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news.Keryx Biopharmaceuticals (Keryx) has reached agreement with the FDA regarding a Special Protocol Assessment (SPA) on the design of a Phase 3 trial for its PI3K/Akt pathway inhibitor, KRX-0401 (perifosine), in patients with refractory metastatic colorectal cancer. The SPA provides agreement that the Phase 3 study design adequately addresses objectives in support of a regulatory submission.
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The company said that the Phase 3 X-PECT (Xeloda + Perifosine Evaluation in Colorectal cancer Treatment) trial will be a randomised (1:1), double-blind trial comparing the efficacy and safety of perifosine + capecitabine (capecitabine is a chemotherapy marketed by Roche as Xeloda) vs placebo + capecitabine in approximately 430 patients with refractory metastatic colorectal cancer.
Reportedly, the primary endpoint is overall survival (OS), with secondary endpoints including overall response rate, progression-free survival (PFS) and safety. The median OS for the X-PECT study’s targeted patient population, that has failed prior therapies as described above, is approximately 5 months.
The X-PECT study will be powered at 90% to detect difference in OS, with an assumed median OS for the control arm of 5-6 months and 7-8 months for the perifosine arm. Approximately 360 events of death will trigger the un-blinding of the study. The study is expected to begin in 2Q 2010, and enrollment is expected to take approximately 12 months, with study completion expected in 2H 2011.
Ron Bentsur, CEO of Keryx, said: “This SPA represents another important milestone for the company, and we wish to thank the FDA for their guidance and support in this process. We also wish to thank the Phase 2 investigators and the experts that helped us obtain this SPA. We are very encouraged by the colon Phase 2 data that was recently announced, which showed survival advantage in a refractory metastatic patient population.
“This is a very exciting time for Keryx, as we have transitioned into a late-stage development company with two drugs in Phase 3 pursuing three indications under SPAs. We eagerly await the commencement of the X-PECT study within a few months.”
Perifosine is currently in a Phase 3 trial, under Special Protocol Assessment (SPA), for the treatment of relapsed/refractory multiple myeloma, with Orphan Drug Status and Fast Track Designation granted.