DelMar completes first visit for pivotal Phase 3 Study in Temozolomide-Avastin
DelMar Pharmaceuticals announced the completion of the first site initiation visit at the Dent Neurological Institute for its pivotal Phase 3 Study in Temozolomide-Avastin, or bevacizumab, Recurrent GBM. Site initiation visits are generally the final step before patient enrollment. The STAR-3 GBM trial is an adaptive design, randomized, controlled pivotal Phase 3 clinical trial to assess the efficacy and safety of VAL-083 versus salvage therapy in patients with late-stage glioblastoma multiforme whose disease has progressed following prior treatment with temozolomide and bevacizumab, for whom there is currently no standard-of-care therapy. The primary endpoint of the trial is overall survival of VAL-083 vs. the control arm. The statistical design between the two arms of the study is 90% power, and is proposed to include an interim analysis at 50% events for futility with O'Brien-Fleming superiority boundary and non-binding, gamma futility boundary.