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A Phase II/III Randomized Trial of Veliparib or Placebo in Combination With Adjuvant Temozolomide in Newly Diagnosed Glioblastoma With MGMT Promoter Hypermethylation
Primary Objective:
Test whether the experimental combination of ABT-888 (Veliparib) combined with TMZ, compared to the control of placebo combined with TMZ, significantly extends overall survival in newly diagnosed GBM patients with tumor MGMT promoter Hypermethylation.
Secondary Objectives:
Test whether the experimental treatment significantly extends progression-free survival.
Test whether the experimental treatment improves objective tumor response.
Test whether the experimental treatment is associated with significantly greater rates of grade 3 or higher adverse events.
Correlative Science Objectives:
Evaluate the utility of dynamic susceptibility contrast (DSC) and diffusion weighted imaging (DWI) MRI techniques in defining time to progression in the setting of a large multi-institutional clinical trial.
Primary Objective:
Test whether the experimental combination of ABT-888 (Veliparib) combined with TMZ, compared to the control of placebo combined with TMZ, significantly extends overall survival in newly diagnosed GBM patients with tumor MGMT promoter Hypermethylation.
Secondary Objectives:
Test whether the experimental treatment significantly extends progression-free survival.
Test whether the experimental treatment improves objective tumor response.
Test whether the experimental treatment is associated with significantly greater rates of grade 3 or higher adverse events.
Correlative Science Objectives:
Evaluate the utility of dynamic susceptibility contrast (DSC) and diffusion weighted imaging (DWI) MRI techniques in defining time to progression in the setting of a large multi-institutional clinical trial.
Recruitment Status
Past Studies