Clinical trial NCT02715804: 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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Pancreatic Ductal Carcinoma
Keywords: Pancreatic ductal adenocarcinoma (PDA)
Pancreatic ductal carcinoma
PEGylated Recombinant Human Hyaluronidase (PEGPH20)
Nab-paclitaxel
Gemcitabine
Metastatic
Stage IV
Lead sponsor: Halozyme Therapeutics
Sponsor class: INDUSTRY
First posted: 2016-03-22
Enrollment: 492
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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 (ICF).
2. Stage IV 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 participant 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.
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 less than or equal to (≤) Grade 1.
6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
7. Life expectancy greater than or equal to (≥) 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 participant is of childbearing potential.
10. Screening clinical laboratory values as follows:

    1. Total bilirubin ≤1.5 times upper limit of normal (ULN) (participants 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 milligrams/deciliter (mg/dL) or calculated creatinine clearance ≥40 milliliters/minute (mL/min).
    4. Serum albumin ≥2.5 grams/deciliter (g/dL).
    5. Prothrombin time or international normalized ratio (INR) within normal limits (±15%), unless participant 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/cubic millimeter (cells/mm\^3).
    9. Platelet count ≥100,000/mm\^3.
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 thromboembolic (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 participant 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.

Primary outcomes:
measure: Overall Survival
timeFrame: From randomization until death from any cause (maximum exposure: 150.1 weeks for PAG, and 83.9 weeks for AG)
Secondary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: 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)
measure: Objective Response Rate (ORR): Percentage of Participants With Objective Response
timeFrame: From the date of randomization until CR or PR (maximum exposure: 150.1 weeks for PAG, and 83.9 weeks for AG)
measure: Duration of Response (DOR)
timeFrame: 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)
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs)
timeFrame: 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)
measure: Number of Participants With Worst Post-Baseline Hematology and Chemistry (Clinical Laboratory Parameters) Severity Grade During the Study
timeFrame: 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)
measure: Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG)
timeFrame: 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)
measure: Number of Participants With Clinically Significant Abnormalities in Vital Signs
timeFrame: 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)
Other outcomes:
Locations:
city: Mobile
country: United States
facility: University of South Alabama
state: Alabama
city: Gilbert
country: United States
facility: Banner MD Anderson Cancer Center
state: Arizona
city: Fayetteville
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: Fullerton
country: United States
facility: St. Jude Hospital Yorba DBA Linda St. Joseph Heritage Health
state: California
city: La Jolla
country: United States
facility: Scripps Clinical Research Services
state: California
city: Los Angeles
country: United States
facility: Samuel Oschin Comprehensive Cancer Institute
state: California
city: Los Angeles
country: United States
facility: David Geffen School of Medicine (DGSOM) at UCLA
state: California
city: Orange
country: United States
facility: Chao Family Comprehensive Cancer Center
state: California
city: Orange
country: United States
facility: St. Joseph Hospital
state: California
city: Rancho Mirage
country: United States
facility: Desert Hematology Oncology Medical Group, Inc.
state: California
city: Redondo Beach
country: United States
facility: Cancer Care Associates Medical Group, Inc.
state: California
city: San Francisco
country: United States
facility: Pacific Hematology Oncology Associates
state: California
city: San Francisco
country: United States
facility: UCSF Helen Diller Family Comprehensive Cancer Center
state: California
city: San Luis Obispo
country: United States
facility: Pacific Central Coast Health Centers: San Luis Obispo Oncology and Hematology Health Center
state: California
city: Santa Rosa
country: United States
facility: St Joseph Heritage Healthcare
state: California
city: Whittier
country: United States
facility: Innovative Clinical Research Institution
state: California
city: Denver
country: United States
facility: Kaiser Permanente Franklin Medical Offices - Denver
state: Colorado
city: Denver
country: United States
facility: US Oncology - Rocky Mountain Cancer Centers - Midtown
state: Colorado
city: Grand Junction
country: United States
facility: St. Mary's Medical Center
state: Colorado
city: New Haven
country: United States
facility: Yale Cancer Center
state: Connecticut
city: Washington
country: United States
facility: MedStar Georgetown University Hospital
state: District of Columbia
city: Hollywood
country: United States
facility: Memorial Healthcare System - Memorial Cancer Institute
state: Florida
city: Jacksonville
country: United States
facility: 21st Century Oncology
state: Florida
city: Orlando
country: United States
facility: MD Anderson Cancer Center Orlando
state: Florida
city: Fort Wayne
country: United States
facility: Fort Wayne Medical Oncology/Hematology, INC.
state: Indiana
city: Kansas City
country: United States
facility: The University Of Kansas Cancer Center
state: Kansas
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Baton Rouge
country: United States
facility: Ochsner Health Center
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Clinic CCOP
state: Louisiana
city: Baltimore
country: United States
facility: The Sidney Kimmel Comprehensive Cancer Center
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Worcester
country: United States
facility: UMass Memorial Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Medical Center
state: Michigan
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Minneapolis
country: United States
facility: Virginia Piper Cancer Institute
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota Medical School
state: Minnesota
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Reno
country: United States
facility: Renown Regional Medical Center
state: Nevada
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Clifton
country: United States
facility: Saint Joseph's Ambulatory Clinic
state: New Jersey
city: Neptune
country: United States
facility: Jersey Shore University Medical Center
state: New Jersey
city: Lake Success
country: United States
facility: Northwell Health/Monter Cancer Center
state: New York
city: New Hyde Park
country: United States
facility: NYU Langone Medical Center - NYU Langone Arena Oncology
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: New York
country: United States
facility: Mount Sinai School of Medicine - The Tisch Cancer Institute
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Raleigh
country: United States
facility: Rex Cancer Center
state: North Carolina
city: Canton
country: United States
facility: Gabrail Cancer Center Research
state: Ohio
city: Oklahoma City
country: United States
facility: The University of Oklahoma Health Sciences Center
state: Oklahoma
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Univ of Pittsburgh Cancer institute
state: Pennsylvania
city: Houston
country: United States
facility: Baylor College of Medicine - Baylor Clinic
state: Texas
city: Temple
country: United States
facility: Scott and White
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah - Huntsman Cancer Institute
state: Utah
city: Fairfax
country: United States
facility: Inova Dwight and Martha Schar Cancer Institute
state: Virginia
city: Fort Belvoir
country: United States
facility: Fort Belvoir Community Hospital
state: Virginia
city: Mechanicsville
country: United States
facility: Virginia Cancer Institute
state: Virginia
city: Seattle
country: United States
facility: Swedish Cancer Institute/ Swedish Health Services
state: Washington
city: Seattle
country: United States
facility: University of Washington (UW) - Seattle Cancer Care Alliance
state: Washington
city: Tacoma
country: United States
facility: Northwest Medical Specialties PLLC
state: Washington
city: Madison
country: United States
facility: University of Wisconsin Health - UW Carbone Cancer Center
state: Wisconsin
city: Milwaukee
country: United States
facility: Columbia St. Marys
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Bankstown
country: Australia
facility: Bankstown-Lidcombe Hospital
state: New South Wales
city: Camperdown
country: Australia
facility: Chris O'Brien Lifehouse
state: New South Wales
city: Darlinghurst
country: Australia
facility: St Vincent's Hospital
state: New South Wales
city: St Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Bedford
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Bendigo
country: Australia
facility: Bendigo Health Care Group
state: Victoria
city: Bentleigh East
country: Australia
facility: Monash Health
state: Victoria
city: Frankston
country: Australia
facility: Peninsula & South Eastern Haematology and Oncology Group
state: Victoria
city: Bonheiden
country: Belgium
facility: Imelda Ziekenhuis
state: Antwerpen
city: Edegem
country: Belgium
facility: UZA
state: Antwerpen
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
state: Brussels Capital Region
city: Bruxelles
country: Belgium
facility: Hôpital Erasme
state: Brussels Capital Region
city: Gent
country: Belgium
facility: AZ Maria Middelares - Campus Maria Middelares
state: Oost-Vlaanderen
city: Leuven
country: Belgium
facility: UZ Leuven - Campus Gasthuisberg
state: Vlaams Brabant
city: Liege
country: Belgium
facility: Centre Hospitalier Universitaire (CHU) de Liege - Domaine Un
city: Belo Horizonte
country: Brazil
facility: CENANTRON - Centro Avançado de Tratamento Oncologico
state: Minas Gerais
city: Passo Fundo
country: Brazil
facility: Hospital da Cidade de Passo Fundo
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre - UFRGS
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital São Lucas da PUCRS
state: Rio Grande Do Sul
city: Campinas
country: Brazil
facility: Occ -Oncologia Clínica De Campinas
state: São Paulo
city: Jaú
country: Brazil
facility: Fundação Amaral Cravalho / Hospital Amaral Carvalho
state: São Paulo
city: Santo Andre
country: Brazil
facility: Fm Abc/ Cepho
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Faculdade de Medicina da Universidade de Sao Paulo
state: São Paulo
city: Barretos
country: Brazil
facility: Fundacao Pio XII Hospital De Câncer de Barretos
city: Rio de Janeiro
country: Brazil
facility: Instituto COI
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional de Câncer - INCA
city: Barrie
country: Canada
facility: Royal Victoria Regional Health Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Zagreb
country: Croatia
facility: Klinicki bolnicki centar Zagreb
state: Grad Zagreb
city: Zagreb
country: Croatia
facility: Klinicki bolnički centar Sestre milosrdnice
city: Brno
country: Czechia
facility: Masarykuv onkologicky ustav
state: Brno-město
city: Hradec Kralove
country: Czechia
facility: FN Hradec Kralove
state: Královéhradecký Kraj
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc
state: Olomoucký Kraj
city: Prague
country: Czechia
facility: Nemocnice Na Bulovce (Hospital Na Bulovce)
city: Praha 5
country: Czechia
facility: Fakultni nemocnice v Motole
city: Odense
country: Denmark
facility: Odense Universitetshospital
state: South Denmark
city: Tallinn
country: Estonia
facility: East Tallinn Central Hospital Oncology Center
state: Harjumaa
city: Tallinn
country: Estonia
facility: North Estonian Medical Centre Foundation Clinic of Oncology
state: Harjumaa
city: Rennes Cedex
country: France
facility: Centre Eugene Marquis
state: Bretagne
city: Besançon cedex
country: France
facility: Hospitalier Jean Minjoz
state: Franche-Comté
city: Montpellier
country: France
facility: ICM Val d'Aurelle Saint Eloi - Departement Oncologie
state: Hérault
city: Saint Herblain
country: France
facility: ICO - Site Ren Gauducheau
state: Loire-Atlantique
city: Clermont-Ferrand
country: France
facility: CHU Estaing
state: Puy-de-Dôme
city: Lyon Cedex 03
country: France
facility: Hopital Edouard Herriot
state: Rhône
city: Villejuif
country: France
facility: Institut De Cancerologie Gustave Roussy
state: Val-de-Marne
city: Angers Cedex 02
country: France
facility: Institut de Cancérologie de l'Ouest - Site Paul Papin
city: Bordeaux
country: France
facility: Hôpital Haut-Leveque
city: Créteil
country: France
facility: Henri Mondor - Albert Chevenier
city: Lyon Cedex
country: France
facility: Centre Lyon Berard
city: Lyon
country: France
facility: Hopital Privé Jean Mermoz
city: Paris
country: France
facility: Institut Mutualiste Montsouris
city: Paris
country: France
facility: Pitié Salpetriere Hospital
city: Clichy Cedex
country: France
facility: Hôpital Beaujon
state: Île-de-France
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
state: Baden-Württemberg
city: München
country: Germany
facility: Klinikum der Universität München - Campus Grosshadern
state: Bayern
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
state: Nordrhein-Westfalen
city: Koeln
country: Germany
facility: Uniklinik Köln-Klinik für Gastroenterologie und Hepatologie am Abdominalzentrum
state: Nordrhein-Westfalen
city: Dresden
country: Germany
facility: Universitätsklinik Carl-Gustav-Carus Dresden
state: Sachsen
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig AöR
state: Sachsen
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Essen
country: Germany
facility: Kliniken Essen-Mitte Evang. Huyssens-Stiftung
city: Halle
country: Germany
facility: Universitätsklinikum Halle-Universitätsklinik und Poliklinik
city: Hamburg
country: Germany
facility: Facharztzentrum Eppendorf
city: Heidelberg
country: Germany
facility: Universitätskllinikum Heidelberg
city: Pécs
country: Hungary
facility: Pécsi Tudományegyetem Klinikai Központ
state: Baranya
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpo
state: Csongrád
city: Győr
country: Hungary
facility: Petz Aladár Megyei Oktató Kórház
state: Gyor-Moson-Sopron
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Központ
state: Hajdú-Bihar
city: Budapest
country: Hungary
facility: Egyesített Szent István és Szent László Kórház-Rendelőintéze
city: Budapest
country: Hungary
facility: Magyar Honvédség Egészségügyi Központ
city: Budapest
country: Hungary
facility: Országos Onkológiai Intézet
city: Budapest
country: Hungary
facility: Semmelweis Egyetem - Isz. Bel, Onkológiai Részleg
city: Budapest
country: Hungary
facility: Semmelweis Egyetem - Onkohaematológiai Osztály
city: Budapest
country: Hungary
facility: Szent Margit Kórház
city: Kaposvár
country: Hungary
facility: Somogy Megyei Kaposi Mór Oktató Kórház
city: Be'er Ya'aqov
country: Israel
facility: Assaf Harofeh Medical Center
state: HaMerkaz
city: Kfar-Saba
country: Israel
facility: Meir Medical Center
state: HaMerkaz
city: Petah Tikva
country: Israel
facility: Rabin Medical Center - Beilinson Hospital
state: HaMerkaz
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
state: Tel-Aviv
city: Jerusalem
country: Israel
facility: Hadassah Medical Organisation
state: Yerushalayim
city: Afula
country: Israel
facility: Ha'Emek Medical Center
city: Beer Sheva
country: Israel
facility: Soroka Medical Center [Oncology]
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Tel Hashomer
country: Israel
facility: The Chaim Sheba Medical Center [Oncology]
city: San Giovanni Rotondo
country: Italy
facility: U.O. di Oncologia
state: Foggia
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas Rozzano, IRCCS
state: Milano
city: Cremona
country: Italy
facility: PO di Cremona, ASST di Cremona
city: Genova
country: Italy
facility: AO S. Martino, IRCCS, IST-Istituto Nazionale Ricerca Sul Cancro
city: Milano
country: Italy
facility: IRCCS Ospedale S.Raffaele
city: Milan
country: Italy
facility: Ieo, Irccs
city: Padova
country: Italy
facility: Istituto Oncologico Veneto IOV-IRCCS
city: Roma
country: Italy
facility: Regina Elena, Istituto Nazionale dei Tumori, IFO, IRCCS
city: Verona
country: Italy
facility: Borgo Roma, Policlinico G.Rossi, AOU Integrata Verona
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
state: Busan Gwang'yeogsi
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
state: Daegu Gwang'yeogsi
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggido
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St.Mary's Hospital
state: Seoul Teugbyeolsi
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Daugavpils
country: Latvia
facility: Daugavpils Regional Hospital
city: Riga
country: Latvia
facility: P.Stradins Clinical University
city: Riga
country: Latvia
facility: SIA "Rigas Austrumu Kliniska Universitates Slimnica"
city: Vilnius
country: Lithuania
facility: National Cancer Institute
state: Vilniaus Apskritis
city: Vilnius
country: Lithuania
facility: Vilniaus Universiteto ligonines Santariskiu Klinikos
state: Vilniaus Apskritis
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre
state: Limburg
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum Universiteit van Amsterdam
city: Hoofddorp
country: Netherlands
facility: Spaarne Gasthuis
city: Nijmegen
country: Netherlands
facility: Radboud Universiteit Nijmegen
city: Brzozow
country: Poland
facility: Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onko
state: Podkarpackie
city: Lublin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
city: Warszawa
country: Poland
facility: Centrum Onkologii Instytut im. M. Sklodowskiej-Curie
city: Badalona
country: Spain
facility: Institut Català d'Oncologia-Hospital Germans Trias i Pujol
state: Barcelona
city: L'Hospitalet De Llobregat
country: Spain
facility: Institut Catalá d´Oncología (I.C.O.)
state: Barcelona
city: Fuenlabrada
country: Spain
facility: H.U. de Fuenlabrada
state: Madrid
city: Pamplona
country: Spain
facility: Clínica Universidad de Navarra
state: Navarra
city: Barcelona
country: Spain
facility: H.del Mar
city: Barcelona
country: Spain
facility: H.Sta.Creu i St.Pau
city: Barcelona
country: Spain
facility: H.U.Vall d'Hebrón
city: Madrid
country: Spain
facility: H.C. S.Carlos
city: Madrid
country: Spain
facility: H.G.U. G. Marañón
city: Madrid
country: Spain
facility: H.U. F. Jiménez Díaz
city: Madrid
country: Spain
facility: H.U. R. y Cajal
city: Madrid
country: Spain
facility: Hospital Madrid Norte Sanchinarro
city: Valencia
country: Spain
facility: F.I. Valenciano de Oncología
city: Valencia
country: Spain
facility: Hospital Universitari i Politècnic La Fe
city: Zaragoza
country: Spain
facility: H.U. Miguel Servet
city: Taichung
country: Taiwan
facility: China Medical University Hospital
state: Taichung Municipality
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Veterans General Hospital- Taipei
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital, Cambridge
state: Cambridgeshire
city: Peterborough
country: United Kingdom
facility: Peterborough And Stamford Hospitals
state: Cambridgeshire
city: Glasgow
country: United Kingdom
facility: Beatson West of Scotland Cancer Centre
state: Glasgow City
city: London
country: United Kingdom
facility: Sarah Cannon Research Institute UK (SCRI UK)
state: London, City Of
city: Edinburgh
country: United Kingdom
facility: Edinburgh Cancer Centre Western General Hospital
state: Midlothian
city: Birkenhead
country: United Kingdom
facility: The Clatterbridge Cancer Centre NHS Foundation Trust
state: Wirral
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital Birmingham
city: Cottingham
country: United Kingdom
facility: Castle Hill Hospital
city: Coventry
country: United Kingdom
facility: Coventry Hospital
city: London
country: United Kingdom
facility: Hammersmith Hospital
city: London
country: United Kingdom
facility: The Royal Marsden NHS Foundation - Sutton
city: London
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust - Chelsea
city: Rhyl
country: United Kingdom
facility: North Wales Cancer Treatment Centre
city: Wirral
country: United Kingdom
facility: The Clatterbridge Cancer Centre NHS Foundation Trust
city: Withington
country: United Kingdom
facility: The Christie NHS Foundation Trust
Study officials:
affiliation: Halozyme Therapeutics
name: VP, Medical, Regulatory and Drug Safety
role: STUDY_DIRECTOR
References: