, amiodaron, amitriptilin, astemizol, atovakvon, atorvastatin, azelastin, azidopin, azitromicin, bepridil, birikodar, bromokriptin, karbamazepin, karvedilol, klorokin, klorpromazin, klaritromicin, ciklosporin, ciproheptadin, darunavir, desetilamiodaron, dezipramin, deksniguldipin, deksrazoksan, diltiazem, dipiridamol, disulfiram, doksazosin, elakridar, emetin, eritromicin, felodipin, fenofibrat, fentanil, flavonoidi, fluoksetin, flufenazin, fluvoksamin, fucidin, galopamil, gliburid, gramicidin D, sok grejpfruta, češnjak, zeleni čaj, haloperidol, hidrokortizon, hiroksizin, jozamicin, ketokonazol, imipramin, itrakonazol, ivermektin, ketokonazol, lanikvidar, lanzoprazol, levotiroksin, lidokain, loperamid, lopinavir, loratadin, lovastatin, maprotilin, meflokvin, metadon, mibefradil, midazolam, mitomicin C, nefazodon, nelfinavir, nikardipin, nitrendipin, nobiletin, norverapamil, omeprazol, sok naranče, ofloksacin, paroksetin, pantoprazol, fenotiazini, fenobarbital, piperin, pimozid, probenecid, progesteron, prometazin, propafenon, propranolol, kvercetin, kvinakrin, kvinidin, kvinin, rezerpin, ritonavir, sakvinavir, sertralin, simvastatin, spironolakton, sufentanil, takrolimus, tamoksifen, tarikvidar, telitromicin, terfenadin, testosteron, tetrabenazin, tioridazin, trifluoperazin, trifluopromazin, trimipramin, valinomicin, vanadat, venlafaksin, verapamil, vinblastin, FK506, RU486(mifepriston), valspodar 833, zosukvidar i 2n-propilkinolin ili njihove kombinacije; (c) pokretanje pacijentove terapije s P-gp-inhibitorom, tako da se ona zaustavlja prije liječenja s BIBW 2992 ili njegovom farmaceutski prihvatljivom soli; (d) davanje pacijentu BIBW 2992 ili njegovu farmaceutski prihvatljivu sol; (e) nastavljanje terapije s P-gp-inhibitorom ali ne ranije od šest sati nakon davanja BIBW 2992 ili njegove farmaceutski prihvatljive soli.
2. Farmaceutski sastav, naznačen time, da obuhvaća BIBW 2992 ili njegovu farmaceutski prihvatljivu sol, pri čemu se on upotrebljava u postupku liječenja pacijenta od raka ne-malih stanica pluća (NSCLC), dok taj postupak obuhvaća sljedeće korake: (a) utvrđivanje da pacijent prima terapiju s P-gp-inhibitorom odabranim od sljedećih: alfentanil, amilorid, amiodaron, amitriptilin, astemizol, atovakvon, atorvastatin, azelastin, azidopin, azitromicin, bepridil, birikodar, bromokriptin, karbamazepin, karvedilol, klorokin, klorpromazin, klaritromicin, ciklosporin, ciproheptadin, darunavir, desetilamiodaron, dezipramin, deksniguldipin, deksrazoksan, diltiazem, dipiridamol, disulfiram, doksazosin, elakridar, emetin, eritromicin, felodipin, fenofibrat, fentanil, flavonoidi, fluoksetin, flufenazin, fluvoksamin, fucidin, galopamil, gliburid, gramicidin D, sok grejpfruta, češnjak, zeleni čaj, haloperidol, hidrokortizon, hiroksizin, jozamicin, ketokonazol, imipramin, itrakonazol, ivermektin, ketokonazol, lanikvidar, lanzoprazol, levotiroksin, lidokain, loperamid, lopinavir, loratadin, lovastatin, maprotilin, meflokvin, metadon, mibefradil, midazolam, mitomicin C, nefazodon, nelfinavir, nikardipin, nitrendipin, nobiletin, norverapamil, omeprazol, sok naranče, ofloksacin, paroksetin, pantoprazol, fenotiazini, fenobarbital, piperin, pimozid, probenecid, progesteron, prometazin, propafenon, propranolol, kvercetin, kvinakrin, kvinidin, kvinin, rezerpin, ritonavir, sakvinavir, sertralin, simvastatin, spironolakton, sufentanil, takrolimus, tamoksifen, tarikvidar, telitromicin, terfenadin, testosteron, tetrabenazin, tioridazin, trifluoperazin, trifluopromazin, trimipramin, valinomicin, vanadat, venlafaksin, verapamil, vinblastin, FK506, RU486(mifepriston), valspodar 833, zosukvidar i 2n-propilkinolin ili njihove kombinacije; (b) smanjivanje doze ili učestalosti doziranja navedenog P-gp-inhibitora prije početka davanja BIBW 2992 ili njegove farmaceutski prihvatljive soli; i (c) davanje pacijentu BIBW 2992 ili njegove farmaceutski prihvatljive soli.
3. Farmaceutski sastav za uporabu u postupku prema zahtjevu 1 ili 2, naznačen time, da je P-gp-inhibitor odabran od sljedećih: ciklosporin, eritromicin, ketokonazol, itrakonazol, kvinidin, fenobarbitalna sol s kvinidinom, ritonavir, valspodar i verapamil.
4. Farmaceutski sastav za uporabu u postupku prema zahtjevu 1, 2 ili 3, naznačen time, da se BIBW 2992 ili njegova farmaceutski prihvatljiva sol treba davati bez prehrambenih namirnica, što se podrazumijeva da znači najmanje jedan sat prije jela ili do najmanje tri sata nakon jela.
5. BIBW 2992 ili njegova farmaceutski prihvatljiva sol, naznačen/a time, da se upotrebljava u postupku omogućavanja optimalnih terapeutskih učinaka kod liječenja ljudskog pacijenta od NSCLC-a, gdje taj postupak obuhvaća sljedeće korake: (a) utvrđivanje da se pacijentu daje inhibitor od P-glikoproteina (P-gp-inhibitor) odabran od sljedećih: alfentanil, amilorid, amiodaron, amitriptilin, astemizol, atovakvon, atorvastatin, azelastin, azidopin, azitromicin, bepridil, birikodar, bromokriptin, karbamazepin, karvedilol, klorokin, klorpromazin, klaritromicin, ciklosporin, ciproheptadin, darunavir, desetilamiodaron, dezipramin, deksniguldipin, deksrazoksan, diltiazem, dipiridamol, disulfiram, doksazosin, elakridar, emetin, eritromicin, felodipin, fenofibrat, fentanil, flavonoidi, fluoksetin, flufenazin, fluvoksamin, fucidin, galopamil, gliburid, gramicidin D, sok grejpfruta, češnjak, zeleni čaj, haloperidol, hidrokortizon, hiroksizin, jozamicin, ketokonazol, imipramin, itrakonazol, ivermektin, ketokonazol, lanikvidar, lanzoprazol, levotiroksin, lidokain, loperamid, lopinavir, loratadin, lovastatin, maprotilin, meflokvin, metadon, mibefradil, midazolam, mitomicin C, nefazodon, nelfinavir, nikardipin, nitrendipin, nobiletin, norverapamil, omeprazol, sok naranče, ofloksacin, paroksetin, pantoprazol, fenotiazini, fenobarbital, piperin, pimozid, probenecid, progesteron, prometazin, propafenon, propranolol, kvercetin, kvinakrin, kvinidin, kvinin, rezerpin, ritonavir, sakvinavir, sertralin, simvastatin, spironolakton, sufentanil, takrolimus, tamoksifen, tarikvidar, telitromicin, terfenadin, testosteron, tetrabenazin, tioridazin, trifluoperazin, trifluopromazin, trimipramin, valinomicin, vanadat, venlafaksin, verapamil, vinblastin, FK506, RU486(mifepriston), valspodar 833, zosukvidar i 2n-propilkinolin ili njihove kombinacije; (b) smanjivanje doze ili učestalosti doziranja navedenog P-gp-inhibitora ili potpuno izbjegavanje davanja navedenog P-gp-inhibitora prije početka davanja BIBW 2992 ili njegove farmaceutski prihvatljive soli, i (c) davanje BIBW 2992 ili njegove farmaceutski prihvatljive soli pojedincu koji ima navedeni rak.
6. BIBW 2992 ili njegova farmaceutski prihvatljiva sol, za uporabu u postupku prema zahtjevu 5, naznačen/a time, da je P-gp-inhibitor odabran od sljedećih: ciklosporin, eritromicin, ketokonazol, itrakonazol, kvinidin, fenobarbitalna sol s kvinidinom, ritonavir, valspodar i verapamil.
7. BIBW 2992 ili njegova farmaceutski prihvatljiva sol, za uporabu u postupku prema zahtjevu 5 ili 6, naznačen/a time, da se BIBW 2992 ili njegova farmaceutski prihvatljiva sol treba davati bez prehrambenih namirnica, što se podrazumijeva da znači najmanje jedan sat prije jela ili do najmanje tri sata nakon jela.
HRP20180016TT 2010-08-26 2018-01-05 Postupci primjene egfr-inhibitora HRP20180016T1 (hr)

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Application Number Priority Date Filing Date Title
US37717710P 2010-08-26 2010-08-26
EP11752700.2A EP2608792B1 (en) 2010-08-26 2011-08-24 Methods of administering an egfr inhibitor
PCT/US2011/048922 WO2012027445A1 (en) 2010-08-26 2011-08-24 Methods of administering an egfr inhibitor

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US (2) US20130289056A1 (hr)
EP (1) EP2608792B1 (hr)
JP (3) JP2013536244A (hr)
CY (1) CY1119898T1 (hr)
DK (1) DK2608792T3 (hr)
EC (1) ECSP13012523A (hr)
ES (1) ES2655115T3 (hr)
HR (1) HRP20180016T1 (hr)
HU (1) HUE038049T2 (hr)
LT (1) LT2608792T (hr)
NO (1) NO2608792T3 (hr)
PL (1) PL2608792T3 (hr)
PT (1) PT2608792T (hr)
RS (1) RS56682B1 (hr)
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WO (1) WO2012027445A1 (hr)

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PL2608792T3 (pl) 2018-03-30
HUE038049T2 (hu) 2018-09-28
US20130289056A1 (en) 2013-10-31
EP2608792B1 (en) 2017-10-11
JP2017081966A (ja) 2017-05-18
NO2608792T3 (hr) 2018-03-10
JP2013536244A (ja) 2013-09-19
RS56682B1 (sr) 2018-03-30
PT2608792T (pt) 2018-01-15
ECSP13012523A (es) 2013-05-31
CY1119898T1 (el) 2018-06-27
SI2608792T1 (en) 2018-02-28
JP2019147814A (ja) 2019-09-05
ES2655115T3 (es) 2018-02-16
DK2608792T3 (en) 2018-01-15
WO2012027445A1 (en) 2012-03-01
EP2608792A1 (en) 2013-07-03
LT2608792T (lt) 2018-01-10
JP6541637B2 (ja) 2019-07-10
US20160287591A1 (en) 2016-10-06

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