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DK2644194T3 - Kombinationer af et anti-HER2-antistof-lægemiddel-konjugat og docetaxel - Google Patents

Kombinationer af et anti-HER2-antistof-lægemiddel-konjugat og docetaxel Download PDF

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Publication number
DK2644194T3
DK2644194T3 DK13158350.2T DK13158350T DK2644194T3 DK 2644194 T3 DK2644194 T3 DK 2644194T3 DK 13158350 T DK13158350 T DK 13158350T DK 2644194 T3 DK2644194 T3 DK 2644194T3
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DK
Denmark
Prior art keywords
trastuzumab
mcc
combination
therapeutic combination
cancer
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DK13158350.2T
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English (en)
Inventor
Leanne Berry
Gail Lewis Phillips
Mark X Sliwkowski
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Genentech Inc
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    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/535—Heterocyclic 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
    • A61K31/5365—Heterocyclic 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 ortho- or peri-condensed with heterocyclic ring systems
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    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
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    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
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Claims (14)

1. Terapeutisk kombination til anvendelse i en fremgangsmåde til behandling af cancer, der udtrykker ErbB2, hvor fremgangsmåden omfatter at indgive en terapeutisk kombination som en kombineret formulering eller skiftevist til et pattedyr, hvor den terapeutiske kombination omfatter en terapeutisk virksom mængde af trastuzumab-MCC-DM1 og en terapeutisk virksom mængde af docetaxel.
2. Terapeutisk kombination til anvendelse i en fremgangsmåde til behandling ifølge krav 1, hvor den terapeutisk virksomme mængde af trastuzumab-MCC-DM1 og den terapeutisk virksomme mængde af docetaxel indgives som en kombineret formulering.
3. Terapeutisk kombination til anvendelse i en fremgangsmåde til behandling ifølge krav 1, hvor den terapeutisk virksomme mængde af trastuzumab-MCC-DM1 og den terapeutisk virksomme mængde af docetaxel indgives skiftevist.
4. Terapeutisk kombination til anvendelse i en fremgangsmåde til behandling ifølge krav 3, hvor pattedyret får indgivet docetaxel og så efterfølgende trastuzumab-MCC-DM1.
5. Terapeutisk kombination til anvendelse i en fremgangsmåde til behandling ifølge et hvilket som helst af de foregående krav, hvor den terapeutiske kombination indgives med ca. tre ugers mellemrum til et menneske med canceren, der udtrykker ErbB2.
6. Terapeutisk kombination til anvendelse i en fremgangsmåde til behandling ifølge et hvilket som helst af kravene 1 til 4, hvor trastuzumab-MCC-DM1 indgives med fra en uges til tre ugers mellemrum til et menneske med canceren, der udtrykker ErbB2.
7. Terapeutisk kombination til anvendelse i en fremgangsmåde til behandling ifølge et hvilket som helst af de foregående krav, hvor trastuzumab-MCC-DM1 indgives intravenøst ikke oftere end hver 3. uge i en dosis på 2,4, 3,0 eller 3,6 mg/kg.
8. Terapeutisk kombination til anvendelse i en fremgangsmåde til behandling ifølge et hvilket som helst af de foregående krav, hvor mængden af trastuzumab-MCC-DM1 og mængden af docetaxel hver især er fra 1 mg til 1000 mg, og mængden af trastuzumab-MCC-DM1 og mængden af docetaxel er i et vægtforhold på 1:10 til 10:1.
9. Terapeutisk kombination til anvendelse i en fremgangsmåde til behandling ifølge et hvilket som helst af de foregående krav, hvor canceren, der udtrykker ErbB2, er brystcancer.
10. Terapeutisk kombination til anvendelse i en fremgangsmåde til behandling ifølge et hvilket som helst af de foregående krav, hvor pattedyret er en HER2-positiv patient.
11. Terapeutisk kombination til anvendelse i en fremgangsmåde til behandling ifølge et hvilket som helst af de foregående krav, hvor den HER2-positive patient har fået trastuzumab- eller lapatinib-terapi.
12. Terapeutisk kombination til anvendelse i en fremgangsmåde til behandling ifølge et hvilket som helst af de foregående krav, hvor den terapeutiske kombination er en farmaceutisk sammensætning omfattende trastuzumab-MCC-DM1, docetaxel og et eller flere farmaceutisk acceptable bærestoffer, glidemidler, fortyndingsmidler eller hjælpestoffer.
13. Terapeutisk kombination til anvendelse i en fremgangsmåde til behandling ifølge krav 12 , hvor den farmaceutiske sammensætning omfatter et farmaceutisk acceptabelt glidemiddel, der er udvalgt blandt siliciumdioxid, pulveriseret cellulose, mikrokrystallinsk cellulose, metalliske stearater, natrium-aluminiumsilikat, natriumbenzoat, calciumcarbonat, calciumsilikat, majsstivelse, magnesiumcarbonat, asbestfri talkum, stearowet C, stivelse, stivelse 1500, magnesiumlaurylsulfat, magnesiumoxid og kombinationer deraf.
14. Anvendelse af en terapeutisk kombination til fremstilling af et lægemiddel til behandling af brystcancer, hvor den terapeutiske kombination indgives til et pattedyr som en kombineret formulering eller skiftevist og omfatter en terapeutisk virksom mængde af trastuzumab-MCC-DM1 og en terapeutisk virksom mængde af docetaxel.
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