Cabazitaxel Expanded Access Program for mHRPC patients

• Research type

  Research Study

• Full title

  Multicentre, single-arm, open label clinical trial intended to provide early access to cabazitaxel in patients with metastatic hormone refractory prostate cancer previously treated with a docetaxel-containing regimen.

• IRAS ID

  53690

• Contact name

  Johann de Bono

• Sponsor organisation

  Aventis Pharma Ltd trading as sanofi-aventis

• Eudract number

  2010-021128-92

• ISRCTN Number

  N/A

• Research summary

  Prostate cancer is the most frequently diagnosed male cancer. Patients with very early prostate cancer may be treated with surgery or radiotherapy to try and stop the cancer from spreading. If the cancer spreads locally or around the prostate patients can receive hormonal therapy. When a patients?? cancer no longer responds to the hormones their illness is known as hormone refractory. The treatment option for these patients is to take chemotherapy to kill the cancer cells. When patients are treated with chemotherapy, the first treatment they receive is a drug called docetaxel. It is common that after a while some cancer cells will develop resistance to docetaxel and will continue to grow and make more drug resistant cells that docetaxel can not kill. These patients have a very poor prognosis with approximately 6-12 months survival. At present there is no approved standard second line therapy. Treatment options include supportive care or palliation (therapy to relieve pain symptoms) these do not provide an increase in long term survival. Therefore there is a need for new therapeutic agents in this setting.Cabazitaxel has demonstrated significant increase in overall survival of patients with docetaxel resistant disease. Cabazitaxel has been submitted for license in the US and Europe for this group of patients. The main aim of this study is to allow patients and physicians access to cabazitaxel for the treatment of metastatic prostate cancer prior to license. In addition the study aims to collect further safety data and essential quality of life data in these patients. The safety data will be used to demonstrate the manageable side effects of cabazitaxel already documented in earlier trials. The quality of life data will be used to assess the impact that Cabazitaxel has on the patients?? daily activities and support the cabazitaxel NICE appraisal in 2011.

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  10/H0715/58

• Date of REC Opinion

  11 Nov 2010

• REC opinion

  Further Information Favourable Opinion