Cabazitaxel/XRP6258 - Phase 1/2 TCD12128

• Research type

  Research Study

• Full title

  A Phase 1/2 Study of Cabazitaxel Combined with Abiraterone Acetate and Prednisone in Patients with Metastatic Castrate-Resistant Prostate Cancer (mCRPC) whose Disease has Progressed after Docetaxel Chemotherapy

• IRAS ID

  92899

• Contact name

  Johann S de Bono

• Sponsor organisation

  Sanofi

• Eudract number

  2011-001506-96

• ISRCTN Number

  not known

• Research summary

  Prostate cancer is a major worldwide health problem and is the most frequently diagnosed male malignancy after lung cancer. Worldwide, there were 903,452 new cases and 258,381 deaths due to prostate cancer alone during the year 2008. Prostate cancer is associated with extensive morbidity, as most patients experience significant pain as the result of bone metastases. Patients with advanced disease usually receive treatment with hormonal agents. However, the effect of hormonal manipulation is temporary, and most patients experience disease progression after 18 months of treatment. Although chemotherapy has historically been regarded as modestly effective for the treatment of metastatic castration resistant prostate cancer (mCRPC), recent studies have suggested that chemotherapy may be an effective treatment. Mitoxantrone became the first chemotherapy agent to be approved for the treatment of prostate cancer. Docetaxel in combination with prednisolone was then approved in 2004 and has now been adopted as standard first line therapy for MCRPC. Supportive care, with various non-approved agents with limited activity is used in this setting, palliation being the main goal therapy. Cabazitaxel (CBZ), a new semi-synthetic agent which acts by stopping cells and particularly cancer cells from dividing and growing, shows a better antiproliferative activity on laboratory resistant cell lines than docetaxel. Both CBZ and the androgen synthesis inhibitor Abiraterone (ABIa) have demonstrated an overall survival benefit in the management of mCRPC in patients who have progressed on docetaxel treatment. These drugs do not appear to have apparent overlapping toxicities. The next logical clinical question is whether the use of these agents in combination will provide any further benefit.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  12/LO/0103

• Date of REC Opinion

  27 Mar 2012

• REC opinion

  Further Information Favourable Opinion