OncoGenex Pharmaceuticals and Teva Pharmaceutical Industries have just announced the initiation of a new, randomized, controlled, global Phase III trial to evaluate the effectiveness and safety of custirsen ( OGX-011) as first-line therapy for the treatment of metastatic, castration-resistant prostate cancer (mCRPC).
According to a report on TheStreet.com, the SYNERGY trial is the second of three Phase III trials that OncoGenex and Teva have agreed to implement under a collaborative agreement to develop and commercialize custirsen. The trial will be conducted in about 800 men with mCRPC who have disease progression and require first-line chemotherapy with docetaxel + prednisone. Patients will be randomized to receive treatment with either docetaxel + prednisone + custirsen or with docetaxel + prednisone alone. This trial will involve about 125 participating clinical trial sites.
The primary endpoint of the trial is overall survival. In other words, the investigators want to know whether the addition of custisen to docetaxel + prednisone actually increases the overall survival of patients compared to docetaxel + prednisone alone. Additional information about the SYNERGY study can be found on the ClinicalTrials.gov web site.
Another study, started earlier this year (the SATURN trial), is designed to compare docetaxel + prednisone + custirsen to docetaxel + prednisone alone in men with mCRPC who have already received prior treatment with docetaxel + prednisone — but who have subsequently shown indications of a rising PSA and progressive disease.
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