Clinical Trial Details

NCT ID: NCT02715804
Date Last Changed: September 29, 2017

Overview

Research Study Summary

Patients are needed to participate in a clinical research study of Biological: PEGylated Recombinant Human Hyaluronidase (PEGPH20), Placebo, Nab-paclitaxel and Gemcitabine to evaluate Pancreatic Ductal Adenocarcinoma

Research Study 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 Participants With Hyaluronan-High Stage IV Previously Untreated Pancreatic Ductal Adenocarcinoma

Purpose

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). Participants will be randomized in a 2:1 ratio to PAG or AG treatment.

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Recruitment Details

Phase
3
Gender
All
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
Halozyme Therapeutics
Duration
32 Months
Facility Type
N/A
Compensation

Eligibility

All ages 18 Years and up

  1. Signed, written Institutional Review Board/Ethics Committee-approved Informed Consent Form (ICF).

  2. Stage IV pancreatic ductal adenocarcinoma (PDA) with histological confirmation of PDA via archived or fresh core biopsy of either the primary tumor or 1 metastatic site.

  3. Participants must be determined to be hyaluronan-high based on tumor biopsy that meets the requirements noted in the previous inclusion criterion.

  4. At least 1 tumor metastasis measurable on computed tomography (CT) scan and/or magnetic resonance imaging (MRI) per the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria, excluding the primary pancreatic lesion.

  5. If a participant has had adjuvant/neoadjuvant therapy and/or therapy for locally advanced disease (chemotherapy for non-metastatic pancreatic cancer in combination with or without radiation therapy), tumor recurrence or disease progression must have occurred no sooner than 6 months after completing the last dose of the aforementioned therapies, provided all toxicities have returned to baseline or ≤ Grade 1.

  6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

Exclusion criteria:

  1. Clinical evidence of deep vein thrombosis (DVT), pulmonary embolism (PE) or other known thromboembolic (TE) event present during the screening period.

  2. Previous radiotherapy, surgery, chemotherapy, or investigational therapy for the treatment of metastatic disease.

a. Palliative radiotherapy for pain control of metastatic bone lesions is allowed.

  1. Known central nervous system involvement or brain metastases.

  2. New York Heart Association Class III or IV cardiac disease or myocardial infarction within the past 12 months.

  3. History of cerebrovascular accident or transient ischemic attack.

  4. Clinically significant pre-existing carotid artery disease.

Site Locations (203)

Country State City Zip Facility and Contact
United States Alabama Mobile University of South Alabama
United States Arizona Gilbert Banner MD Anderson Cancer Center
United States Arkansas Fayetteville Highlands Oncology Group
United States California Fullerton St. Jude Hospital Yorba DBA Linda St. Joseph Heritage Health
United States California La Jolla Scripps Clinical Research Services
United States California Long Beach Long Beach Memorial Medical Center
United States California Los Angeles David Geffen School of Medicine (DGSOM) at UCLA
United States California Los Angeles Samuel Oschin Comprehensive Cancer Institute
United States California Orange Chao Family Comprehensive Cancer Center
United States California Orange St. Joseph Hospital
United States California Rancho Mirage Desert Hematology Oncology Medical Group, Inc.
United States California San Francisco Pacific Hematology Oncology Associates
United States California San Francisco UCSF Helen Diller Family Comprehensive Cancer Center
United States California Santa Rosa St Joseph Heritage Healthcare
United States California Whittier Innovative Clinical Research Institution
United States Colorado Denver Kaiser Permanente Franklin Medical Offices - Denver
United States Colorado Denver US Oncology - Rocky Mountain Cancer Centers - Midtown
United States Colorado Grand Junction St. Mary's Medical Center
United States Connecticut Stamford Stamford Hospital - Carl and Dorothy Bennett Cancer Center
United States Florida Jacksonville 21st Century Oncology
United States Indiana Fort Wayne Fort Wayne Medical Oncology/Hematology, INC.
United States Louisiana Baton Rouge Ochsner Health Center
United States Louisiana New Orleans Ochsner Clinic CCOP
United States Massachusetts Boston Beth Israel Deaconess Medical Center
United States Massachusetts Worcester UMass Memorial Medical Center
United States Michigan Ann Arbor University of Michigan Medical Center
United States Michigan Detroit Karmanos Cancer Institute
United States Minnesota Minneapolis University of Minnesota Medical School
United States Minnesota Minneapolis Virginia Piper Cancer Institute
United States Nevada Las Vegas Comprehensive Cancer Centers of Nevada
United States Nevada Reno Renown Regional Medical Center
United States New Jersey Clifton Saint Joseph's Ambulatory Clinic
United States New Jersey Ridgewood Valley Health System - The Valley Hospital (TVH)
United States New York Lake Success Northwell Health/Monter Cancer Center
United States New York New York Columbia University Medical Center
United States New York New York Mount Sinai School of Medicine - The Tisch Cancer Institute
United States New York Rochester University of Rochester Medical Center
United States North Carolina Raleigh Rex Cancer Center
United States Ohio Canton Gabrail Cancer Center Research
United States Oklahoma Oklahoma City The University of Oklahoma Health Sciences Center
United States Pennsylvania Hershey Penn State Milton S. Hershey Medical Center
United States Pennsylvania Pittsburgh Allegheny General Hospital
United States Pennsylvania Pittsburgh Univ of Pittsburgh Cancer institute
United States Texas Houston Baylor College of Medicine - Baylor Clinic
United States Texas Temple Scott and White
United States Utah Salt Lake City University of Utah - Huntsman Cancer Institute
United States Virginia Fairfax Inova Dwight and Martha Schar Cancer Institute
United States Virginia Fort Belvoir Fort Belvoir Community Hospital
United States Virginia Mechanicsville Virginia Cancer Institute
United States Washington Seattle Swedish Cancer Institute/ Swedish Health Services
United States Washington Seattle University of Washington (UW) - Seattle Cancer Care Alliance
United States Washington Tacoma Northwest Medical Specialties PLLC
United States Wisconsin Madison University of Wisconsin Health - UW Carbone Cancer Center
United States Wisconsin Milwaukee Columbia St. Marys
United States Wisconsin Milwaukee Medical College of Wisconsin
Australia New South Wales Bankstown Bankstown-Lidcombe Hospital
Australia New South Wales Camperdown Chris O'Brien Lifehouse
Australia New South Wales St Leonards Royal North Shore Hospital
Australia South Australia Adelaide Royal Adelaide Hospital
Australia South Australia Bedford Flinders Medical Centre
Australia Victoria Bendigo Bendigo Health Care Group
Australia Victoria Bentleigh East Monash Health
Australia Victoria Frankston Peninsula & South Eastern Haematology and Oncology Group
Belgium Antwerpen Bonheiden Imelda Ziekenhuis
Belgium Antwerpen Edegem UZA
Belgium Brussels Capital Region Bruxelles Hôpital Erasme
Belgium Oost-Vlaanderen Gent AZ Maria Middelares - Campus Maria Middelares
Belgium Vlaams Brabant Leuven UZ Leuven - Campus Gasthuisberg
Belgium Liege Centre Hospitalier Universitaire (CHU) de Liege - Domaine Un
Brazil Minas Gerais Belo Horizonte CENANTRON - Centro Avançado de Tratamento Oncologico
Brazil Rio Grande do Sul Passo Fundo Hospital da Cidade de Passo Fundo
Brazil Rio Grande do Sul Porto Alegre Hospital de Clinicas de Porto Alegre - UFRGS
Brazil Rio Grande do Sul Porto Alegre Hospital São Lucas da PUCRS
Brazil São Paulo Jaú Fundação Amaral Cravalho / Hospital Amaral Carvalho
Brazil São Paulo Santo Andre Fm Abc/ Cepho
Brazil São Paulo Sao Paulo Faculdade de Medicina da Universidade de Sao Paulo
Brazil Barretos Fundacao Pio XII Hospital De Câncer de Barretos
Brazil Rio de Janeiro Instituto COI
Brazil Rio de Janeiro Instituto Nacional de Câncer - INCA
Canada Ontario Barrie Royal Victoria Regional Health Centre
Canada Ontario Toronto Princess Margaret Hospital
Canada Quebec Montreal CHUM St-Luc Hospital
Croatia Grad Zagreb Zagreb Klinicki bolnicki centar Zagreb
Croatia Istarska županija Pula Opca bolnica Pula
Croatia Primorsko-goranska županija Rijeka Klinicki bolnicki centar Rijeka
Croatia Zagreb Klinicki bolnički centar Sestre milosrdnice
Czechia Brno-město Brno Masarykuv onkologicky ustav
Czechia Královéhradecký kraj Hradec Kralove FN Hradec Kralove
Czechia Olomoucký kraj Olomouc Fakultni nemocnice Olomouc
Czechia Praha 5 Fakultni nemocnice v Motole
Denmark Central Jutland Herning Regionshospitalet Herning (Herning Centralsygehus)
Denmark South Denmark Odense Odense Universitetshospital
Denmark Herlev Herlev Hospital
Estonia Harjumaa Tallinn East Tallinn Central Hospital Oncology Center
Estonia Harjumaa Tallinn North Estonian Medical Centre Foundation Clinic of Oncology
Estonia Tartumaa Tartu Tartu University Hospital
France Bretagne Rennes Cedex Centre Eugene Marquis
France Franche-Comté Besançon cedex Hospitalier Jean Minjoz
France Hérault Montpellier ICM Val d'Aurelle Saint Eloi - Departement Oncologie
France Loire-Atlantique Saint Herblain ICO - Site Ren Gauducheau
France Puy-de-Dôme Clermont-Ferrand CHU Estaing
France Rhône Lyon Cedex 03 Hopital Edouard Herriot
France Val-de-Marne Villejuif Institut De Cancerologie Gustave Roussy
France Angers Cedex 02 Institut de Cancérologie de l'Ouest - Site Paul Papin
France Bordeaux Hôpital Haut-Leveque
France Créteil Henri Mondor - Albert Chevenier
France Lyon Cedex Centre Lyon Berard
France Lyon Hopital Privé Jean Mermoz
France Paris Institut Mutualiste Montsouris
France Paris Pitié Salpetriere Hospital
France Toulouse Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital
France Île-de-France Clichy Cedex Hôpital Beaujon
Hungary Baranya Pécs Pécsi Tudományegyetem Klinikai Központ
Hungary Csongrád Szeged Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpo
Hungary Gyor-Moson-Sopron Győr Petz Aladár Megyei Oktató Kórház
Hungary Hajdú-Bihar Debrecen Debreceni Egyetem Klinikai Központ
Hungary Jász-Nagykun-Szolnok Szolnok Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz - Rendeloint
Hungary Budapest Egyesített Szent István és Szent László Kórház-Rendelőintéze
Hungary Budapest Magyar Honvédség Egészségügyi Központ
Hungary Budapest Országos Onkológiai Intézet
Hungary Budapest Semmelweis Egyetem
Hungary Budapest Szent Margit Kórház
Hungary Kaposvár Somogy Megyei Kaposi Mór Oktató Kórház
Israel HaMerkaz Beer Yaacov Assaf Harofeh Medical Center
Israel HaMerkaz Kfar-Saba Meir Medical Center
Israel HaMerkaz Petah Tikva Rabin Medical Center - Beilinson Hospital
Israel Tel-Aviv Tel Aviv Tel Aviv Sourasky Medical Center
Israel Yerushalayim Jerusalem Hadassah Medical Organisation
Israel Afula Ha'Emek Medical Center
Israel Beer Sheva Soroka Medical Center [Oncology]
Israel Hadera Hillel Yaffe Medical Center
Israel Haifa Rambam Health Care Campus
Israel Jerusalem Shaare Zedek Medical Center
Israel Nahariyya Galilee Medical Center
Israel Tel Hashomer The Chaim Sheba Medical Center [Oncology]
Italy Milano Rozzano Istituto Clinico Humanitas Rozzano, IRCCS
Italy Pordenone Aviano CRO, IRCCS, Istituto Nazionale Tumori
Italy Bologna Policlinico S.Orsola Malpighi, AOU di Bologna
Italy Cremona PO di Cremona, ASST di Cremona
Italy Genova AO S. Martino, IRCCS, IST-Istituto Nazionale Ricerca Sul Cancro
Italy Milano IRCCS Ospedale S.Raffaele
Italy Milan Ieo, Irccs
Italy Padova Istituto Oncologico Veneto IOV-IRCCS
Italy Roma Azienda Complesso Ospedaliero San Filippo Neri
Italy Roma Regina Elena, Istituto Nazionale dei Tumori, IFO, IRCCS
Italy Verona Borgo Roma, Policlinico G.Rossi, AOU Integrata Verona
Korea, Republic of Busan Gwang'yeogsi Busan Dong-A University Hospital
Korea, Republic of Daegu Gwang'yeogsi Daegu Keimyung University Dongsan Medical Center
Korea, Republic of Gyeonggido Seongnam Seoul National University Bundang Hospital
Korea, Republic of Seoul Teugbyeolsi Seoul Asan Medical Center
Korea, Republic of Seoul Teugbyeolsi Seoul Korea University Anam Hospital
Korea, Republic of Seoul Teugbyeolsi Seoul Samsung Medical Center
Korea, Republic of Seoul Teugbyeolsi Seoul Severance Hospital, Yonsei University Health System
Korea, Republic of Seoul Teugbyeolsi Seoul The Catholic University of Korea, Seoul St.Mary's Hospital
Korea, Republic of Incheon Gachon University Gil Medical Center
Korea, Republic of Seoul Korea University Guro Hospital
Korea, Republic of Seoul Seoul National University Hospital
Latvia Daugavpils Daugavpils Regional Hospital
Latvia Liepaja Liepaja Regional Hospital
Latvia Riga P.Stradins Clinical University
Latvia Riga SIA "Rigas Austrumu Kliniska Universitates Slimnica"
Lithuania Kauno Apskritis Kaunas Hospital of Lithuanian University of Health Sciences
Lithuania Vilniaus Apskritis Vilnius National Cancer Institute
Lithuania Vilniaus Apskritis Vilnius Vilniaus Universiteto ligonines Santariskiu Klinikos
Netherlands Amsterdam Academisch Medisch Centrum Universiteit van Amsterdam
Netherlands Limburg Maastricht Univeersity Medical Centre
Netherlands Nijmegen Radboud Universiteit Nijmegen
Poland Mazowieckie Warszawa MAGODENT Sp. z o.o. Szpital Onkologiczno-Kardiologiczny
Poland Podkarpackie Brzozow Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onko
Poland Pomorskie Gdansk COPERNICUS Podmiot Leczn. Sp z o.o.,Wojew. Centrum Onkologii
Poland Lublin Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
Poland Warszawa Centrum Onkologii Instytut im. M. Sklodowskiej-Curie
Spain Barcelona Badalona Institut Català d'Oncologia-Hospital Germans Trias i Pujol
Spain Barcelona L'Hospitalet De Llobregat Institut Catalá d´Oncología (I.C.O.)
Spain Madrid Fuenlabrada H.U. de Fuenlabrada
Spain Navarra Pamplona Clínica Universidad de Navarra
Spain Valenciana, Comunidad Valencia H.C.U.Valencia
Spain Barcelona H.del Mar
Spain Barcelona H.Sta.Creu i St.Pau
Spain Barcelona H.U.Vall d'Hebrón
Spain Madrid H.C. S.Carlos
Spain Madrid H.G.U. G. Marañón
Spain Madrid H.U. F. Jiménez Díaz
Spain Madrid H.U. R. y Cajal
Spain Valencia F.I. Valenciano de Oncología
Spain Zaragoza H.U. Miguel Servet
Taiwan Taichung Municipality Taichung China Medical University Hospital
Taiwan Changhua Changhua Christian Hospital
Taiwan Tainan National Cheng Kung University Hospital
Taiwan Taipei National Taiwan University Hospital
Taiwan Taipei Veterans General Hospital- Taipei
United Kingdom Cambridgeshire Cambridge Addenbrooke's Hospital, Cambridge
United Kingdom Cambridgeshire Peterborough Peterborough And Stamford Hospitals
United Kingdom Glasgow City Glasgow Beatson West of Scotland Cancer Centre
United Kingdom London, City of London Sarah Cannon Research Institute UK (SCRI UK)
United Kingdom Midlothian Edinburgh Edinburgh Cancer Centre Western General Hospital
United Kingdom Birmingham Queen Elizabeth Hospital Brmingham
United Kingdom Cottingham Castle Hill Hospital
United Kingdom Coventry Coventry Hospital
United Kingdom London Hammersmith Hospital
United Kingdom Middlesbrough James Cook University Hospital
United Kingdom Rhyl North Wales Cancer Treatment Centre
United Kingdom Withington The Christie NHS Foundation Trust

Contact

Halozyme Study Information
1 844 855 HALO (4256)
E-mail:

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