Phase 2a study (Part 1) – A phase 2a study to evaluate the safety, pharmacokinetics and clinical activity of the PI3K/mTOR inhibitor GDC-0084 administered to patients with glioblastoma multiforme characterized by unmethylated O6-methylguaninemethyltransferase promoter status. Phase 2b study (Part 2) – A randomized, open-label, multicenter, phase 2b study to assess the efficacy and safety of the PI3K/mTOR inhibitor GDC-0084 compared to temozolomide as adjuvant therapy for the treatment of newly diagnosed glioblastoma multiforme with unmethylated O6-methylguanine-methyltransferase promoter status following surgical resection and standard concomitant chemoradiation therapy with temozolomide

Type of Cancer

Phase

Division (Location)

Study ID

NCT#

Brief Description
Phase 2a study (Part 1) – A phase 2a study to evaluate the safety, pharmacokinetics and clinical activity of the PI3K/mTOR inhibitor GDC-0084 administered to patients with glioblastoma multiforme characterized by unmethylated O6-methylguaninemethyltransferase promoter status. Phase 2b study (Part 2) – A randomized, open-label, multicenter, phase 2b study to assess the efficacy and safety of the PI3K/mTOR inhibitor GDC-0084 compared to temozolomide as adjuvant therapy for the treatment of newly diagnosed glioblastoma multiforme with unmethylated O6-methylguanine-methyltransferase promoter status following surgical resection and standard concomitant chemoradiation therapy with temozolomide

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