novogenbuyer, good find and reasoning. It is an opportune time for Kazia to incorporate COVID-19 into our GBM AGILE platform design strategy for the study, if possible. Edison extract 13 January 2020. "The Glioblastoma (GBM) Adaptive Global Innovative Learning Environment (GBM AGILE, NCT03970447) trial is an adaptive Phase II/III platform designed to evaluate multiple therapies against one rolling control group; it currently has 11 US centers and plans to add leading international centers to its network. It is a clinician-led trial with an FDA-agreed single Master Clinical Trial Application. On entering the study, the newly diagnosed GBM AGILE patients undergo surgery to remove the tumor followed by radiation therapy combined with temozolomide (TMZ) (Stupp regimen). The difference tested is overall survival in the randomized maintenance phase using either TMZ or GDC-0084. AGILE uses a stage 1, which recruits up to 150 patients to assess efficacy compared against patients with a similar profile in the control arm. If this stage appears positive, up to 50 patients might be recruited to a stage 2 expansion cohort for confirmatory data. Currently, the kinase inhibitor regorafenib (Stivarga, Bayer), approved for advanced gastrointestinal cancers but not GBM, is being tested. AGILE has several advantages: a faster start, an existing design and an expanding infrastructure plus involvement of key opinion leaders, a big benefit in the event of positive data, regulatory review and launch. However, Kazia will not have direct control over the study, so any problems or delays might take longer to resolve."
Regards.
KZA Price at posting:
38.0¢ Sentiment: Buy Disclosure: Held
