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: NAPOLI-3: A randomized, open-label phase 3 study of liposomal irinotecan + 5-fluorouracil/leucovorin + oxaliplatin (NALIRIFOX) versus nab-paclitaxel + gemcitabine in treatment-naïve patients with metastatic pancreatic ductal adenocarcinoma (mPDAC).

Researchers

Presenter

  • Zev A. Wainberg

Principal Investigators

  • Teresa Macarulla

  • Roberto Pazo-Cid

  • Sreenivasa R Chandana

  • Christelle De La Fouchardiere

  • Andrew Peter Dean

  • Igor Kiss

  • Woojin Lee

  • Thorsten Oliver Goetze

  • Eric Van Cutsem

  • Andrew Scott Paulson

  • Tanios S. Bekaii-Saab

  • Shubham Pant

  • Richard Hubner

  • Zhimin Xiao

  • Huanyu Chen

  • Fawzi Benzaghou

  • Eileen Mary O'Reilly

Medical Centers

  • Investigational Cancer Therapeutics Clinical Unit, Azienda Ospedaliera Universitaria Integrata, Verona, Italy

  • University of Leuven, KUL, Leuven, Belgium

  • INSERM, Paris, France

  • The University of Texas MD Anderson Cancer Canter, Houston, TX

  • H. Universitario Miguel Servet, Zaragoza, Spain

  • Mayo Clinic Cancer Center, Scottsdale, AZ

  • Western Michigan Cancer Center, Kalamazoo, MI

  • Texas Oncology, Dallas, TX

  • Memorial Sloan Kettering Cancer Center, Port Washington, NY

  • Medical Oncology Department, Centre Leon Berard, Lyon I University, Lyon, France

  • Ipsen, Cambridge, MA

  • UCLA Medical Ctr, Santa Monica, Santa Monica, CA

  • St. John of God Hospital, Subiaco, Australia

  • Masarykuv Onkologicky Ustav, Brno, Czech Republic

  • Institut für Klinische Krebsforschung IKF am Krankenhaus Nordwest, and Krankenhaus Nordwest, University Cancer Center, Frankfurt, Germany

  • Center for Breast Cancer, National Cancer Center, Goyang, Gyeonggi-do, Korea

  • Medical Oncology Department, Breast Cancer Group, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain

  • Medical Oncology Department, The Christie NHS Foundation Trust, Manchester, United Kingdom

Locations

  • United Kingdom

  • Australia

  • United States

  • Czech Republic

  • Republic of South Korea

  • Belgium

  • Italy

  • Germany

  • Spain

  • France

Companies

  • N/A

Study Components

Therapeutic Area

  • Oncology (ONC)

Disease

  • Pancreas ductal adenocarcinoma

  • Secondary liver cancer

  • Microphthalmia, syndromic, 9

Biomarkers

  • N/A

Drug/Treatment

  • 5-fluorouracil + leucovorin

  • Irinotecan

  • Adrucil injection

  • Fluorouracil

  • Gemcitabine

  • Oxaliplatin

  • leucovorin

  • Paclitaxel

Outcome

  • N/A

Study Design

  • Randomized

  • Open Label

Phase

  • III

Study Id's

  • NCT02551991

  • NCT04083235

Sponsors

  • Ipsen

Result

  • N/A

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