This is an adaptive design, randomized controlled, Phase 3 clinical trial in patients with
glioblastoma multiforme (GBM) or gliosarcoma (GS), previously treated with surgery (if
appropriate), standard of care chemo-radiation with temozolomide, +/- adjuvant temozolomide,
and bevacizumab and now has progressive disease during or after bevacizumab.
For Patients With Recurrent Glioblastoma Who Have Failed Standard Temozolomide/Radiation Therapy and Bevacizumab (STAR-3): More Information
A total of up to 180 eligible patients with recurrent/progressive GBM or GS will be
randomized to receive either the investigational drug (VAL-083) or "Investigator's choice of
salvage therapy" as a contemporaneous control, in a 2:1 fashion. Up to 120 eligible patients
will be randomized to receive VAL-083 at 40 mg/m2 IV on days 1, 2, and 3 of a 21-day
treatment-cycle, for up to 12, 21-day treatment cycles or until they fulfill one of the
criteria for study discontinuation. Up to 60 patients will be randomized to receive
"Investigator's choice of salvage therapy", limited to temozolomide, lomustine, or
carboplatin, until they fulfill one of the criteria for study discontinuation. The dose level
for Investigator's choice salvage therapy (temozolomide, lomustine, or carboplatin), will be
in accordance with the product label or institutional guidelines.
In both study arms, interval medical histories, targeted physical exams, neurologic
evaluations, complete blood counts, and other laboratory and safety assessments will be
performed approximately every 21-days while receiving treatment. Tumor assessments are to be
performed approximately every 42 ± 7 days while remaining on study. The study is estimated to
last approximately 20 months.