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Novel antitumoral use of cabazitaxel

A technology of cabazitaxel and compounds, applied in the field of novel anti-tumor applications, which can solve problems such as limiting treatment options

Inactive Publication Date: 2012-11-07
AVENTIS PHARMA INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] In addition, cancers can become resistant to the drugs used, especially taxanes, which limits the possible treatment options

Method used

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  • Novel antitumoral use of cabazitaxel
  • Novel antitumoral use of cabazitaxel
  • Novel antitumoral use of cabazitaxel

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0111] A clinical study was performed in which patients received treatment with cabazitaxel or a reference treatment based on mitoxantrone, each in combination with prednisone or prednisolone.

[0112] More specifically, the following patients were randomized to receive 10 mg / day prednisone + 12 mg / m 2 Mitoxantrone or 10mg / day prednisone+25mg / m 2 Of cabazitaxel, in which mitoxantrone and cabazitaxel are both administered once every 3 weeks, the patient is over 18 years old, suffering from metastatic castration-resistant metastatic prostate cancer, the prostate cancer can be passed RECIST standard to measure or not measurable, in which PSA levels increase or new lesions appear, the Eastern Cooperative Oncology Group (ECOG, Eastern Cooperative Oncology Group) physical status is 0-2 and the organ function is appropriate (patients must have neutrophils> 1,500 cells / mm 3 , Platelet> 100,000 cells / mm 3 , Hemoglobin> 10g / dL, creatinine 2 ) During or during docetaxel treatment (cumulative ...

Embodiment 2

[0161] Table 6 shows examples of dose adjustments for adverse reactions in patients treated with cabazitaxel.

[0162] Table 6

[0163]

[0164] If the patient is at a dose of 20mg / m 2 If you continue to experience any of these reactions, stop cabazitaxel treatment.

Embodiment 3

[0166] Physical state and pain score during treatment

[0167] method

[0168] -ECOG PS, pain measurement and analgesic consumption are evaluated before each treatment cycle and at the end of study treatment.

[0169] -Pain evaluation: current pain intensity (PPI) scale from the McGill-Melzack questionnaire (Melzack R. Pain 1975; 1:277-99). The average analgesic score (AS) for the week before each evaluation was calculated, which was derived from the consumption of analgesics (based on the equivalent of morphine). The area under the curve (AUC) of PPI and AS is calculated by the trapezoidal formula. For each patient, the cumulative AUC of PPI and AS is calculated to the last cycle for which data is available. From the first cycle to the tenth cycle, the average AUC of each treatment group was compared.

[0170] result

[0171] -The physical status of most patients remained stable during treatment and was similar between groups. See Figure 4 .

[0172] -Overall, the PPI scores are...

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PUM

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Abstract

The invention relates to a compound of Formula (I): 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.

Description

Technical field [0001] The present invention relates to a novel anti-tumor use of cabazitaxel in the treatment of prostate cancer, especially for patients who are not suitable for taxane-based therapy, which may be metastatic. In particular, the present invention relates to the use of cabazitaxel in the treatment of patients with metastatic prostate cancer resistant to castration who have previously used docetaxel-based regimens ( An unmet need for medication) for treatment. Background technique [0002] Prostate cancer affects a large proportion of the male population worldwide: in 2002, there were 680,000 cases worldwide; it is estimated that there will be 900,000 new cases each year as of 2010 (CA Cancer J. Clin., 2005, 55, 74-108) . It is the most common cancer that occurs in men except lung cancer. [0003] Prostate cancer is usually initially removed by androgen deprivation, that is, by surgical removal of the testicles (The Current State of Hormonal Therapy for Prostate C...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/164A61K31/56A61K45/06A61P35/00
CPCA61K31/164A61K31/573A61K31/337A61K45/06A61K31/56A61K38/193A61P13/08A61P15/00A61P25/16A61P35/00A61P35/04A61P43/00A61K2300/00
Inventor S.古普塔
Owner AVENTIS PHARMA INC
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