Study Stopped
Sponsor decision
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
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
2 other identifiers
interventional
492
21 countries
202
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2016
Typical duration for phase_3
202 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 14, 2016
CompletedFirst Submitted
Initial submission to the registry
March 17, 2016
CompletedFirst Posted
Study publicly available on registry
March 22, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 4, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 4, 2019
CompletedResults Posted
Study results publicly available
July 14, 2020
CompletedJuly 14, 2020
June 1, 2020
3.6 years
March 17, 2016
June 11, 2020
June 30, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival
Overall survival was defined as the time from randomization until death from any cause. Overall survival was analyzed using Kaplan-Meier methods.
From randomization until death from any cause (maximum exposure: 150.1 weeks for PAG, and 83.9 weeks for AG)
Secondary Outcomes (7)
Progression-Free Survival (PFS)
From the date of randomization until disease progression or death from any cause (maximum exposure: 150.1 weeks for PAG, and 83.9 weeks for AG)
Objective Response Rate (ORR): Percentage of Participants With Objective Response
From the date of randomization until CR or PR (maximum exposure: 150.1 weeks for PAG, and 83.9 weeks for AG)
Duration of Response (DOR)
From date of first objective response (CR or PR) until date of first disease progression (maximum exposure: 150.1 weeks for PAG, and 83.9 weeks for AG)
Number of Participants With Treatment-Emergent Adverse Events (AEs)
From administration of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 150.1 weeks for PAG, and 83.9 weeks for AG)
Number of Participants With Worst Post-Baseline Hematology and Chemistry (Clinical Laboratory Parameters) Severity Grade During the Study
From administration of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 150.1 weeks for PAG, and 83.9 weeks for AG)
- +2 more secondary outcomes
Study Arms (2)
PAG: PEGPH20 + nab-Paclitaxel + Gemcitabine
EXPERIMENTALParticipants will receive 3.0 micrograms/kilogram (μg/kg) PEGPH20 as an intravenous (IV) infusion, twice weekly for Weeks 1 to 3 of Cycle 1 (each cycle consisting of 4 weeks \[Week 4 of every cycle will be a rest week with no treatment\]), then once weekly for Weeks 1 to 3 of Cycle 2 and beyond in combination with 125 milligrams/square meter (mg/m\^2) nab-paclitaxel as an IV infusion and 1000 mg/m\^2 gemcitabine as an IV infusion, once weekly for Weeks 1 to 3 of all treatment cycles. Treatment will continue until disease progression, unacceptable toxicity, death, or withdrawal of consent.
AG: Placebo + nab-Paclitaxel + Gemcitabine
PLACEBO COMPARATORParticipants will receive placebo matching to PEGPH20 as an IV infusion, twice weekly for Weeks 1 to 3 of Cycle 1 (each cycle consisting of 4 weeks \[Week 4 of every cycle will be a rest week with no treatment\]), then once weekly for Weeks 1 to 3 of Cycle 2 and beyond in combination with 125 mg/m\^2 nab-paclitaxel as an IV infusion and 1000 mg/m\^2 gemcitabine as an IV infusion, once weekly for Weeks 1 to 3 of all treatment cycles. Treatment will continue until disease progression, unacceptable toxicity, death, or withdrawal of consent.
Interventions
PEGPH20 will be administered as per the dose and schedule specified in the respective arms.
Nab-paclitaxel will be administered as per the dose and schedule specified in the respective arms.
Gemcitabine will be administered as per the dose and schedule specified in the respective arms.
Eligibility Criteria
You may qualify if:
- Signed, written Institutional Review Board/Ethics Committee-approved Informed Consent Form (ICF).
- Stage IV PDA with histological or cytological confirmation of PDA.
- Participants must be determined to be HA-high based on archived or fresh tumor core biopsy or sample obtained after the participant has documented metastatic disease. Biopsies/samples must meet the following requirements:
- Pancreas tumor biopsies/samples obtained on or after the date that metastatic disease is documented or tumor biopsies/samples from a metastatic lesion are acceptable.
- Tumor biopsies or samples must meet the requirements provided in the Study Laboratory Manual with regard to tumor tissue architecture. Note: cytology samples from fine needle aspirates without maintained tissue architecture or brushing biopsies are not acceptable.
- Tumor tissue (formalin-fixed paraffin-embedded \[FFPE\] block preferred) must include enough tumor to make a minimum of 5-10 unstained, consecutive FFPE slides (10 slides are preferred) of 1 archival block that meet specific tissue sample requirements.
- Radiographic confirmation of Stage IV PDA with at least 1 tumor metastasis measurable on computed tomography (CT) scan or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria, excluding the primary pancreatic lesion.
- 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 less than or equal to (≤) Grade 1.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Life expectancy greater than or equal to (≥) 3 months.
- Age ≥18 years.
- A negative urine or serum pregnancy test within 7 days before Cycle 1, Day 1 (C1D1; first dose of study medication) if female participant is of childbearing potential.
- Screening clinical laboratory values as follows:
- Total bilirubin ≤1.5 times upper limit of normal (ULN) (participants with Gilbert syndrome are eligible independent of bilirubin levels).
- Aspartate aminotransferase (serum glutamic oxaloacetic transaminase) and alanine aminotransferase (serum glutamic pyruvate transaminase) ≤2.5 times ULN, (if liver metastases are present, then ≤5 times ULN is allowed).
- +8 more criteria
You may not qualify if:
- Clinical evidence of deep vein thrombosis (DVT), pulmonary embolism (PE) or other known thromboembolic (TE) event present during the screening period.
- Participants with superficial vein thrombosis are eligible.
- Participants with visceral/splanchnic vein thrombosis are still eligible if, in the opinion of the Investigator, the visceral/splanchnic vein thrombosis is primarily associated with the anatomic location of the underlying disease of metastatic pancreatic cancer (there must be primary or metastatic disease in reasonable proximity to the thrombosis, and the Investigator determines that the thrombosis is due to a local tumor event and not a coagulation issue).
- 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.
- Known central nervous system involvement or brain metastases.
- New York Heart Association Class III or IV cardiac disease or myocardial infarction within the past 12 months.
- History of cerebrovascular accident or transient ischemic attack.
- Clinically significant pre-existing carotid artery disease.
- Known infection with human immunodeficiency virus, or active infection with hepatitis B or hepatitis C within the past 12 months.
- Known allergy to hyaluronidase.
- Current use of megestrol acetate or megestrol acetate-containing drugs (use within 10 days of Day 1).
- Contraindication to heparin as per institutional guidelines.
- Women currently pregnant or breastfeeding.
- Intolerance to dexamethasone.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (217)
University of South Alabama
Mobile, Alabama, 36604, United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234-2165, United States
Highlands Oncology Group
Fayetteville, Arkansas, 72703, United States
St. Jude Hospital Yorba DBA Linda St. Joseph Heritage Health
Fullerton, California, 92886, United States
Scripps Clinical Research Services
La Jolla, California, 92037, United States
Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California, 90048, United States
David Geffen School of Medicine (DGSOM) at UCLA
Los Angeles, California, 90095, United States
Chao Family Comprehensive Cancer Center
Orange, California, 92868, United States
St. Joseph Hospital
Orange, California, 92868, United States
Desert Hematology Oncology Medical Group, Inc.
Rancho Mirage, California, 92270, United States
Cancer Care Associates Medical Group, Inc.
Redondo Beach, California, 90277, United States
Pacific Hematology Oncology Associates
San Francisco, California, 94115, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94115, United States
Pacific Central Coast Health Centers: San Luis Obispo Oncology and Hematology Health Center
San Luis Obispo, California, 93401, United States
St Joseph Heritage Healthcare
Santa Rosa, California, 95405, United States
Innovative Clinical Research Institution
Whittier, California, 90603, United States
Kaiser Permanente Franklin Medical Offices - Denver
Denver, Colorado, 80205, United States
US Oncology - Rocky Mountain Cancer Centers - Midtown
Denver, Colorado, 80218, United States
St. Mary's Medical Center
Grand Junction, Colorado, 81501, United States
Yale Cancer Center
New Haven, Connecticut, 06510, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
Memorial Healthcare System - Memorial Cancer Institute
Hollywood, Florida, 33021, United States
21st Century Oncology
Jacksonville, Florida, 32207, United States
MD Anderson Cancer Center Orlando
Orlando, Florida, 32806, United States
Fort Wayne Medical Oncology/Hematology, INC.
Fort Wayne, Indiana, 46845, United States
The University Of Kansas Cancer Center
Kansas City, Kansas, 66160, United States
University of Louisville
Louisville, Kentucky, 40292, United States
Ochsner Health Center
Baton Rouge, Louisiana, 70809, United States
Ochsner Clinic CCOP
New Orleans, Louisiana, 70119, United States
The Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21224, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
UMass Memorial Medical Center
Worcester, Massachusetts, 01605, United States
University of Michigan Medical Center
Ann Arbor, Michigan, 48109, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Virginia Piper Cancer Institute
Minneapolis, Minnesota, 55404, United States
University of Minnesota Medical School
Minneapolis, Minnesota, 55455, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169, United States
Renown Regional Medical Center
Reno, Nevada, 89502, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03743, United States
Saint Joseph's Ambulatory Clinic
Clifton, New Jersey, 07013, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, 07753, United States
Northwell Health/Monter Cancer Center
Lake Success, New York, 11042, United States
NYU Langone Medical Center - NYU Langone Arena Oncology
New Hyde Park, New York, 10016, United States
Columbia University Medical Center
New York, New York, 10019, United States
Mount Sinai School of Medicine - The Tisch Cancer Institute
New York, New York, 10029, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
Rex Cancer Center
Raleigh, North Carolina, 27607, United States
Gabrail Cancer Center Research
Canton, Ohio, 44718, United States
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
Univ of Pittsburgh Cancer institute
Pittsburgh, Pennsylvania, 15232, United States
Baylor College of Medicine - Baylor Clinic
Houston, Texas, 77030, United States
Scott and White
Temple, Texas, 76508, United States
University of Utah - Huntsman Cancer Institute
Salt Lake City, Utah, 84103, United States
Inova Dwight and Martha Schar Cancer Institute
Fairfax, Virginia, 22031, United States
Fort Belvoir Community Hospital
Fort Belvoir, Virginia, 22060, United States
Virginia Cancer Institute
Mechanicsville, Virginia, 23116, United States
Swedish Cancer Institute/ Swedish Health Services
Seattle, Washington, 98104, United States
University of Washington (UW) - Seattle Cancer Care Alliance
Seattle, Washington, 98195, United States
Northwest Medical Specialties PLLC
Tacoma, Washington, 98405, United States
University of Wisconsin Health - UW Carbone Cancer Center
Madison, Wisconsin, 53792, United States
Columbia St. Marys
Milwaukee, Wisconsin, 53211, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, 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, 1200, Belgium
Hôpital Erasme
Brussels, Brussels Capital, Belgium
AZ Maria Middelares - Campus Maria Middelares
Ghent, Oost-Vlaanderen, Belgium
UZ Leuven - Campus Gasthuisberg
Leuven, Vlaams Brabant, Belgium
Centre Hospitalier Universitaire (CHU) de Liege - Domaine Un
Liège, 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 André, São Paulo, Brazil
Faculdade de Medicina da Universidade de Sao Paulo
São 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, City of Zagreb, Croatia
Klinicki bolnički centar Sestre milosrdnice
Zagreb, Croatia
Masarykuv onkologicky ustav
Brno, Brno-město, Czechia
FN Hradec Kralove
Hradec Králové, Královéhradecký kraj, Czechia
Fakultni nemocnice Olomouc
Olomouc, Olomoucký kraj, Czechia
Fakultni nemocnice v Motole
Prague, Czechia
Nemocnice Na Bulovce (Hospital Na Bulovce)
Prague, Czechia
Odense Universitetshospital
Odense, Region Syddanmark, Denmark
East Tallinn Central Hospital Oncology Center
Tallinn, Harju, Estonia
North Estonian Medical Centre Foundation Clinic of Oncology
Tallinn, Harju, Estonia
Centre Eugene Marquis
Rennes, Brittany Region, France
Hospitalier Jean Minjoz
Besançon, 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, Rhône, France
Institut De Cancerologie Gustave Roussy
Villejuif, Val-de-Marne, France
Institut de Cancérologie de l'Ouest - Site Paul Papin
Angers, France
Hôpital Haut-Leveque
Bordeaux, France
Henri Mondor - Albert Chevenier
Créteil, France
Centre Lyon Berard
Lyon, France
Hopital Privé Jean Mermoz
Lyon, France
Institut Mutualiste Montsouris
Paris, France
Pitié Salpetriere Hospital
Paris, France
Hôpital Beaujon
Clichy, Île-de-France Region, France
Universitätsklinikum Ulm
Ulm, Baden-Wurttemberg, Germany
Klinikum der Universität München - Campus Grosshadern
München, Bavaria, Germany
Universitätsklinikum Bonn
Bonn, North Rhine-Westphalia, Germany
Uniklinik Köln-Klinik für Gastroenterologie und Hepatologie am Abdominalzentrum
Cologne, North Rhine-Westphalia, Germany
Universitätsklinik Carl-Gustav-Carus Dresden
Dresden, Saxony, Germany
Universitätsklinikum Leipzig AöR
Leipzig, Saxony, 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 megye, Hungary
Petz Aladár Megyei Oktató Kórház
Győr, Győr-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, Central District, Israel
Meir Medical Center
Kfar Saba, Central District, Israel
Rabin Medical Center - Beilinson Hospital
Petah Tikva, Central District, Israel
Hadassah Medical Organisation
Jerusalem, Jerusalem, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Tel Aviv, Israel
Ha'Emek Medical Center
Afula, Israel
Soroka Medical Center [Oncology]
Beersheba, 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 Litwinsky, 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
Ieo, Irccs
Milan, Italy
IRCCS Ospedale S.Raffaele
Milan, Italy
Istituto Oncologico Veneto IOV-IRCCS
Padua, Italy
Regina Elena, Istituto Nazionale dei Tumori, IFO, IRCCS
Roma, Italy
Borgo Roma, Policlinico G.Rossi, AOU Integrata Verona
Verona, Italy
Daugavpils Regional Hospital
Daugavpils, Latvia
P.Stradins Clinical University
Riga, Latvia
SIA "Rigas Austrumu Kliniska Universitates Slimnica"
Riga, Latvia
National Cancer Institute
Vilnius, Vilnius County, Lithuania
Vilniaus Universiteto ligonines Santariskiu Klinikos
Vilnius, Vilnius County, 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
Brzozów, Podkarpackie Voivodeship, Poland
Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
Lublin, Poland
Centrum Onkologii Instytut im. M. Sklodowskiej-Curie
Warsaw, Poland
Dong-A University Hospital
Busan, Busan Gwang'yeogsi, South Korea
Keimyung University Dongsan Medical Center
Daegu, Daegu Gwang'yeogsi, South Korea
Seoul National University Bundang Hospital
Seongnam, Gyeonggido, South Korea
Asan Medical Center
Seoul, Seoul Teugbyeolsi, South Korea
Korea University Anam Hospital
Seoul, Seoul Teugbyeolsi, South Korea
Samsung Medical Center
Seoul, Seoul Teugbyeolsi, South Korea
Severance Hospital, Yonsei University Health System
Seoul, Seoul Teugbyeolsi, South Korea
The Catholic University of Korea, Seoul St.Mary's Hospital
Seoul, Seoul Teugbyeolsi, South Korea
Gachon University Gil Medical Center
Incheon, South Korea
Korea University Guro Hospital
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
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, Navarre, 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
The Clatterbridge Cancer Centre NHS Foundation Trust
Metropolitan Borough of Wirral, United Kingdom
North Wales Cancer Treatment Centre
Rhyl, United Kingdom
The Christie NHS Foundation Trust
Withington, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Due to the negative study outcome, development of PEGPH20 was terminated.
Results Point of Contact
- Title
- VP, Medical, Regulatory and Drug Safety
- Organization
- Halozyme Therapeutics
Study Officials
- STUDY DIRECTOR
VP, Medical, Regulatory and Drug Safety
Halozyme Therapeutics
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 17, 2016
First Posted
March 22, 2016
Study Start
March 14, 2016
Primary Completion
November 4, 2019
Study Completion
November 4, 2019
Last Updated
July 14, 2020
Results First Posted
July 14, 2020
Record last verified: 2020-06