OGX-011-11
Research type
Research Study
Full title
A Randomized Phase 3 Study Comparing Standard First-Line Docetaxel/Prednisone to Docetaxel/Prednisone in Combination with Custirsen (OGX-011) in Men with Metastatic Castrate Resistant Prostate Cancer
IRAS ID
62139
Contact name
johann de-bono
Eudract number
2010-021011-16
Clinicaltrials.gov Identifier
Research summary
Normal cells in the body die at the end of their life cycle. Cancer cells refuse to die and keep dividing. Docetaxel is the chemotherapy used in prostate cancer. This chemotherapy kills the cancer cells together with healthy cells. Unfortunately the time to disease progression after receiving docetaxel is about 6 months. This study is investigating a protein (Custirsen or OGX-011) that can cause cancer cell death and can delay disease progression.Eligible participants will be randomly assigned to receive either Docetaxel/Prednisolone (Arm B) or Docetaxel/Prednisolone in combination with Custirsen (Arm A).Participants on arm A will be required to attend the clinic every week for the infusion of Custirsen and Docetaxel. Patients on Arm B will be required to attend clinic every 3 weeks to receive the infusion of Docetaxel alone. A safety follow-up visit will be performed 21 days after the last dose and participants will be required to attend clinic every 4 weeks until disease progression. Participants will be contacted for long term follow-up every 12 weeks.During clinic visits, assessments will be performed including vital signs, physical examination, blood sampling, and a CT or MRI and a bone scan. Participants will be asked to complete questionnaires about their pain and other quality of life measures at certain visits.This study is sponsored by Teva Pharmaceuticals Ltd. Approximately 800 patients will be enrolled worldwide.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
10/H0505/112
Date of REC Opinion
21 Jan 2011
REC opinion
Further Information Favourable Opinion