A Study of PEGylated Recombinant Human Hyaluronidase in Combination With Nab-Paclitaxel Plus Gemcitabine Compared With Placebo Plus Nab-Paclitaxel and Gemcitabine in Participants With Hyaluronan-High Stage IV Previously Untreated Pancreatic Ductal Adenocarcinoma

PHASE3TerminatedINTERVENTIONAL
Enrollment

492

Participants

Timeline

Start Date

March 14, 2016

Primary Completion Date

November 4, 2019

Study Completion Date

November 4, 2019

Conditions
Pancreatic Ductal Carcinoma
Interventions
OTHER

Biological: PEGylated Recombinant Human Hyaluronidase (PEGPH20)

PEGPH20 will be administered as per the dose and schedule specified in the respective arms.

DRUG

Placebo

Matching placebo for PEGPH20

DRUG

nab-Paclitaxel

Nab-paclitaxel will be administered as per the dose and schedule specified in the respective arms.

DRUG

Gemcitabine

Gemcitabine will be administered as per the dose and schedule specified in the respective arms.

Trial Locations (217)

1200

Cliniques Universitaires Saint-Luc, Brussels

10016

NYU Langone Medical Center - NYU Langone Arena Oncology, New Hyde Park

10019

Columbia University Medical Center, New York

10029

Mount Sinai School of Medicine - The Tisch Cancer Institute, New York

11042

Northwell Health/Monter Cancer Center, Lake Success

14642

University of Rochester Medical Center, Rochester

15212

Allegheny General Hospital, Pittsburgh

15232

Univ of Pittsburgh Cancer institute, Pittsburgh

17033

Penn State Milton S. Hershey Medical Center, Hershey

20007

MedStar Georgetown University Hospital, Washington D.C.

21224

The Sidney Kimmel Comprehensive Cancer Center, Baltimore

22031

Inova Dwight and Martha Schar Cancer Institute, Fairfax

22060

Fort Belvoir Community Hospital, Fort Belvoir

23116

Virginia Cancer Institute, Mechanicsville

27607

Rex Cancer Center, Raleigh

32207

21st Century Oncology, Jacksonville

32806

MD Anderson Cancer Center Orlando, Orlando

33021

Memorial Healthcare System - Memorial Cancer Institute, Hollywood

36604

University of South Alabama, Mobile

40292

University of Louisville, Louisville

44718

Gabrail Cancer Center Research, Canton

46845

Fort Wayne Medical Oncology/Hematology, INC., Fort Wayne

48109

University of Michigan Medical Center, Ann Arbor

48201

Karmanos Cancer Institute, Detroit

53211

Columbia St. Marys, Milwaukee

53226

Medical College of Wisconsin, Milwaukee

53792

University of Wisconsin Health - UW Carbone Cancer Center, Madison

55404

Virginia Piper Cancer Institute, Minneapolis

55455

University of Minnesota Medical School, Minneapolis

66160

The University Of Kansas Cancer Center, Kansas City

70119

Ochsner Clinic CCOP, New Orleans

70809

Ochsner Health Center, Baton Rouge

72703

Highlands Oncology Group, Fayetteville

73104

The University of Oklahoma Health Sciences Center, Oklahoma City

76508

Scott and White, Temple

77030

Baylor College of Medicine - Baylor Clinic, Houston

80205

Kaiser Permanente Franklin Medical Offices - Denver, Denver

80218

US Oncology - Rocky Mountain Cancer Centers - Midtown, Denver

81501

St. Mary's Medical Center, Grand Junction

84103

University of Utah - Huntsman Cancer Institute, Salt Lake City

89169

Comprehensive Cancer Centers of Nevada, Las Vegas

89502

Renown Regional Medical Center, Reno

90048

Samuel Oschin Comprehensive Cancer Institute, Los Angeles

90095

David Geffen School of Medicine (DGSOM) at UCLA, Los Angeles

90277

Cancer Care Associates Medical Group, Inc., Redondo Beach

90603

Innovative Clinical Research Institution, Whittier

92037

Scripps Clinical Research Services, La Jolla

92270

Desert Hematology Oncology Medical Group, Inc., Rancho Mirage

92868

Chao Family Comprehensive Cancer Center, Orange

St. Joseph Hospital, Orange

92886

St. Jude Hospital Yorba DBA Linda St. Joseph Heritage Health, Fullerton

93401

Pacific Central Coast Health Centers: San Luis Obispo Oncology and Hematology Health Center, San Luis Obispo

94115

Pacific Hematology Oncology Associates, San Francisco

UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco

95405

St Joseph Heritage Healthcare, Santa Rosa

98104

Swedish Cancer Institute/ Swedish Health Services, Seattle

98195

University of Washington (UW) - Seattle Cancer Care Alliance, Seattle

98405

Northwest Medical Specialties PLLC, Tacoma

85234-2165

Banner MD Anderson Cancer Center, Gilbert

06510

Yale Cancer Center, New Haven

02215

Beth Israel Deaconess Medical Center, Boston

01605

UMass Memorial Medical Center, Worcester

03743

Dartmouth Hitchcock Medical Center, Lebanon

07013

Saint Joseph's Ambulatory Clinic, Clifton

07753

Jersey Shore University Medical Center, Neptune City

Unknown

Bankstown-Lidcombe Hospital, Bankstown

Chris O'Brien Lifehouse, Camperdown

St Vincent's Hospital, Darlinghurst

Royal North Shore Hospital, St Leonards

Flinders Medical Centre, Bedford

Bendigo Health Care Group, Bendigo

Monash Health, Bentleigh East

Peninsula & South Eastern Haematology and Oncology Group, Frankston

Imelda Ziekenhuis, Bonheiden

UZA, Edegem

Hôpital Erasme, Brussels

AZ Maria Middelares - Campus Maria Middelares, Ghent

UZ Leuven - Campus Gasthuisberg, Leuven

Centre Hospitalier Universitaire (CHU) de Liege - Domaine Un, Liège

CENANTRON - Centro Avançado de Tratamento Oncologico, Belo Horizonte

Hospital da Cidade de Passo Fundo, Passo Fundo

Hospital de Clinicas de Porto Alegre - UFRGS, Porto Alegre

Hospital São Lucas da PUCRS, Porto Alegre

Occ -Oncologia Clínica De Campinas, Campinas

Fundação Amaral Cravalho / Hospital Amaral Carvalho, Jaú

Fm Abc/ Cepho, Santo André

Faculdade de Medicina da Universidade de Sao Paulo, São Paulo

Fundacao Pio XII Hospital De Câncer de Barretos, Barretos

Instituto COI, Rio de Janeiro

Instituto Nacional de Câncer - INCA, Rio de Janeiro

Royal Victoria Regional Health Centre, Barrie

Princess Margaret Hospital, Toronto

Klinicki bolnicki centar Zagreb, Zagreb

Klinicki bolnički centar Sestre milosrdnice, Zagreb

Masarykuv onkologicky ustav, Brno

FN Hradec Kralove, Hradec Králové

Fakultni nemocnice Olomouc, Olomouc

Fakultni nemocnice v Motole, Prague

Nemocnice Na Bulovce (Hospital Na Bulovce), Prague

Odense Universitetshospital, Odense

East Tallinn Central Hospital Oncology Center, Tallinn

North Estonian Medical Centre Foundation Clinic of Oncology, Tallinn

Centre Eugene Marquis, Rennes

Hospitalier Jean Minjoz, Besançon

ICM Val d'Aurelle Saint Eloi - Departement Oncologie, Montpellier

ICO - Site Ren Gauducheau, Saint-Herblain

CHU Estaing, Clermont-Ferrand

Hopital Edouard Herriot, Lyon

Institut De Cancerologie Gustave Roussy, Villejuif

Institut de Cancérologie de l'Ouest - Site Paul Papin, Angers

Hôpital Haut-Leveque, Bordeaux

Henri Mondor - Albert Chevenier, Créteil

Centre Lyon Berard, Lyon

Hopital Privé Jean Mermoz, Lyon

Institut Mutualiste Montsouris, Paris

Pitié Salpetriere Hospital, Paris

Hôpital Beaujon, Clichy

Universitätsklinikum Ulm, Ulm

Klinikum der Universität München - Campus Grosshadern, München

Universitätsklinikum Bonn, Bonn

Uniklinik Köln-Klinik für Gastroenterologie und Hepatologie am Abdominalzentrum, Cologne

Universitätsklinik Carl-Gustav-Carus Dresden, Dresden

Universitätsklinikum Leipzig AöR, Leipzig

Charité - Universitätsmedizin Berlin, Berlin

Kliniken Essen-Mitte Evang. Huyssens-Stiftung, Essen

Universitätsklinikum Halle-Universitätsklinik und Poliklinik, Halle

Facharztzentrum Eppendorf, Hamburg

Universitätskllinikum Heidelberg, Heidelberg

Pécsi Tudományegyetem Klinikai Központ, Pécs

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpo, Szeged

Petz Aladár Megyei Oktató Kórház, Győr

Debreceni Egyetem Klinikai Központ, Debrecen

Egyesített Szent István és Szent László Kórház-Rendelőintéze, Budapest

Magyar Honvédség Egészségügyi Központ, Budapest

Országos Onkológiai Intézet, Budapest

Semmelweis Egyetem - Isz. Bel, Onkológiai Részleg, Budapest

Semmelweis Egyetem - Onkohaematológiai Osztály, Budapest

Szent Margit Kórház, Budapest

Somogy Megyei Kaposi Mór Oktató Kórház, Kaposvár

Assaf Harofeh Medical Center, Be’er Ya‘aqov

Meir Medical Center, Kfar Saba

Rabin Medical Center - Beilinson Hospital, Petah Tikva

Hadassah Medical Organisation, Jerusalem

Tel Aviv Sourasky Medical Center, Tel Aviv

Ha'Emek Medical Center, Afula

Soroka Medical Center [Oncology], Beersheba

Hillel Yaffe Medical Center, Hadera

Rambam Health Care Campus, Haifa

Shaare Zedek Medical Center, Jerusalem

The Chaim Sheba Medical Center [Oncology], Tel Litwinsky

U.O. di Oncologia, San Giovanni Rotondo

Istituto Clinico Humanitas Rozzano, IRCCS, Rozzano

PO di Cremona, ASST di Cremona, Cremona

AO S. Martino, IRCCS, IST-Istituto Nazionale Ricerca Sul Cancro, Genova

Ieo, Irccs, Milan

IRCCS Ospedale S.Raffaele, Milan

Istituto Oncologico Veneto IOV-IRCCS, Padua

Regina Elena, Istituto Nazionale dei Tumori, IFO, IRCCS, Roma

Borgo Roma, Policlinico G.Rossi, AOU Integrata Verona, Verona

Daugavpils Regional Hospital, Daugavpils

P.Stradins Clinical University, Riga

"SIA Rigas Austrumu Kliniska Universitates Slimnica", Riga

National Cancer Institute, Vilnius

Vilniaus Universiteto ligonines Santariskiu Klinikos, Vilnius

Maastricht University Medical Centre, Maastricht

Academisch Medisch Centrum Universiteit van Amsterdam, Amsterdam

Spaarne Gasthuis, Hoofddorp

Radboud Universiteit Nijmegen, Nijmegen

Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onko, Brzozów

Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie, Lublin

Centrum Onkologii Instytut im. M. Sklodowskiej-Curie, Warsaw

Dong-A University Hospital, Busan

Keimyung University Dongsan Medical Center, Daegu

Seoul National University Bundang Hospital, Seongnam

Asan Medical Center, Seoul

Korea University Anam Hospital, Seoul

Samsung Medical Center, Seoul

Severance Hospital, Yonsei University Health System, Seoul

The Catholic University of Korea, Seoul St.Mary's Hospital, Seoul

Gachon University Gil Medical Center, Incheon

Korea University Guro Hospital, Seoul

Seoul National University Hospital, Seoul

Institut Català d'Oncologia-Hospital Germans Trias i Pujol, Badalona

Institut Catalá d´Oncología (I.C.O.), L'Hospitalet de Llobregat

H.U. de Fuenlabrada, Fuenlabrada

Clínica Universidad de Navarra, Pamplona

H.del Mar, Barcelona

H.Sta.Creu i St.Pau, Barcelona

H.U.Vall d'Hebrón, Barcelona

H.C. S.Carlos, Madrid

H.G.U. G. Marañón, Madrid

H.U. F. Jiménez Díaz, Madrid

H.U. R. y Cajal, Madrid

Hospital Madrid Norte Sanchinarro, Madrid

F.I. Valenciano de Oncología, Valencia

Hospital Universitari i Politècnic La Fe, Valencia

H.U. Miguel Servet, Zaragoza

China Medical University Hospital, Taichung

Changhua Christian Hospital, Changhua

National Cheng Kung University Hospital, Tainan City

National Taiwan University Hospital, Taipei

Veterans General Hospital- Taipei, Taipei

Addenbrooke's Hospital, Cambridge, Cambridge

Peterborough And Stamford Hospitals, Peterborough

Beatson West of Scotland Cancer Centre, Glasgow

Sarah Cannon Research Institute UK (SCRI UK), London

Edinburgh Cancer Centre Western General Hospital, Edinburgh

The Clatterbridge Cancer Centre NHS Foundation Trust, Birkenhead

Queen Elizabeth Hospital Birmingham, Birmingham

Castle Hill Hospital, Cottingham

Coventry Hospital, Coventry

Hammersmith Hospital, London

The Royal Marsden NHS Foundation - Sutton, London

The Royal Marsden NHS Foundation Trust - Chelsea, London

The Clatterbridge Cancer Centre NHS Foundation Trust, Metropolitan Borough of Wirral

North Wales Cancer Treatment Centre, Rhyl

The Christie NHS Foundation Trust, Withington

Sponsors
All Listed Sponsors
lead

Halozyme Therapeutics

INDUSTRY