GBM AGILE

rroodd

You ask some good questions which are ridiculed and ignored
Agile trial discussions

Hasn't the past 2 years of trials determined efficacy ?????

Agile trial
Up front costs ??
ongoing costs ??
Assess efficacy ??
Control over data and trial ???
Time frame for first 150 patients to assess efficacy and then if positive efficacy another 50 patients recruited etc...

''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.''

DYOR