Phase 2 Trial of PX-866 in Patients with Glioblastoma Multiforme
Interim data from an open-label single-arm Phase 2 trial of PX-866 in patients with glioblastoma multiforme (GBM), a type of brain cancer, were presented by Marshall W. Pitz, M.D., of CancerCare Manitoba, University of Manitoba, Winnipeg, Manitoba. The Phase 2 trial is being conducted at 7 Canadian centers by the NCIC Clinical Trials Group (NCIC CTG), Queen's University in Kingston, Canada, in patients whose brain tumor is in first relapse during or following primary therapy. The trial has a two-stage design, with progression to the second stage dependent upon achieving a pre-specified endpoint of response or lack of early progression.
Seventeen patients were enrolled in the first stage of the trial and were included in this presentation. PX-866 was well-tolerated in the study, with the most common adverse events being diarrhea and reversible liver enzyme elevation. All patients were evaluable for response, with one patient having a partial response and six patients with stable disease, three of whom remained on therapy at the time of the report. These efficacy data met the pre-specified endpoint, and the trial is currently enrolling a planned additional 15 patients in the second stage.
PX-866 Phase 2 Program UpdateIn addition to the above mentioned trial in patients with GBM, the NCIC CTG is also conducting a Phase 2 trial in up to 40 patients with metastatic or recurrent castration resistant prostate cancer who have not received prior chemotherapy. The primary endpoint of this single-arm screening trial is the proportion of patients with lack of disease progression at 12 weeks from the initiation of therapy with PX-866. The trial has a two-stage design, with progression to the second stage dependent upon achieving a pre-specified endpoint of lack of early progression. The trial has completed enrollment in the first stage of the study and the interim analysis is currently pending.