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638 : HALO 109-301: A randomized, double-blind, placebo-controlled, phase 3 study of pegvorhyaluronidase alfa (PEGPH20) + nab-paclitaxel/gemcitabine (AG) in patients (pts) with previously untreated hyaluronan (HA)-high metastatic pancreatic ductal adenocarcinoma (mPDA).

Researchers

Presenter

  • Margaret A. Tempero

Principal Investigators

  • Darren Sigal

  • Do-Youn Oh

  • Nicola Fazio

  • Teresa Macarulla

  • Erika Hitre

  • Pascal Hammel

  • Andrew Eugene Hendifar

  • Susan Elaine Bates

  • Chung-Pin Li

  • Christelle De La Fouchardiere

  • Volker Heinemann

  • Anthony Maraveyas

  • Nathan Bahary

  • Laura Layos

  • Vaibhav Sahai

  • Lei Zheng

  • Jill Lacy

  • Andrea J. Bullock

Medical Centers

  • Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, CA

  • University Hospitals Leuven and KU Leuven, Leuven, Belgium

  • Scripps Clinic Cancer Center, La Jolla, CA

  • European Institute of Oncology, Milan, Italy

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

  • National Institute of Oncology, Budapest, Hungary

  • Hopital Beaujon (AP-HP), Clichy, and University Paris VII, Paris, France

  • Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai, Los Angeles, CA

  • Columbia University Medical Center, New York, NY

  • Leon-Berard Cancer Centre, Lyon, France

  • Department of Internal Medicine III and Comprehensive Cancer Center, Klinikum Grosshadern, Ludwig-Maximilians University of Munich, Munich, Germany

  • Joint Centre for Cancer Studies, Hull York Medical School, Castle Hill Hospital, Cottingham, Hull, United Kingdom

  • NRG Oncology, and UPMC Hillman Cancer Center, University of Pittsburgh School of Medicine, Pittsburgh, PA

  • Institut Catala d'Oncologia, Hospital Universitario German Trias i Pujol, Badalona, Spain

  • University of Michigan, Ann Arbor, MI

  • Johns Hopkins University, Baltimore, MD

  • Smilow Cancer Hospital at Yale University, New Haven, CT

  • Beth Israel Deaconess Medical Center, Boston, MA

Locations

  • United States

  • Belgium

  • Italy

  • Spain

  • Hungary

  • France

  • Taiwan

  • Germany

  • United Kingdom

  • Republic of South Korea

Companies

  • N/A

Study Components

Therapeutic Area

  • Pulmonary/Respiratory Diseases

  • Cardiovascular (CVS)

  • Oncology (ONC)

  • Blood/haematological Diseases

Disease

  • Pancreas ductal adenocarcinoma

  • Venous thrombosis

Biomarkers

  • N/A

Drug/Treatment

  • Gemcitabine

  • Enoxaparin

  • Enoxaparin sodium

  • Hyaluronic acid

  • Paclitaxel

  • PEGPH20

Outcome

  • N/A

Study Design

  • Randomized

  • Placebo Control

  • Double Blind/Blinded

  • Controlled

Phase

  • III

Study Id's

  • NCT02715804

Sponsors

  • N/A

Result

  • N/A

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