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Claims for Patent: 8,927,592

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Claims for Patent: 8,927,592

Title:Antitumoral use of cabazitaxel
Abstract: The invention relates to a compound of formula: ##STR00001## which may be in base form or in the form of a hydrate or a solvate, in combination with prednisone or prednisolone, for its use as a medicament in the treatment of prostate cancer, particularly metastatic prostate cancer, especially for patients who are not catered for by a taxane-based treatment.
Inventor(s): Gupta; Sunil (Chester Springs, PA)
Assignee: Aventis Pharma SA (Antony, FR)
Application Number:13/456,720
Patent Claims: 1. A method for treating a patient with prostate cancer that has progressed during or after treatment with docetaxel, comprising administering to said patient a dose of 20 to 25 mg/m.sup.2 of cabazitaxel, or a hydrate or solvate thereof, in combination with a corticoid.

2. The method according to claim 1, where the prostate cancer is an advanced metastatic disease.

3. The method according to claim 1, where the cabazitaxel is in the form of an acetone solvate.

4. The method according to claim 3, in which the acetone solvate contains between 5% and 8% by weight of acetone.

5. The method according to claim 1, comprising repeating the administration of cabazitaxel, or hydrate or solvate thereof, as a new cycle every 3 weeks.

6. The method according to claim 1, wherein the cabazitaxel is in base form.

7. The method according to claim 1, wherein said cabazitaxel, or hydrate or solvate thereof, is administered in an amount to provide an AUC of about 991 ngh/mL (CV 34%).

8. The method according to claim 1, wherein said cabazitaxel, or hydrate or solvate thereof, is administered in an amount to provide an C.sub.max of about 226 ngh/mL (CV 107%).

9. The method according to claim 1 wherein said cabazitaxel, or hydrate or solvate thereof, is administered in an amount to provide a plasma clearance of 48.5 L/h (CV 39%).

10. The method according to claim 1, further comprising monitoring blood counts and measuring neutrophil levels in the patient.

11. The method according to claim 10, further comprising discontinuing cabazitaxel treatment in a patient with a neutrophil count of .ltoreq.1,500 cells/mm.sup.3.

12. The method according to claim 1, where the cabazitaxel, or hydrate or solvate thereof, is administered at a dose of 25 mg/m.sup.2.

13. The method according to claim 1, wherein the corticoid is selected from the group consisting of prednisone and prednisolone.

14. The method according to claim 13, where the prednisone or prednisolone is administered at a dose of 10 mg/day.

15. The method according to claim 14, where the cabazitaxel, or hydrate or solvate thereof, is administered at a dose of 20 mg/m.sup.2.

16. The method according to claim 14, where the cabazitaxel, or hydrate or solvate thereof, is administered at a dose of 25 mg/m.sup.2.

17. The method according to claim 1, where the prostate cancer is a castration resistant or hormone-refractory prostate cancer.

18. The method according to claim 17, where the cabazitaxel, or hydrate or solvate thereof, is administered at a dose of 25 mg/m.sup.2.

19. The method according to claim 17, comprising repeating the administration of said cabazitaxel, or hydrate or solvate thereof, as a new cycle every 3 weeks.

20. The method according to claim 1, wherein the prostate cancer is a castration resistant or hormone-refractory, metastatic prostate cancer.

21. The method according to claim 20, where the cabazitaxel, or hydrate or solvate thereof, is administered at a dose of 20 mg/m.sup.2.

22. The method according to claim 20, where cabazitaxel, or hydrate or solvate thereof, is administered at a dose of 25 mg/m.sup.2.

23. The method according to claim 20, comprising repeating the administration of said cabazitaxel, or hydrate or solvate thereof, as a new cycle every 3 weeks.

24. The method according to claim 1, wherein the prostate cancer is a castration resistant or hormone-refractory, metastatic prostate cancer, and wherein the corticoid is selected from the group consisting of prednisone and prednisolone, and wherein the cabazitaxel, or hydrate or solvate thereof, is administered at a dose of 25 mg/m.sup.2.

25. The method according to claim 24, comprising repeating the administration of said cabazitaxel, or hydrate or solvate thereof, as a new cycle every 3 weeks.

26. The method according to claim 1, where the cabazitaxel, or hydrate or solvate thereof, is administered at a dose of 20 mg/m.sup.2.

27. A method of increasing the survival of a patient with a castration resistant or hormone refractory, metastatic prostate cancer that has progressed during or after treatment with docetaxel, comprising administering a dose of 20 to 25 mg/m.sup.2 of cabazitaxel, or hydrate or solvate thereof, to the patient in combination with prednisone or prednisolone.

28. The method according to claim 27, where the cabazitaxel, or hydrate or solvate thereof, is administered at a dose of 25 mg/m.sup.2.

29. The method according to claim 27, comprising repeating the administration of said cabazitaxel, or hydrate or solvate thereof, as a new cycle every 3 weeks.

30. The method according to claim 27, where the cabazitaxel, or hydrate or solvate thereof, is administered at a dose of 20 mg/m.sup.2.
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