OncoGenex Pharmaceuticals Inc. has announced the start of its “PACIFIC” study. PACIFIC is an investigator-sponsored, randomized Phase 2 study that will evaluate OGX-427 in men with metastatic castrate-resistant prostate cancer (CRPC) who have a rising PSA while they are receiving Zytiga (abiraterone acetate). The study will determine if adding OGX-427 to Zytiga treatment can reverse or delay treatment resistance.
Approximately 80 men who are being treated with Zytiga and have a rising PSA, but no evidence of symptomatic or radiographic progression, will be randomized to either continue treatment with Zytiga and prednisone alone, or have OGX-427 added to the Zytiga and prednisone treatment. Patients will be stratified based on whether they have received prior chemotherapy and will continue on study until symptomatic, radiographic or other documented disease progression occurs. The primary objective will be to compare the two treatment groups for delaying further disease progression while on Zytiga by assessing the progression-free survival (PFS) rate at 60 days after adding OGX-427. Secondary objectives include comparing the treatment arms for PSA responses, objective responses, time to progression, circulating tumor cells (CTCs) and other biomarkers.
“The rationale for PACIFIC is based on the idea that resistance to treatment is caused by cancer cells using adaptive pathways to escape and proliferate,” said Scott Cormack, president and CEO of OncoGenex Pharmaceuticals. “OGX-427 and Zytiga are potentially synergistic because they disrupt androgen receptor signaling in different ways. We believe that by adding OGX-427 to Zytiga in patients who are experiencing a rising PSA we may be able to reverse treatment resistance and extend the benefits of Zytiga.”
PACIFIC will be conducted at approximately 15 sites in the US and Canada and is being managed by the Hoosier Oncology Group. Dr. Kim Chi from the British Columbia Cancer Agency, Dr. Christopher Sweeney from the Dana Farber Cancer Institute and Dr. Noah Hahn from the Indiana University Simon Cancer Center, will serve as the primary investigators on the study. Dr Noah Hahn is also the Chief Scientific Officer for the Hoosier Oncology Group.
For more information, go to: http://oncogenex.com/.