According to a media release from OncoGenex Pharmaceuticals earlier today, the company has started to enroll patients in a second, randomized, Phase III clinical trial of custirsen (OGX-011), this time in combination with second-line chemotherapy.
The so-called AFFINITY trial will evaluate the effectiveness and safety of custirsen + carbazitaxel + prednisone in comparison to carbazitaxel + prednisone alone in men with men with metastatic, castrate-resistant prostate cancer (mCRPC) who have already progressed after initial treatment with docetaxel-based chemotherapy. The primary endpoint for the trial will be overall survival. Secondary analyses will be carried out to evaluate any effects on disease progression and quality of life factors.
More detailed data on the structure of the AFFINITY trial, patient eligibility criteria, and centers that are participating in this trial are now available on the ClinicalTrials.gov web site and on an OncoGenex-sponsored web site. Only one center (in California) is listed as enrolling patients as of today, but the proposed trial enrollment is 630 patients, and so we can safely assume that other centers will also start to enroll patients in the near future.
Note that the AFFINITY trial is not a double-blind study. Physicians and patients will know up front which patients are being treated with custirsen in addition to cabazitaxel and prednisone.
The earlier Phase III SYNERGY study, which was designed to evaluate the combination of docetaxel + prednisone + custirsen as compared to docetaxel + prednisone + a placebo as a first-line chemotherapy for men with CRPC, is also still accruing patients. Patient accrual for the SYNERGY trial is expected to be completed before the end of 2012.