Phase III comparative study of OGX-011 in men with prostate cancer
Research type
Research Study
Full title
A Randomized Phase 3 Study Comparing Cabazitaxel/Prednisone in Combination with Custirsen (OGX-011) to Cabazitaxel/Prednisone for Second-Line Chemotherapy in Men with Metastatic Castrate Resistant Prostate Cancer
IRAS ID
106449
Contact name
Johann Sebastian De Bono
Sponsor organisation
OncoGenex Technologies Inc.
Eudract number
2012-001461-32
Clinicaltrials.gov Identifier
Research summary
Phase III comparative study of OGX-011 in men with prostate cancer. This is a randomized Phase 3 Study comparing Cabazitaxel/Prednisone in Combination with Custirsen (OGX-011) to Cabazitaxel/Prednisone alone (standard treatment) at increasing survival in patients with metastatic, castrate resistant (also known as hormone-refractory) prostate cancer. The cancer has metastatasized or spread outside the prostate area to other parts of participant's body (for e.g. bones, lungs, or abdomen). The study will also see if custirsen is safe when given with cabazitaxel and prednisone. Custirsen (OGX-011) is a new medication that is experimental. Custirsen reduces the level of a protein called clusterin. This protein can be overproduced in cancer cells and has been shown in laboratory studies to make cells stronger. This means that the cancer medications cannot work as well. The study medication may help other cancer medication (such as chemotherapy) work better. About 630 participants with castrate resistant prostate cancer will be enrolled in this research study at around 100 study centers internationally. All participants taking part in the study will receive cabazitaxel with prednisone. About 315subjects will receive custirsen. The study consists of screening visit which will take place approximately 4 weeks before the participant receive the first dose of study medication. If eligible the participants will be randomised (like flipping of a coin) to one of the two treatment groups listed below. Group A: cabazitaxel, prednisone and custirsen Or Group B: cabazitaxel and prednisone Participant may be receiving therapy until his prostate cancer is no longer responding to the study medication(s) or until he experiences unwanted reactions or has completed 10 Cycles. If the participant continues through all 10 Cycles, he will be on the study medication part of the study for about 31 weeks (7 months). If the participant's taken off study medication(s) for something other than worsening disease, he will still be seen every 6 weeks for evaluations (Off-Study Medication Follow-Up) until his disease worsens or the participant chooses not to continue with study evaluations. The participant will then be followed by his study doctor and study team every 3 months for the rest of his life to look at the long term effects of the study on survival.
REC name
London - Chelsea Research Ethics Committee
REC reference
12/LO/1027
Date of REC Opinion
12 Jul 2012
REC opinion
Favourable Opinion