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A Phase 2 Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of the PI3K/mTOR Inhibitor Paxalisib (GDC-0084) Administered to Patients With Glioblastoma Characterized by Unmethylated O6-methylguanine-methyltransferase Promoter Status Following Surgical Resection and Standard Concomitant Chemoradiation Therapy With Temozolomide

Trial Profile

A Phase 2 Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of the PI3K/mTOR Inhibitor Paxalisib (GDC-0084) Administered to Patients With Glioblastoma Characterized by Unmethylated O6-methylguanine-methyltransferase Promoter Status Following Surgical Resection and Standard Concomitant Chemoradiation Therapy With Temozolomide

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 26 Mar 2025

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At a glance

  • Drugs Paxalisib (Primary)
  • Indications Astrocytoma; Glioblastoma
  • Focus Adverse reactions
  • Acronyms GBM-AGILE
  • Sponsors Kazia Therapeutics

Most Recent Events

  • 31 Dec 2024 Results presented in a Kazia Therapeutics media release
  • 31 Dec 2024 According to a Kazia Therapeutics media release, today provided a regulatory update on paxalisib for the treatment of glioblastoma (GBM) following its Type C clinical meeting with the United States Food and Drug Administration (FDA).
  • 04 Nov 2024 According to a Kazia Therapeutics media release, Full data including secondary endpoints from the paxalisib arm of this study is expected to be presented at a scientific meeting later this year

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