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Double Blind, Placebo Controlled Study Assessing the Efficacy of Buparlisib (BKM120) Plus Paclitaxel Versus Placebo Plus Paclitaxel in Patients With Platinum Pre-treated Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)

Trial Profile

Double Blind, Placebo Controlled Study Assessing the Efficacy of Buparlisib (BKM120) Plus Paclitaxel Versus Placebo Plus Paclitaxel in Patients With Platinum Pre-treated Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)

Status: Discontinued
Phase of Trial: Phase II

Latest Information Update: 08 Dec 2023

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At a glance

  • Drugs Buparlisib (Primary) ; Paclitaxel
  • Indications Head and neck cancer; Squamous cell cancer
  • Focus Therapeutic Use
  • Acronyms BERIL-1
  • Sponsors Novartis Pharmaceuticals
  • Most Recent Events

    • 24 Oct 2023 Results (n=145) assessing a novel methodology to identify subjects that could derive benefit from Buparlisib treatment in metastatic SCCHN patients. The analysis was focused on image analysis of H&E images to select features associated with improved clinical benefit from paclitaxel+buparlisib presented at the 48th European Society for Medical Oncology Congress
    • 06 Jun 2023 Results evaluating hierarchically prognostic and predictive biomarkers to select predefined analysis in the current Phase 3 clinical trial, BURAN (NCT04338399) post immune modulatory therapy, presented at the 59th Annual Meeting of the American Society of Clinical Oncology.
    • 30 Jul 2018 According to an Adlai Nortye media release, results from this study were published in the Clinical Cancer Research, June 2018.
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