OGX-011-10 Revised
Research type
Research Study
Full title
A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study Evaluating the Clinical Benefit of Adding Custirsen to Docetaxel Retreatment/Prednisone as an Option for Second-line Therapy in Men with Castrate Resistant Prostate Cancer
IRAS ID
74599
Contact name
Johann De-Bono
Sponsor organisation
Oncogenex Pharmaceuticals
Eudract number
2010-020802-13
Clinicaltrials.gov Identifier
Research summary
Normal cells in the body die at the end of their lives, however cancer cells refuse to die and keep dividing. Docetaxel is the chemotherapy used in prostate cancer to try and kill the cancer cells. The time it takes for patients?? disease to start to grow or spread again after receiving a course of docetaxel is about 6 months on average. These patients are often well enough to receive a second course of chemotherapy, but the benefits of a second course are not clear, so this is not currently given as routine treatment. Pain is one of the main symptoms for patients with Castrate Resistant Prostate Cancer (prostate cancer that grows regardless of low testosterone levels). This research study will look at whether treatment with custirsen (the study drug) in combination with a second course of docetaxel and prednisolone (a steroid drug taken daily as a tablet) can improve overall pain levels in participants. Eligible participants will be assigned at random to receive either docetaxel and prednisolone in combination with custirsen, or docetaxel and prednisolone in combination with placebo (a dummy drug). Participants will be required to attend the clinic every week for the infusion of custirsen or placebo, and every 3 weeks for the docetaxel infusion for up to 30 weeks in total. Following treatment, participants will be followed-up by the study team. During clinic visits, assessments will be performed including vital signs (blood pressure, pulse, temperature), physical examination, blood sampling, and a CT or MRI and a bone scan. Participants will also be telephoned by a contact centre on a number of occasions during screening and during each 21-day cycle to provide details of their pain and analgesic (pain medication) use. This study is sponsored by Oncogenex Pharmaceuticals. Approximately 292 patients will be enrolled worldwide.
REC name
London - City & East Research Ethics Committee
REC reference
10/H0703/108
Date of REC Opinion
26 Apr 2011
REC opinion
Further Information Favourable Opinion