OncoGenex has announced plans to begin a Phase II trial of OGX-427 in treatment-naive metastatic pancreatic cancer patients.
OGX-427 in combination with Abraxane (paclitaxel protein-bound particles for injectable suspension) and gemcitabine will be studied in the randomised, placebo-controlled trial, named Rainier.
The University of California, San Francisco, haematology / oncology division associate professor of medicine and trial primary investigator Dr Andrew Ko said that while previous trial results suggest patients with advanced pancreatic cancer are likely to receive treatment with gemcitabine plus Abraxane in the future, there is a need to improve survival times for these patients.
"The Rainier trial provides us the opportunity to explore the role of Hsp27 in pancreatic cancer, and the potential ability of OGX-427 to improve on clinical outcomes when added to combination chemotherapy," Ko said.
Around 130 patients are expected to be randomised with either OGX-427 or placebo in combination with Abraxane and gemcitabine therapy.
Overall survival is the primary endpoint of the trial, which will also assess progression-free survival (PFS), tumour response rates, safety, tolerability and the effect of therapy on heat shock protein (Hsp27) levels.
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By GlobalDataThe Sarah Cannon Research Institute (SCRI) is sponsoring the trial, which will be conducted at around 12 sites across the US.
SCRI GI Cancer Research Programme director Dr Johanna Bendell said; "We are very excited to bring this trial of an exciting novel agent to patients with metastatic pancreatic cancer, who desperately need more treatment options."