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4126 : Updated overall survival (OS) analysis of NAPOLI-1: Phase 3 study of nanoliposomal irinotecan (nal-IRI, MM-398), with or without 5-fluorouracil and leucovorin (5-FU/LV), vs 5-FU/LV in metastatic pancreatic cancer (mPAC) previously treated with gemcitabine (gem)-based therapy.

Researchers

Presenter

  • Andrea Wang-Gillam

Principal Investigators

  • Gyorgy Bodoky

  • Andrew Dean

  • Yang-Shen Shan

  • Gayle S. Jameson

  • Teresa Macarulla

  • Kyung-Hun Lee

  • David Cunningham

  • Jean-Frederic Blanc

  • Richard Hubner

  • Chang-Fang Chiu

  • Gilberto Schwartsmann

  • Jens T Siveke

  • Fadi S. Braiteh

  • Victor M. Moyo

  • Bruce Belanger

  • Eliel Bayever

  • Daniel D. Von Hoff

  • Li-Tzong Chen

Medical Centers

  • Siteman Cancer Center, Washington University, Saint Louis, MO

  • St. Laszlo Teaching Hospital, Budapest, Hungary

  • St. John of God Hospital, Subiaco, Australia

  • National Institute of Cancer Research, National Health Institutes and National Cheng Kung University Hospital, Tainan, Taiwan

  • TGen and Banner Health, Scottsdale, AZ

  • Vall d Hebron University Hospital (HUVH) and Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain

  • Royal Marsden Hospital, Surrey, United Kingdom

  • Hopital Saint-Andre, Bordeaux, France

  • The Christie NHS Foundation TRUST, Manchester, United Kingdom

  • China Medical University Hospital, Taichung, Taiwan

  • Hospital De Clinicas de Porto Alegre, Porto Alegre RS, Brazil

  • Klinikum rechts der Isar der TU Muenchen, Munich, Germany

  • Comprehensive Cancer Centers of Nevada, Las Vegas, NV

  • Merrimack Pharmaceuticals, Cambridge, MA

  • National Health Research Institutes (NHRI) - National Institute of Cancer Research, Taipei, Taiwan

Locations

  • Brazil

  • Taiwan

  • Spain

  • Germany

  • United Kingdom

  • Australia

  • United States

  • France

  • Hungary

Companies

  • N/A

Study Components

Therapeutic Area

  • Oncology (ONC)

  • Gastroenterology (GU)

Disease

  • Metastatic pancreatic adenocarcinoma

Biomarkers

  • N/A

Drug/Treatment

  • 5-fluorouracil + leucovorin

  • Irinotecan

  • Adrucil injection

  • Fluorouracil

  • Gemcitabine

  • leucovorin

  • Irinotecan sucrosofate

Outcome

  • Positive

Study Design

  • Randomized

Phase

  • III

Study Id's

  • NCT01494506

Sponsors

  • N/A

Result

  • Final

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