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1. WO2016096933 - MASITINIB COMBINÉ À UTILISER DANS LE TRAITEMENT DU CANCER DU SEIN

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CLAIMS

1. A method for treating breast cancer in a subject in need thereof, comprising administering to said subject a therapeutically effective amount of a c-Kit inhibitor or mast cell inhibitor or a pharmaceutically acceptable salt or solvate thereof, in combination with a therapeutically effective amount of at least one chemotherapeutic agent.

2. The method according to claim 1, wherein the c-Kit inhibitor or mast cell inhibitor is an inhibitor of c-Kit, Lyn, Fyn and/or PDGFR a and β.

3. The method according to anyone of claims 1 to 2, wherein the c-Kit inhibitor or mast cell inhibitor is masitinib or a pharmaceutically acceptable salt or solvate thereof.

4. The method according to anyone of claims 1 to 3, wherein the pharmaceutically acceptable salt or solvate of masitinib is masitinib mesilate.

5. The method according to anyone of claims 1 to 4, for improving survival and/or life expectancy of the subject.

6. The method according to anyone of claims 1 to 5, comprising sensitizing to a chemotherapeutic agent or restoring sensitivity to chemotherapy in the subject.

7. The method according to anyone of claims 1 to 6, wherein breast cancer is advanced breast cancer, preferably locally advanced breast cancer or metastatic breast cancer.

8. The method according to anyone of claims 1 to 7, wherein breast cancer is triple- negative breast cancer (TNBC), preferably advanced TNBC, more preferably locally advanced TNBC or metastatic TNBC.

9. The method according to anyone of claims 1 to 8, wherein breast cancer is inflammatory breast cancer (IBC), preferably advanced IBC, more preferably locally advanced IBC or metastatic IBC.

10. The method according to claims 1 to 9, wherein breast cancer is triple-negative inflammatory breast cancer.

11. The method according to anyone of claims 1 to 10, wherein breast cancer is relapsed or is refractory breast cancer.

12. The method according to anyone of claims 1 to 11, wherein the subject is naive to anti-breast cancer treatments, or wherein breast cancer relapsed after at least one anti-breast cancer treatment, or after two or more anti-breast cancer treatments.

13. The method according to claim 12, wherein anti-breast cancer treatments include treatment with one or more chemotherapeutic agent, preferably anthracyclines and/or taxanes, surgery or radiotherapy.

14. The method according to anyone of claims 1 to 13, wherein said at least one chemotherapeutic agent is selected from the group consisting of: abitrexate (Methotrexate), abraxane (Paclitaxel Albumin-stabilized Nanoparticle Formulation), ado-Trastuzumab Emtansine, adrucil (Fluorouracil), afinitor (Everolimus), anastrozole, aredia (Pamidronate Disodium), arimidex

(Anastrozole), aromasin (Exemestane), carboplatin, capecitabine, cisplatin, Clafen (Cyclophosphamide), Cyclophosphamide, Cytoxan (Cyclophosphamide), Docetaxel, Doxorubicin Hydrochloride, Efudex (Fluorouracil), Ellence (Epirubicin Hydrochloride), Epirubicin Hydrochloride, Eribulin Mesylate, Everolimus, Exemestane, Fareston (Toremifene), Faslodex (Fulvestrant), Femara (Letrozole),

Fluoroplex (Fluorouracil), Fluorouracil, Folex (Methotrexate), Folex PFS (Methotrexate), Fulvestrant, Gemcitabine Hydrochloride, Gemzar (Gemcitabine Hydrochloride), Goserelin Acetate, Halaven (Eribulin Mesylate), Herceptin (Trastuzumab), Ixabepilone, Ixempra (Ixabepilone), Kadcyla (Ado-Trastuzumab Emtansine), Lapatinib Ditosylate, Letrozole, Megace (Megestrol Acetate),

Megestrol Acetate, Methotrexate, Methotrexate LPF (Methotrexate), Mexate (Methotrexate), Mexate-AQ (Methotrexate), mitoxantrone, Neosar (Cyclophosphamide), Nolvadex (Tamoxifen Citrate), Paclitaxel, Paclitaxel Albumin- stabilized Nanoparticle Formulation, Pamidronate Disodium, Perjeta

(Pertuzumab), Pertuzumab, Tamoxifen Citrate, Taxol (Paclitaxel), Taxotere (Docetaxel), Trastuzumab, Toremifene, Tykerb (Lapatinib Ditosylate), Velban (Vinblastine Sulfate), Velsar (Vinblastine Sulfate), Vinblastine Sulfate, Xeloda (Capecitabine), Zoladex (Goserelin Acetate), and Irinotecan.

15. The method according to anyone of claims 1 to 14, wherein said at least one chemotherapeutic agent is selected from anthracyclines, taxanes, platinum based chemotherapeutic agents, antimetabolites, and mixtures thereof.

16. The method according to anyone of claims 1 to 15, wherein said at least one chemotherapeutic agent is selected from anthracyclines.

17. The method according to claim 16, wherein said anthracycline is selected from the group consisting of doxorubicin, epirubicin, mitoxantrone, pixantrone, losoxantrone and daunorubicin, or any mixtures thereof, preferably is doxorubicin or mitoxantrone.

18. The method according to claim 1 to 17, wherein breast cancer is locally advanced or metastatic breast cancer, and wherein said at least one chemotherapeutic agent is an antimetabolite, an anthracycline, a taxane, a platinum based chemotherapeutic agent or any mixtures thereof, preferably selected from the group consisting of gemcitabine, carboplatin, capecitabine, doxorubicin, mitoxantrone or any mixtures thereof.

19. The method according to claim 1 to 17, wherein breast cancer is TNBC and wherein said at least one chemotherapeutic agent is an antimetabolite, an anthracycline, a taxane, a platinum based chemotherapeutic agent or any mixtures thereof, preferably selected from the group consisting of cisplatin, gemcitabine, carboplatin, doxorubicin, mitoxantrone or any combination thereof.

20. The method according to claim 1 to 17, wherein breast cancer is IBC, and wherein said at least one chemotherapeutic agent is an antimetabolite, an anthracycline, a taxane, a platinum based chemotherapeutic agent or any mixtures thereof,

preferably is selected from the group consisting of gemcitabine, capecitabine, cisplatin, carboplatin, doxorubicin, mitoxantrone or any mixtures thereof.

21. The method according to any one of claims 1 to 20, wherein the therapeutically effective amount of said c-Kit inhibitor or mast cell inhibitor ranges from about 6 mg/kg/day to about 9 mg/kg/day.

22. The method according to any one of claims 1 to 21, wherein said c-Kit inhibitor or mast cell inhibitor is orally administered.

23. A method for inhibiting tyrosine kinases, preferably selected from the group consisting of c-Kit, LYN, FYN and PDGFR a and β and for inducing an anti- tumoral Thl immune response, in a breast cancer patient, thereby treating breast cancer, wherein said method comprises administering a therapeutically effective amount of a c-Kit inhibitor or mast cell inhibitor, preferably masitinib, or a pharmaceutically acceptable salt or solvate thereof in combination with a therapeutically effective amount of a chemotherapeutic agent.

24. A pharmaceutical composition comprising a c-Kit inhibitor or mast cell inhibitor or a pharmaceutically acceptable salt or solvate thereof and a chemotherapeutic agent, in combination with at least one pharmaceutically acceptable carrier, wherein said c-Kit inhibitor is preferably masitinib mesilate, and wherein said chemotherapeutic agent is preferably selected from cisplatin, gemcitabine, carboplatin, capecitabine, doxorubicin, mitoxantrone and mixtures thereof.

25. A medicament comprising a c-Kit inhibitor or mast cell inhibitor or a pharmaceutically acceptable salt or solvate thereof and a chemotherapeutic agent, wherein said c-Kit inhibitor or mast cell inhibitor is preferably masitinib mesilate, and wherein said chemotherapeutic agent is preferably selected from cisplatin, gemcitabine, carboplatin, capecitabine, doxorubicin, mitoxantrone and mixtures thereof.

26. A kit of part comprising, in a first part, a c-Kit inhibitor or mast cell inhibitor or a pharmaceutically acceptable salt or solvate thereof, preferably wherein said c-Kit

inhibitor or mast cell inhibitor is masitinib mesilate, and, in a second part, a chemotherapeutic agent, preferably selected from cisplatin, gemcitabine, carboplatin, capecitabine, doxorubicin, mitoxantrone and mixtures thereof.

The pharmaceutical composition according to claim 24, the medicament according to claim 25 or the kit of part according to claim 26, for treating breast cancer.