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6008 : BERIL-1: A phase II, placebo-controlled study of buparlisib (BKM120) plus paclitaxel in patients with platinum-pretreated recurrent/metastatic head and neck squamous cell carcinoma (SCCHN).

Researchers

Presenter

  • Denis Soulieres

Principal Investigators

  • Ricard Mesia

  • Eva Remenar

  • Shau-Hsuan Li

  • Andrey Karpenko

  • Arunee Dechaphunkul

  • Ulrich Keilholz

  • Laura Anna Kiss

  • Jin-Ching Lin

  • Rajnish Vasant Nagarkar

  • Laszlo Tamas

  • Sung-Bae Kim

  • Jozsef Erfan

  • Sabine Turri

  • Debarshi Dey

  • Arunava Chakravartty

  • Paola Aimone

  • Cristian Massacesi

  • Lisa F. Licitra

Medical Centers

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

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

  • Medical Oncology Department, Institut Catala d'Oncologia (ICO) L'Hospitalet, University of Barcelona, Barcelona, Spain

  • Orszagos Onkologiai Intezet, Budapest, Hungary

  • Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan

  • Leningrad Regional Oncology Dispensary, Saint Petersburg, Russia

  • Charite Comprehensive Cancer Center, Berlin, Germany

  • Szent Imre University Teaching Hospital, Budapest, Hungary

  • Taichung Veterans General Hospital, Taichung City, Taiwan

  • Curie Manavata Cancer Center, Nashik, India

  • Semmelweis University, Budapest, Hungary

  • Josa Andras Teaching Hospital, Nyiregyhaza, Hungary

  • Novartis Pharma, Paris, France

  • Novartis Healthcare Pvt. Ltd, Hyderabad, India

  • Novartis AG, Basel, Switzerland

  • Novartis Oncology, Paris, France

  • Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy

Locations

  • Canada

  • Taiwan

  • Italy

  • Spain

  • Germany

  • Switzerland

  • Thailand

  • France

  • Russia

  • India

  • Hungary

Companies

  • Novartis AG

Study Components

Therapeutic Area

  • Oncology (ONC)

Disease

  • Squamous cell carcinoma of the head and neck

Biomarkers

  • N/A

Drug/Treatment

  • buparlisib

  • Paclitaxel

  • BKM-120

Outcome

  • Indeterminate


Study Design

  • Randomized

  • Placebo Control

  • Controlled

Phase

  • II

Study Id's

  • NCT01852292

Sponsors

  • N/A

Result

  • Final