Antitumoral use of cabazitaxel

• US 10,716,777 B2
• Filed: 01/15/2020
• Issued: 07/21/2020
• Est. Priority Date: 10/29/2009
• Status: Active Grant

• Current Assignee: Sanofi Mature IP
• Original Assignee: Sanofi Mature IP
• Inventors: Gupta, Sunil
• Primary Examiner(s): Anderson, James D.
• Application Number:
  US16/743,411
• Publication Number:
  US 20200155497A1
• Time in Patent Office: 188 Days
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/164 of a carboxylic acid with an aminoalcohol, e.g. ceramides
• CPC Class Codes: A61K 31/337 having four-membered rings, e.g. taxol
• CPC Class Codes: A61K 31/56 Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
• CPC Class Codes: A61K 31/573 substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
• CPC Class Codes: A61K 38/193 Colony stimulating factors [CSF]
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61P 13/08 of the prostate
• CPC Class Codes: A61P 15/00 Drugs for genital or sexual disorders for disorders of sex hormones A61P5/24; Contraceptives
• CPC Class Codes: A61P 25/16 Anti-Parkinson drugs
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 35/04 specific for metastasis
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

The invention relates to a compound of formula:

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.

Claims

1. A method of increasing survival comprising administering to a patient in need thereof a dose of 20 to 25 mg/m² of cabazitaxel, or a hydrate or solvate thereof, in combination with an H₂ antagonist, wherein the H₂ antagonist is administered to the patient prior to administering the dose of cabazitaxel, and wherein said patient has castration resistant metastatic prostate cancer that has progressed during or after treatment with docetaxel.

2. The method of claim 1, where the cabazitaxel, or hydrate or solvate thereof, is administered at a dose of 20 mg/m².

3. The method of claim 1, where the cabazitaxel, or hydrate or solvate thereof, is administered at a dose of 25 mg/m².

4. The method of claim 1, where the H₂ antagonist is administered at least 30 minutes prior to administering the dose of cabazitaxel.

5. The method of claim 4, where the cabazitaxel, or hydrate or solvate thereof, is administered at a dose of 20 mg/m².

6. The method of claim 4, where the cabazitaxel, or hydrate or solvate thereof, is administered at a dose of 25 mg/m².