Clinical Trials Search
Clinical Trial 18308
Interventions:Placebo; Temodal (Temozolomide); Temozolomide; Veliparib (ABT-888)
Study Type: Treatment
Phase of Study: Phase II/III
- Peter Forsyth
A Phase II/III Randomized Trial of Veliparib or Placebo in Combination with Adjuvant Temozolomide in Newly Diagnosed Glioblastoma with MGMT Promoter Hypermethylation
The purpose of this study is to find out if an investigational drug called veliparib can help people whose brain tumors show a change in a small region of DNA (gene).
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. -Test the concordance between site-determined MGMT methylation status and central laboratory determination of MGMT status in cases with local testing. -Evaluate whether genetic or epigenetic alterations in DNA repair or replication genes are associated with overall survival, progression-free survival, and objective tumor response. -Test whether polymorphisms in MGMT, PARP1, or other DNA repair proteins, are associated with overall survival, progression-free survival, objective tumor response, or rates of grade 3 or higher adverse events.