Spots Global Cancer Trial Database for 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
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Trial Identification
Brief Title: 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
Official Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) in Combination With Nab-Paclitaxel Plus Gemcitabine Compared With Placebo Plus Nab-Paclitaxel and Gemcitabine in Subjects With Hyaluronan-High Stage IV Previously Untreated Pancreatic Ductal Adenocarcinoma
Study ID: NCT02715804
Conditions
Study Description
Brief Summary: The purpose of this study is to compare the efficacy and safety of PEGylated Recombinant Human Hyaluronidase (PEGPH20) combined with nab-paclitaxel plus gemcitabine (PAG treatment), compared with placebo combined with nab-paclitaxel plus gemcitabine (AG treatment), in participants with hyaluronan (HA)-high Stage IV previously untreated pancreatic ductal adenocarcinoma (PDA).
Detailed Description: Participants will be randomized in a 2:1 ratio to PAG or AG treatment.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of South Alabama, Mobile, Alabama, United States
Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
Highlands Oncology Group, Fayetteville, Arkansas, United States
St. Jude Hospital Yorba DBA Linda St. Joseph Heritage Health, Fullerton, California, United States
Scripps Clinical Research Services, La Jolla, California, United States
Samuel Oschin Comprehensive Cancer Institute, Los Angeles, California, United States
David Geffen School of Medicine (DGSOM) at UCLA, Los Angeles, California, United States
Chao Family Comprehensive Cancer Center, Orange, California, United States
St. Joseph Hospital, Orange, California, United States
Desert Hematology Oncology Medical Group, Inc., Rancho Mirage, California, United States
Cancer Care Associates Medical Group, Inc., Redondo Beach, California, United States
Pacific Hematology Oncology Associates, San Francisco, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, United States
Pacific Central Coast Health Centers: San Luis Obispo Oncology and Hematology Health Center, San Luis Obispo, California, United States
St Joseph Heritage Healthcare, Santa Rosa, California, United States
Innovative Clinical Research Institution, Whittier, California, United States
Kaiser Permanente Franklin Medical Offices - Denver, Denver, Colorado, United States
US Oncology - Rocky Mountain Cancer Centers - Midtown, Denver, Colorado, United States
St. Mary's Medical Center, Grand Junction, Colorado, United States
Yale Cancer Center, New Haven, Connecticut, United States
MedStar Georgetown University Hospital, Washington, District of Columbia, United States
Memorial Healthcare System - Memorial Cancer Institute, Hollywood, Florida, United States
21st Century Oncology, Jacksonville, Florida, United States
MD Anderson Cancer Center Orlando, Orlando, Florida, United States
Fort Wayne Medical Oncology/Hematology, INC., Fort Wayne, Indiana, United States
The University Of Kansas Cancer Center, Kansas City, Kansas, United States
University of Louisville, Louisville, Kentucky, United States
Ochsner Health Center, Baton Rouge, Louisiana, United States
Ochsner Clinic CCOP, New Orleans, Louisiana, United States
The Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
UMass Memorial Medical Center, Worcester, Massachusetts, United States
University of Michigan Medical Center, Ann Arbor, Michigan, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
Virginia Piper Cancer Institute, Minneapolis, Minnesota, United States
University of Minnesota Medical School, Minneapolis, Minnesota, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
Renown Regional Medical Center, Reno, Nevada, United States
Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, United States
Saint Joseph's Ambulatory Clinic, Clifton, New Jersey, United States
Jersey Shore University Medical Center, Neptune, New Jersey, United States
Northwell Health/Monter Cancer Center, Lake Success, New York, United States
NYU Langone Medical Center - NYU Langone Arena Oncology, New Hyde Park, New York, United States
Columbia University Medical Center, New York, New York, United States
Mount Sinai School of Medicine - The Tisch Cancer Institute, New York, New York, United States
University of Rochester Medical Center, Rochester, New York, United States
Rex Cancer Center, Raleigh, North Carolina, United States
Gabrail Cancer Center Research, Canton, Ohio, United States
The University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
Allegheny General Hospital, Pittsburgh, Pennsylvania, United States
Univ of Pittsburgh Cancer institute, Pittsburgh, Pennsylvania, United States
Baylor College of Medicine - Baylor Clinic, Houston, Texas, United States
Scott and White, Temple, Texas, United States
University of Utah - Huntsman Cancer Institute, Salt Lake City, Utah, United States
Inova Dwight and Martha Schar Cancer Institute, Fairfax, Virginia, United States
Fort Belvoir Community Hospital, Fort Belvoir, Virginia, United States
Virginia Cancer Institute, Mechanicsville, Virginia, United States
Swedish Cancer Institute/ Swedish Health Services, Seattle, Washington, United States
University of Washington (UW) - Seattle Cancer Care Alliance, Seattle, Washington, United States
Northwest Medical Specialties PLLC, Tacoma, Washington, United States
University of Wisconsin Health - UW Carbone Cancer Center, Madison, Wisconsin, United States
Columbia St. Marys, Milwaukee, Wisconsin, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Bankstown-Lidcombe Hospital, Bankstown, New South Wales, Australia
Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia
St Vincent's Hospital, Darlinghurst, New South Wales, Australia
Royal North Shore Hospital, St Leonards, New South Wales, Australia
Flinders Medical Centre, Bedford, South Australia, Australia
Bendigo Health Care Group, Bendigo, Victoria, Australia
Monash Health, Bentleigh East, Victoria, Australia
Peninsula & South Eastern Haematology and Oncology Group, Frankston, Victoria, Australia
Imelda Ziekenhuis, Bonheiden, Antwerpen, Belgium
UZA, Edegem, Antwerpen, Belgium
Cliniques Universitaires Saint-Luc, Brussels, Brussels Capital Region, Belgium
Hôpital Erasme, Bruxelles, Brussels Capital Region, Belgium
AZ Maria Middelares - Campus Maria Middelares, Gent, Oost-Vlaanderen, Belgium
UZ Leuven - Campus Gasthuisberg, Leuven, Vlaams Brabant, Belgium
Centre Hospitalier Universitaire (CHU) de Liege - Domaine Un, Liege, , Belgium
CENANTRON - Centro Avançado de Tratamento Oncologico, Belo Horizonte, Minas Gerais, Brazil
Hospital da Cidade de Passo Fundo, Passo Fundo, Rio Grande Do Sul, Brazil
Hospital de Clinicas de Porto Alegre - UFRGS, Porto Alegre, Rio Grande Do Sul, Brazil
Hospital São Lucas da PUCRS, Porto Alegre, Rio Grande Do Sul, Brazil
Occ -Oncologia Clínica De Campinas, Campinas, São Paulo, Brazil
Fundação Amaral Cravalho / Hospital Amaral Carvalho, Jaú, São Paulo, Brazil
Fm Abc/ Cepho, Santo Andre, São Paulo, Brazil
Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, São Paulo, Brazil
Fundacao Pio XII Hospital De Câncer de Barretos, Barretos, , Brazil
Instituto COI, Rio de Janeiro, , Brazil
Instituto Nacional de Câncer - INCA, Rio de Janeiro, , Brazil
Royal Victoria Regional Health Centre, Barrie, Ontario, Canada
Princess Margaret Hospital, Toronto, Ontario, Canada
Klinicki bolnicki centar Zagreb, Zagreb, Grad Zagreb, Croatia
Klinicki bolnički centar Sestre milosrdnice, Zagreb, , Croatia
Masarykuv onkologicky ustav, Brno, Brno-město, Czechia
FN Hradec Kralove, Hradec Kralove, Královéhradecký Kraj, Czechia
Fakultni nemocnice Olomouc, Olomouc, Olomoucký Kraj, Czechia
Nemocnice Na Bulovce (Hospital Na Bulovce), Prague, , Czechia
Fakultni nemocnice v Motole, Praha 5, , Czechia
Odense Universitetshospital, Odense, South Denmark, Denmark
East Tallinn Central Hospital Oncology Center, Tallinn, Harjumaa, Estonia
North Estonian Medical Centre Foundation Clinic of Oncology, Tallinn, Harjumaa, Estonia
Centre Eugene Marquis, Rennes Cedex, Bretagne, France
Hospitalier Jean Minjoz, Besançon cedex, Franche-Comté, France
ICM Val d'Aurelle Saint Eloi - Departement Oncologie, Montpellier, Hérault, France
ICO - Site Ren Gauducheau, Saint Herblain, Loire-Atlantique, France
CHU Estaing, Clermont-Ferrand, Puy-de-Dôme, France
Hopital Edouard Herriot, Lyon Cedex 03, Rhône, France
Institut De Cancerologie Gustave Roussy, Villejuif, Val-de-Marne, France
Institut de Cancérologie de l'Ouest - Site Paul Papin, Angers Cedex 02, , France
Hôpital Haut-Leveque, Bordeaux, , France
Henri Mondor - Albert Chevenier, Créteil, , France
Centre Lyon Berard, Lyon Cedex, , France
Hopital Privé Jean Mermoz, Lyon, , France
Institut Mutualiste Montsouris, Paris, , France
Pitié Salpetriere Hospital, Paris, , France
Hôpital Beaujon, Clichy Cedex, Île-de-France, France
Universitätsklinikum Ulm, Ulm, Baden-Württemberg, Germany
Klinikum der Universität München - Campus Grosshadern, München, Bayern, Germany
Universitätsklinikum Bonn, Bonn, Nordrhein-Westfalen, Germany
Uniklinik Köln-Klinik für Gastroenterologie und Hepatologie am Abdominalzentrum, Koeln, Nordrhein-Westfalen, Germany
Universitätsklinik Carl-Gustav-Carus Dresden, Dresden, Sachsen, Germany
Universitätsklinikum Leipzig AöR, Leipzig, Sachsen, Germany
Charité - Universitätsmedizin Berlin, Berlin, , Germany
Kliniken Essen-Mitte Evang. Huyssens-Stiftung, Essen, , Germany
Universitätsklinikum Halle-Universitätsklinik und Poliklinik, Halle, , Germany
Facharztzentrum Eppendorf, Hamburg, , Germany
Universitätskllinikum Heidelberg, Heidelberg, , Germany
Pécsi Tudományegyetem Klinikai Központ, Pécs, Baranya, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpo, Szeged, Csongrád, Hungary
Petz Aladár Megyei Oktató Kórház, Győr, Gyor-Moson-Sopron, Hungary
Debreceni Egyetem Klinikai Központ, Debrecen, Hajdú-Bihar, Hungary
Egyesített Szent István és Szent László Kórház-Rendelőintéze, Budapest, , Hungary
Magyar Honvédség Egészségügyi Központ, Budapest, , Hungary
Országos Onkológiai Intézet, Budapest, , Hungary
Semmelweis Egyetem - Isz. Bel, Onkológiai Részleg, Budapest, , Hungary
Semmelweis Egyetem - Onkohaematológiai Osztály, Budapest, , Hungary
Szent Margit Kórház, Budapest, , Hungary
Somogy Megyei Kaposi Mór Oktató Kórház, Kaposvár, , Hungary
Assaf Harofeh Medical Center, Be'er Ya'aqov, HaMerkaz, Israel
Meir Medical Center, Kfar-Saba, HaMerkaz, Israel
Rabin Medical Center - Beilinson Hospital, Petah Tikva, HaMerkaz, Israel
Tel Aviv Sourasky Medical Center, Tel Aviv, Tel-Aviv, Israel
Hadassah Medical Organisation, Jerusalem, Yerushalayim, Israel
Ha'Emek Medical Center, Afula, , Israel
Soroka Medical Center [Oncology], Beer Sheva, , Israel
Hillel Yaffe Medical Center, Hadera, , Israel
Rambam Health Care Campus, Haifa, , Israel
Shaare Zedek Medical Center, Jerusalem, , Israel
The Chaim Sheba Medical Center [Oncology], Tel Hashomer, , Israel
U.O. di Oncologia, San Giovanni Rotondo, Foggia, Italy
Istituto Clinico Humanitas Rozzano, IRCCS, Rozzano, Milano, Italy
PO di Cremona, ASST di Cremona, Cremona, , Italy
AO S. Martino, IRCCS, IST-Istituto Nazionale Ricerca Sul Cancro, Genova, , Italy
IRCCS Ospedale S.Raffaele, Milano, , Italy
Ieo, Irccs, Milan, , Italy
Istituto Oncologico Veneto IOV-IRCCS, Padova, , Italy
Regina Elena, Istituto Nazionale dei Tumori, IFO, IRCCS, Roma, , Italy
Borgo Roma, Policlinico G.Rossi, AOU Integrata Verona, Verona, , Italy
Dong-A University Hospital, Busan, Busan Gwang'yeogsi, Korea, Republic of
Keimyung University Dongsan Medical Center, Daegu, Daegu Gwang'yeogsi, Korea, Republic of
Seoul National University Bundang Hospital, Seongnam, Gyeonggido, Korea, Republic of
Asan Medical Center, Seoul, Seoul Teugbyeolsi, Korea, Republic of
Korea University Anam Hospital, Seoul, Seoul Teugbyeolsi, Korea, Republic of
Samsung Medical Center, Seoul, Seoul Teugbyeolsi, Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, Seoul Teugbyeolsi, Korea, Republic of
The Catholic University of Korea, Seoul St.Mary's Hospital, Seoul, Seoul Teugbyeolsi, Korea, Republic of
Gachon University Gil Medical Center, Incheon, , Korea, Republic of
Korea University Guro Hospital, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Daugavpils Regional Hospital, Daugavpils, , Latvia
P.Stradins Clinical University, Riga, , Latvia
SIA "Rigas Austrumu Kliniska Universitates Slimnica", Riga, , Latvia
National Cancer Institute, Vilnius, Vilniaus Apskritis, Lithuania
Vilniaus Universiteto ligonines Santariskiu Klinikos, Vilnius, Vilniaus Apskritis, Lithuania
Maastricht University Medical Centre, Maastricht, Limburg, Netherlands
Academisch Medisch Centrum Universiteit van Amsterdam, Amsterdam, , Netherlands
Spaarne Gasthuis, Hoofddorp, , Netherlands
Radboud Universiteit Nijmegen, Nijmegen, , Netherlands
Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onko, Brzozow, Podkarpackie, Poland
Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie, Lublin, , Poland
Centrum Onkologii Instytut im. M. Sklodowskiej-Curie, Warszawa, , Poland
Institut Català d'Oncologia-Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain
Institut Catalá d´Oncología (I.C.O.), L'Hospitalet De Llobregat, Barcelona, Spain
H.U. de Fuenlabrada, Fuenlabrada, Madrid, Spain
Clínica Universidad de Navarra, Pamplona, Navarra, Spain
H.del Mar, Barcelona, , Spain
H.Sta.Creu i St.Pau, Barcelona, , Spain
H.U.Vall d'Hebrón, Barcelona, , Spain
H.C. S.Carlos, Madrid, , Spain
H.G.U. G. Marañón, Madrid, , Spain
H.U. F. Jiménez Díaz, Madrid, , Spain
H.U. R. y Cajal, Madrid, , Spain
Hospital Madrid Norte Sanchinarro, Madrid, , Spain
F.I. Valenciano de Oncología, Valencia, , Spain
Hospital Universitari i Politècnic La Fe, Valencia, , Spain
H.U. Miguel Servet, Zaragoza, , Spain
China Medical University Hospital, Taichung, Taichung Municipality, Taiwan
Changhua Christian Hospital, Changhua, , Taiwan
National Cheng Kung University Hospital, Tainan, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Veterans General Hospital- Taipei, Taipei, , Taiwan
Addenbrooke's Hospital, Cambridge, Cambridge, Cambridgeshire, United Kingdom
Peterborough And Stamford Hospitals, Peterborough, Cambridgeshire, United Kingdom
Beatson West of Scotland Cancer Centre, Glasgow, Glasgow City, United Kingdom
Sarah Cannon Research Institute UK (SCRI UK), London, London, City Of, United Kingdom
Edinburgh Cancer Centre Western General Hospital, Edinburgh, Midlothian, United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust, Birkenhead, Wirral, United Kingdom
Queen Elizabeth Hospital Birmingham, Birmingham, , United Kingdom
Castle Hill Hospital, Cottingham, , United Kingdom
Coventry Hospital, Coventry, , United Kingdom
Hammersmith Hospital, London, , United Kingdom
The Royal Marsden NHS Foundation - Sutton, London, , United Kingdom
The Royal Marsden NHS Foundation Trust - Chelsea, London, , United Kingdom
North Wales Cancer Treatment Centre, Rhyl, , United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust, Wirral, , United Kingdom
The Christie NHS Foundation Trust, Withington, , United Kingdom
Contact Details
Name: VP, Medical, Regulatory and Drug Safety
Affiliation: Halozyme Therapeutics
Role: STUDY_DIRECTOR
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