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6045 : BERIL-1: Biomarker results from targeted sequencing of circulating tumor DNA (ctDNA) and archival tissue in a randomized phase II study of buparlisib (BKM120) or placebo plus paclitaxel in patients with head and neck squamous cell carcinoma (HNSCC).

Researchers

Presenter

  • Lisa F. Licitra

Principal Investigators

  • Sandrine J. Faivre

  • Marie Chol

  • Nadia Solovieff

  • Douglas Robinson

  • Emmanuelle DiTomaso

  • Samit Hirawat

  • Denis Soulieres

Medical Centers

  • Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy

  • Hopitaux Universitaires Paris Nord Val de Seine (HUPNVS), Paris, France

  • Novartis AG, Basel, Switzerland

  • Novartis Institutes for BioMedical Research, Inc, Cambridge, MA

  • Novartis Pharmaceutical Corporation, East Hanover, NJ

  • Centre Hospitalier de LUniversite de Montreal (CHUM), Montreal, QC, Canada

Locations

  • Canada

  • Italy

  • Switzerland

  • United States

  • France

Companies

  • Novartis AG

Study Components

Therapeutic Area

  • Oncology (ONC)

Disease

  • Squamous cell carcinoma of the head and neck

Biomarkers

  • Circulating DNA

Drug/Treatment

  • buparlisib

  • Paclitaxel

  • BKM-120

Outcome

  • Indeterminate

Study Design

  • Randomized

  • Placebo Control

Phase

  • II

Study Id's

  • NCT01852292

Sponsors

  • N/A

Result

  • Final

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