Oncothyreon Inc. (ONTY: Quote) announced the initiation of a Phase 1/2 trial of PX-866 in combination with vemurafenib or Zelboraf. PX-866 is Oncothyreon's investigational small molecule compound designed to inhibit the activity of phosphatidylinositol-3-kinase (PI-3K), a component of an important cell survival signaling pathway.
Vemurafenib is a kinase inhibitor indicated for the treatment of unresectable or metastatic melanoma with the BRAFV600E mutation.
The Phase 1 portion of this trial will evaluate the safety and tolerability of PX-866 in combination with twice daily oral administration of vemurafenib in up to 36 patients with any BRAF-mutant cancer.
The company said that the trial will use a dose-escalation design to evaluate up to three dose levels of PX-866 with up to two dose levels of vemurafenib to determine the maximally tolerated or recommended dose of both PX-866 and vemurafenib to be used in Phase 2.
The company noted that the Phase 2 portion of the trial will compare the anti-tumor activity and safety of PX-866 and vemurafenib at the doses recommended from Phase 1 with vemurafenib alone administered at the approved dose. This randomized Phase 2 trial is expected to enroll 110 patients with advanced BRAF-mutant melanoma and has a primary endpoint of progression-free survival.
This Phase 1/2 trial is being conducted in collaboration with the Melanoma Research Foundation Breakthrough Consortium or MRFBC.
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by RTT Staff Writer
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