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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02715804
Recruitment Status : Active, not recruiting
First Posted : March 22, 2016
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Halozyme Therapeutics

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

Condition or disease Intervention/treatment Phase
Stage IV Pancreatic Ductal Adenocarcinoma Other: Biological: PEGylated Recombinant Human Hyaluronidase (PEGPH20) Drug: Placebo Drug: Nab-paclitaxel Drug: Gemcitabine Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : February 25, 2016
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PEGPH20 + nab-paclitaxel + gemcitabine Other: Biological: PEGylated Recombinant Human Hyaluronidase (PEGPH20)
PEGPH20 will be administered at a dose of 3.0 micrograms per kilogram (μg/kg) as an intravenous (IV) infusion, twice weekly for Weeks 1 to 3 of Cycle 1 (each cycle consisting of 4 weeks), then once weekly for Weeks 1 to 3 of Cycle 2 and beyond. Treatment continues until disease progression, unacceptable toxicity, death, or withdrawal of consent.

Drug: Nab-paclitaxel
Nab-paclitaxel will be administered as an IV infusion at 125 milligrams per square meter (mg/m^2), once weekly for Weeks 1 to 3 of all treatment cycles.

Drug: Gemcitabine
Gemcitabine will be administered as an IV infusion at 1000 mg/m^2, once weekly for Weeks 1 to 3 of all treatment cycles.

Active Comparator: Placebo + nab-paclitaxel + gemcitabine Drug: Placebo
Matching placebo for PEGPH20

Drug: Nab-paclitaxel
Nab-paclitaxel will be administered as an IV infusion at 125 milligrams per square meter (mg/m^2), once weekly for Weeks 1 to 3 of all treatment cycles.

Drug: Gemcitabine
Gemcitabine will be administered as an IV infusion at 1000 mg/m^2, once weekly for Weeks 1 to 3 of all treatment cycles.




Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Approximately 24 months ]

Secondary Outcome Measures :
  1. Progression Free Survival [ Time Frame: Approximately 12 months ]
  2. Objective Response Rate (ORR) [ Time Frame: Approximately 12 months ]
  3. Duration of Response (DOR) [ Time Frame: Approximately 12 months ]
  4. Number of Treatment-Emergent Adverse Events (TEAEs) Considered Related to Study Drug by Investigator [ Time Frame: Approximately 12 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

Participants must satisfy all the following inclusion criteria to be enrolled in the study:

  1. Signed, written Institutional Review Board/Ethics Committee-approved Informed Consent Form(s).
  2. Stage IV pancreatic ductal adenocarcinoma (PDA) with histological or cytological confirmation of PDA.
  3. Participants must be determined to be HA-high based on archived or fresh tumor core biopsy or sample obtained after the subject has documented metastatic disease. Biopsies/samples must meet the following requirements:

    1. 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.
    2. 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.
    3. 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 (see Study Laboratory Manual).
  4. 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.
  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.
  7. Life expectancy ≥3 months.
  8. Age ≥18 years.
  9. A negative urine or serum pregnancy test within 7 days before Cycle 1, Day 1 (C1D1; first dose of study medication) if female subject is of childbearing potential.
  10. Screening clinical laboratory values as follows:

    1. Total bilirubin ≤1.5 times upper limit of normal (ULN) (subjects with Gilbert syndrome are eligible independent of bilirubin levels).
    2. 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).
    3. Serum creatinine ≤2.0 mg/dL or calculated creatinine clearance ≥40 mL/min.
    4. Serum albumin ≥2.5 g/dL.
    5. Prothrombin time or international normalized ratio (INR) within normal limits (±15%), unless subject takes warfarin, in which case prothrombin time or INR result must be within therapeutic range.
    6. Partial thromboplastin time (PTT) within normal limits (±15%).
    7. Hemoglobin ≥9 g/dL (transfusion and erythropoietic agents allowed).
    8. Absolute neutrophil count ≥1,500 cells/mm3.
    9. Platelet count ≥100,000/mm3.
  11. For women of childbearing potential (WOCBP) and for men, agreement to use a highly effective contraceptive method from the time of screening throughout the study until 1 month (WOCBP) or 6 months (men) after administration of the last dose of any study medication. Highly effective contraceptive methods consist of prior sterilization, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), oral or injectable contraceptives, barrier methods, and/or true sexual abstinence.

Exclusion criteria:

Participants are ineligible for enrollment if they meet any of the following exclusion criteria:

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

    1. Participants with superficial vein thrombosis are eligible.
    2. 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).
  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.

  3. Known central nervous system involvement or brain metastases.
  4. New York Heart Association Class III or IV cardiac disease or myocardial infarction within the past 12 months.
  5. History of cerebrovascular accident or transient ischemic attack.
  6. Clinically significant pre-existing carotid artery disease.
  7. Known infection with human immunodeficiency virus, or active infection with hepatitis B or hepatitis C within the past 12 months.
  8. Known allergy to hyaluronidase.
  9. Current use of megestrol acetate or megestrol acetate-containing drugs (use within 10 days of Day 1).
  10. Contraindication to heparin as per institutional guidelines.
  11. Women currently pregnant or breastfeeding.
  12. Intolerance to dexamethasone.
  13. History of another primary cancer within the last 3 years with the exception of non-melanoma skin cancer, early-stage prostate cancer, or curatively treated cervical carcinoma in-situ.
  14. Any other disease, active, uncontrolled bacterial, viral or fungal infection requiring systemic therapy, metabolic dysfunction, physical examination finding or clinical laboratory finding that leads to reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, or that may affect the interpretation of the results, or that may render the subject at high risk for treatment complications.
  15. Immunization with a live vaccine up to 2 weeks prior to Day 1.
  16. Hypersensitivity to the active substance or ingredients of PEGPH20, gemcitabine, and nab-paclitaxel.
  17. Inability to comply with study and follow-up procedures as judged by the Investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02715804


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Locations
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United States, Alabama
University of South Alabama
Mobile, Alabama, United States, 36604
United States, Arizona
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234-2165
United States, Arkansas
Highlands Oncology Group
Fayetteville, Arkansas, United States, 72703
United States, California
St. Jude Hospital Yorba DBA Linda St. Joseph Heritage Health
Fullerton, California, United States, 92886
Scripps Clinical Research Services
La Jolla, California, United States, 92037
Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California, United States, 90048
David Geffen School of Medicine (DGSOM) at UCLA
Los Angeles, California, United States, 90095
Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
St. Joseph Hospital
Orange, California, United States, 92868
Desert Hematology Oncology Medical Group, Inc.
Rancho Mirage, California, United States, 92270
Cancer Care Associates Medical Group, Inc.
Redondo Beach, California, United States, 90277
Pacific Hematology Oncology Associates
San Francisco, California, United States, 94115
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
Pacific Central Coast Health Centers: San Luis Obispo Oncology and Hematology Health Center
San Luis Obispo, California, United States, 93401
St Joseph Heritage Healthcare
Santa Rosa, California, United States, 95405
Innovative Clinical Research Institution
Whittier, California, United States, 90603
United States, Colorado
Kaiser Permanente Franklin Medical Offices - Denver
Denver, Colorado, United States, 80205
US Oncology - Rocky Mountain Cancer Centers - Midtown
Denver, Colorado, United States, 80218
St. Mary's Medical Center
Grand Junction, Colorado, United States, 81501
United States, Connecticut
Yale Cancer Center
New Haven, Connecticut, United States, 06510
United States, District of Columbia
MedStar Georgetown University Hospital
Washington, District of Columbia, United States, 20007
United States, Florida
Memorial Healthcare System - Memorial Cancer Institute
Hollywood, Florida, United States, 33021
21st Century Oncology
Jacksonville, Florida, United States, 32207
MD Anderson Cancer Center Orlando
Orlando, Florida, United States, 32806
United States, Indiana
Fort Wayne Medical Oncology/Hematology, INC.
Fort Wayne, Indiana, United States, 46845
United States, Kansas
The University Of Kansas Cancer Center
Kansas City, Kansas, United States, 66160
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40292
United States, Louisiana
Ochsner Health Center
Baton Rouge, Louisiana, United States, 70809
Ochsner Clinic CCOP
New Orleans, Louisiana, United States, 70119
United States, Maryland
The Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21224
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
UMass Memorial Medical Center
Worcester, Massachusetts, United States, 01605
United States, Michigan
University of Michigan Medical Center
Ann Arbor, Michigan, United States, 48109
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, Minnesota
Virginia Piper Cancer Institute
Minneapolis, Minnesota, United States, 55404
University of Minnesota Medical School
Minneapolis, Minnesota, United States, 55455
United States, Nevada
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89169
Renown Regional Medical Center
Reno, Nevada, United States, 89502
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03743
United States, New Jersey
Saint Joseph's Ambulatory Clinic
Clifton, New Jersey, United States, 07013
Jersey Shore University Medical Center
Neptune, New Jersey, United States, 07753
United States, New York
Northwell Health/Monter Cancer Center
Lake Success, New York, United States, 11042
NYU Langone Medical Center - NYU Langone Arena Oncology
New Hyde Park, New York, United States, 10016
Columbia University Medical Center
New York, New York, United States, 10019
Mount Sinai School of Medicine - The Tisch Cancer Institute
New York, New York, United States, 10029
University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, North Carolina
Rex Cancer Center
Raleigh, North Carolina, United States, 27607
United States, Ohio
Gabrail Cancer Center Research
Canton, Ohio, United States, 44718
United States, Oklahoma
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Univ of Pittsburgh Cancer institute
Pittsburgh, Pennsylvania, United States, 15232
United States, Texas
Baylor College of Medicine - Baylor Clinic
Houston, Texas, United States, 77030
Scott and White
Temple, Texas, United States, 76508
United States, Utah
University of Utah - Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84103
United States, Virginia
Inova Dwight and Martha Schar Cancer Institute
Fairfax, Virginia, United States, 22031
Fort Belvoir Community Hospital
Fort Belvoir, Virginia, United States, 22060
Virginia Cancer Institute
Mechanicsville, Virginia, United States, 23116
United States, Washington
Swedish Cancer Institute/ Swedish Health Services
Seattle, Washington, United States, 98104
University of Washington (UW) - Seattle Cancer Care Alliance
Seattle, Washington, United States, 98195
Northwest Medical Specialties PLLC
Tacoma, Washington, United States, 98405
United States, Wisconsin
University of Wisconsin Health - UW Carbone Cancer Center
Madison, Wisconsin, United States, 53792
Columbia St. Marys
Milwaukee, Wisconsin, United States, 53211
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Australia, New South Wales
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
Australia, South Australia
Flinders Medical Centre
Bedford, South Australia, Australia
Australia, Victoria
Bendigo Health Care Group
Bendigo, Victoria, Australia
Monash Health
Bentleigh East, Victoria, Australia
Peninsula & South Eastern Haematology and Oncology Group
Frankston, Victoria, Australia
Belgium
Imelda Ziekenhuis
Bonheiden, Antwerpen, Belgium
UZA
Edegem, Antwerpen, Belgium
Cliniques Universitaires Saint-Luc
Brussels, Brussels Capital Region, Belgium, 1200
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
Brazil
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
Canada, Ontario
Royal Victoria Regional Health Centre
Barrie, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Croatia
Klinicki bolnicki centar Zagreb
Zagreb, Grad Zagreb, Croatia
Klinicki bolnički centar Sestre milosrdnice
Zagreb, Croatia
Czechia
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
Denmark
Odense Universitetshospital
Odense, South Denmark, Denmark
Estonia
East Tallinn Central Hospital Oncology Center
Tallinn, Harjumaa, Estonia
North Estonian Medical Centre Foundation Clinic of Oncology
Tallinn, Harjumaa, Estonia
France
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
Germany
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
Hungary
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
Israel
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
Italy
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
Korea, Republic of
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
Latvia
Daugavpils Regional Hospital
Daugavpils, Latvia
P.Stradins Clinical University
Riga, Latvia
SIA "Rigas Austrumu Kliniska Universitates Slimnica"
Riga, Latvia
Lithuania
National Cancer Institute
Vilnius, Vilniaus Apskritis, Lithuania
Vilniaus Universiteto ligonines Santariskiu Klinikos
Vilnius, Vilniaus Apskritis, Lithuania
Netherlands
Maastricht University Medical Centre
Maastricht, Limburg, Netherlands
Academisch Medisch Centrum Universiteit van Amsterdam
Amsterdam, Netherlands
Spaarne Gasthuis
Hoofddorp, Netherlands
Radboud Universiteit Nijmegen
Nijmegen, Netherlands
Poland
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
Spain
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
Taiwan
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
United Kingdom
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
Sponsors and Collaborators
Halozyme Therapeutics

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Responsible Party: Halozyme Therapeutics
ClinicalTrials.gov Identifier: NCT02715804     History of Changes
Other Study ID Numbers: HALO-109-301
2015-004068-13 ( EudraCT Number )
First Posted: March 22, 2016    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Halozyme Therapeutics:
Pancreatic ductal adenocarcinoma (PDA)
Pancreatic ductal carcinoma
PEGylated Recombinant Human Hyaluronidase (PEGPH20)
Nab-paclitaxel
Gemcitabine
Metastatic
Stage IV

Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Paclitaxel
Albumin-Bound Paclitaxel
Gemcitabine
Hyaluronic Acid
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Viscosupplements
Protective Agents