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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

Primary Purpose

Pancreatic Ductal Carcinoma

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Biological: PEGylated Recombinant Human Hyaluronidase (PEGPH20)
Placebo
nab-Paclitaxel
Gemcitabine
Sponsored by
Halozyme Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Ductal Carcinoma focused on measuring Pancreatic ductal adenocarcinoma (PDA), Pancreatic ductal carcinoma, PEGylated Recombinant Human Hyaluronidase (PEGPH20), Nab-paclitaxel, Gemcitabine, Metastatic, Stage IV

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of South Alabama
  • Banner MD Anderson Cancer Center
  • Highlands Oncology Group
  • St. Jude Hospital Yorba DBA Linda St. Joseph Heritage Health
  • Scripps Clinical Research Services
  • Samuel Oschin Comprehensive Cancer Institute
  • David Geffen School of Medicine (DGSOM) at UCLA
  • Chao Family Comprehensive Cancer Center
  • St. Joseph Hospital
  • Desert Hematology Oncology Medical Group, Inc.
  • Cancer Care Associates Medical Group, Inc.
  • Pacific Hematology Oncology Associates
  • UCSF Helen Diller Family Comprehensive Cancer Center
  • Pacific Central Coast Health Centers: San Luis Obispo Oncology and Hematology Health Center
  • St Joseph Heritage Healthcare
  • Innovative Clinical Research Institution
  • Kaiser Permanente Franklin Medical Offices - Denver
  • US Oncology - Rocky Mountain Cancer Centers - Midtown
  • St. Mary's Medical Center
  • Yale Cancer Center
  • MedStar Georgetown University Hospital
  • Memorial Healthcare System - Memorial Cancer Institute
  • 21st Century Oncology
  • MD Anderson Cancer Center Orlando
  • Fort Wayne Medical Oncology/Hematology, INC.
  • The University Of Kansas Cancer Center
  • University of Louisville
  • Ochsner Health Center
  • Ochsner Clinic CCOP
  • The Sidney Kimmel Comprehensive Cancer Center
  • Beth Israel Deaconess Medical Center
  • UMass Memorial Medical Center
  • University of Michigan Medical Center
  • Karmanos Cancer Institute
  • Virginia Piper Cancer Institute
  • University of Minnesota Medical School
  • Comprehensive Cancer Centers of Nevada
  • Renown Regional Medical Center
  • Dartmouth Hitchcock Medical Center
  • Saint Joseph's Ambulatory Clinic
  • Jersey Shore University Medical Center
  • Northwell Health/Monter Cancer Center
  • NYU Langone Medical Center - NYU Langone Arena Oncology
  • Columbia University Medical Center
  • Mount Sinai School of Medicine - The Tisch Cancer Institute
  • University of Rochester Medical Center
  • Rex Cancer Center
  • Gabrail Cancer Center Research
  • The University of Oklahoma Health Sciences Center
  • Penn State Milton S. Hershey Medical Center
  • Allegheny General Hospital
  • Univ of Pittsburgh Cancer institute
  • Baylor College of Medicine - Baylor Clinic
  • Scott and White
  • University of Utah - Huntsman Cancer Institute
  • Inova Dwight and Martha Schar Cancer Institute
  • Fort Belvoir Community Hospital
  • Virginia Cancer Institute
  • Swedish Cancer Institute/ Swedish Health Services
  • University of Washington (UW) - Seattle Cancer Care Alliance
  • Northwest Medical Specialties PLLC
  • University of Wisconsin Health - UW Carbone Cancer Center
  • Columbia St. Marys
  • Medical College of Wisconsin
  • Bankstown-Lidcombe Hospital
  • Chris O'Brien Lifehouse
  • St Vincent's Hospital
  • Royal North Shore Hospital
  • Flinders Medical Centre
  • Bendigo Health Care Group
  • Monash Health
  • Peninsula & South Eastern Haematology and Oncology Group
  • Imelda Ziekenhuis
  • UZA
  • Cliniques Universitaires Saint-Luc
  • Hôpital Erasme
  • AZ Maria Middelares - Campus Maria Middelares
  • UZ Leuven - Campus Gasthuisberg
  • Centre Hospitalier Universitaire (CHU) de Liege - Domaine Un
  • CENANTRON - Centro Avançado de Tratamento Oncologico
  • Hospital da Cidade de Passo Fundo
  • Hospital de Clinicas de Porto Alegre - UFRGS
  • Hospital São Lucas da PUCRS
  • Occ -Oncologia Clínica De Campinas
  • Fundação Amaral Cravalho / Hospital Amaral Carvalho
  • Fm Abc/ Cepho
  • Faculdade de Medicina da Universidade de Sao Paulo
  • Fundacao Pio XII Hospital De Câncer de Barretos
  • Instituto COI
  • Instituto Nacional de Câncer - INCA
  • Royal Victoria Regional Health Centre
  • Princess Margaret Hospital
  • Klinicki bolnicki centar Zagreb
  • Klinicki bolnički centar Sestre milosrdnice
  • Masarykuv onkologicky ustav
  • FN Hradec Kralove
  • Fakultni nemocnice Olomouc
  • Nemocnice Na Bulovce (Hospital Na Bulovce)
  • Fakultni nemocnice v Motole
  • Odense Universitetshospital
  • East Tallinn Central Hospital Oncology Center
  • North Estonian Medical Centre Foundation Clinic of Oncology
  • Centre Eugene Marquis
  • Hospitalier Jean Minjoz
  • ICM Val d'Aurelle Saint Eloi - Departement Oncologie
  • ICO - Site Ren Gauducheau
  • CHU Estaing
  • Hopital Edouard Herriot
  • Institut De Cancerologie Gustave Roussy
  • Institut de Cancérologie de l'Ouest - Site Paul Papin
  • Hôpital Haut-Leveque
  • Henri Mondor - Albert Chevenier
  • Centre Lyon Berard
  • Hopital Privé Jean Mermoz
  • Institut Mutualiste Montsouris
  • Pitié Salpetriere Hospital
  • Hôpital Beaujon
  • Universitätsklinikum Ulm
  • Klinikum der Universität München - Campus Grosshadern
  • Universitätsklinikum Bonn
  • Uniklinik Köln-Klinik für Gastroenterologie und Hepatologie am Abdominalzentrum
  • Universitätsklinik Carl-Gustav-Carus Dresden
  • Universitätsklinikum Leipzig AöR
  • Charité - Universitätsmedizin Berlin
  • Kliniken Essen-Mitte Evang. Huyssens-Stiftung
  • Universitätsklinikum Halle-Universitätsklinik und Poliklinik
  • Facharztzentrum Eppendorf
  • Universitätskllinikum Heidelberg
  • Pécsi Tudományegyetem Klinikai Központ
  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpo
  • Petz Aladár Megyei Oktató Kórház
  • Debreceni Egyetem Klinikai Központ
  • Egyesített Szent István és Szent László Kórház-Rendelőintéze
  • Magyar Honvédség Egészségügyi Központ
  • Országos Onkológiai Intézet
  • Semmelweis Egyetem - Isz. Bel, Onkológiai Részleg
  • Semmelweis Egyetem - Onkohaematológiai Osztály
  • Szent Margit Kórház
  • Somogy Megyei Kaposi Mór Oktató Kórház
  • Assaf Harofeh Medical Center
  • Meir Medical Center
  • Rabin Medical Center - Beilinson Hospital
  • Tel Aviv Sourasky Medical Center
  • Hadassah Medical Organisation
  • Ha'Emek Medical Center
  • Soroka Medical Center [Oncology]
  • Hillel Yaffe Medical Center
  • Rambam Health Care Campus
  • Shaare Zedek Medical Center
  • The Chaim Sheba Medical Center [Oncology]
  • U.O. di Oncologia
  • Istituto Clinico Humanitas Rozzano, IRCCS
  • PO di Cremona, ASST di Cremona
  • AO S. Martino, IRCCS, IST-Istituto Nazionale Ricerca Sul Cancro
  • IRCCS Ospedale S.Raffaele
  • Ieo, Irccs
  • Istituto Oncologico Veneto IOV-IRCCS
  • Regina Elena, Istituto Nazionale dei Tumori, IFO, IRCCS
  • Borgo Roma, Policlinico G.Rossi, AOU Integrata Verona
  • Dong-A University Hospital
  • Keimyung University Dongsan Medical Center
  • Seoul National University Bundang Hospital
  • Asan Medical Center
  • Korea University Anam Hospital
  • Samsung Medical Center
  • Severance Hospital, Yonsei University Health System
  • The Catholic University of Korea, Seoul St.Mary's Hospital
  • Gachon University Gil Medical Center
  • Korea University Guro Hospital
  • Seoul National University Hospital
  • Daugavpils Regional Hospital
  • P.Stradins Clinical University
  • SIA "Rigas Austrumu Kliniska Universitates Slimnica"
  • National Cancer Institute
  • Vilniaus Universiteto ligonines Santariskiu Klinikos
  • Maastricht University Medical Centre
  • Academisch Medisch Centrum Universiteit van Amsterdam
  • Spaarne Gasthuis
  • Radboud Universiteit Nijmegen
  • Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onko
  • Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
  • Centrum Onkologii Instytut im. M. Sklodowskiej-Curie
  • Institut Català d'Oncologia-Hospital Germans Trias i Pujol
  • Institut Catalá d´Oncología (I.C.O.)
  • H.U. de Fuenlabrada
  • Clínica Universidad de Navarra
  • H.del Mar
  • H.Sta.Creu i St.Pau
  • H.U.Vall d'Hebrón
  • H.C. S.Carlos
  • H.G.U. G. Marañón
  • H.U. F. Jiménez Díaz
  • H.U. R. y Cajal
  • Hospital Madrid Norte Sanchinarro
  • F.I. Valenciano de Oncología
  • Hospital Universitari i Politècnic La Fe
  • H.U. Miguel Servet
  • China Medical University Hospital
  • Changhua Christian Hospital
  • National Cheng Kung University Hospital
  • National Taiwan University Hospital
  • Veterans General Hospital- Taipei
  • Addenbrooke's Hospital, Cambridge
  • Peterborough And Stamford Hospitals
  • Beatson West of Scotland Cancer Centre
  • Sarah Cannon Research Institute UK (SCRI UK)
  • Edinburgh Cancer Centre Western General Hospital
  • The Clatterbridge Cancer Centre NHS Foundation Trust
  • Queen Elizabeth Hospital Birmingham
  • Castle Hill Hospital
  • Coventry Hospital
  • Hammersmith Hospital
  • The Royal Marsden NHS Foundation - Sutton
  • The Royal Marsden NHS Foundation Trust - Chelsea
  • North Wales Cancer Treatment Centre
  • The Clatterbridge Cancer Centre NHS Foundation Trust
  • The Christie NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PAG: PEGPH20 + nab-Paclitaxel + Gemcitabine

AG: Placebo + nab-Paclitaxel + Gemcitabine

Arm Description

Participants 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.

Participants 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.

Outcomes

Primary Outcome Measures

Overall Survival
Overall survival was defined as the time from randomization until death from any cause. Overall survival was analyzed using Kaplan-Meier methods.

Secondary Outcome Measures

Progression-Free Survival (PFS)
PFS was defined as the time from randomization until the first occurrence of radiological disease progression, as determined by the blinded Central Imaging Vendor (CIV) based on Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1, or death from any cause during the treatment period. Disease progression was defined as at least a 20 percent (%) increase in sum of diameters of target lesions, taking as reference the smallest sum on study thus far, nadir (this included baseline sum if that was the smallest on study); Sum must also demonstrate an absolute increase of at least 5 millimeters (mm); Appearance of one or more new lesions; Unequivocal progression of existing non-target lesions. Surviving participants without disease progression were censored for PFS analysis at the date of last evaluable post-baseline tumor assessment. Surviving participants without any post-baseline disease assessment were censored on Day 1. PFS was estimated using Kaplan-Meier method.
Objective Response Rate (ORR): Percentage of Participants With Objective Response
ORR was defined as percentage of participants who achieved either a complete response (CR) or partial response (PR) as determined by the blinded CIV based on RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions; Any pathological or non-pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Duration of Response (DOR)
DOR was defined as the time from the first objective response of CR or PR until disease progression (as determined by the blinded CIV based on RECIST version 1.1) or death within 14 days of last dose of study treatment or randomization. CR was defined as disappearance of all target and non-target lesions; Any pathological or non-pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study thus far, the sum must also demonstrate an absolute increase of at least 5 mm, or the appearance of one or more new lesions; and unequivocal progression of existing non-target lesions. DOR was analyzed using Kaplan-Meier methods.
Number of Participants With Treatment-Emergent Adverse Events (AEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were defined as AEs that begin or worsen in severity during or after the participant's first dose of study treatment and no later than 30 days after the date of the last dose of study treatment and/or any treatment-related AE regardless of the onset date. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.
Number of Participants With Worst Post-Baseline Hematology and Chemistry (Clinical Laboratory Parameters) Severity Grade During the Study
Severity grade associated with a laboratory parameter value was determined using Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03. Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life-threatening. Grade 0 indicates evaluable lab records but not fall into any CTCAE grade for certain CTCAE term. A worst post-baseline grade shift was defined as the worst change that occurred at any measured timepoint during study. Hematology abnormalities: anemia(hemoglobin decreased), lymphocyte count decreased, lymphocyte count increased, neutropenia(neutrophil count decreased), thrombocytopenia(platelet count decreased), and leukopenia(white blood cell decreased). Chemistry abnormalities: hypoalbuminemia, alkaline phosphatase increased, alanine aminotransferase increased, aspartate aminotransferase increased, hyperbilirubinemia, hypo- and hypercalcemia, creatinine increased, hypo- and hyperglycaemia, hypo- and hyperkalemia, hypo- and hypermagnesemia, hypo- and hypernatremia.
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG)
ECGs including clinical significance was evaluated by the Investigator. Criteria for clinical significance were as per investigator's discretion.
Number of Participants With Clinically Significant Abnormalities in Vital Signs
Vital signs included measurement of blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]), heart rate, and body weight. Criteria for clinical significance abnormalities were: Heart rate: <50 beats per minute (bpm), >120 bpm, >=30 bpm increase from baseline, >=30 bpm decrease from baseline. SBP: >140 millimeters of mercury (mmHg) and increase from baseline >20 mmHg, >180 mmHg, <90 mmHg and decrease from baseline >10 mmHg. DBP: >90 mmHg and increase from baseline >20 mmHg, >105 mmHg, <60 mmHg and decrease from baseline >10 mmHg. Change in weight: >=5% increase from baseline, >=5% decrease from baseline.

Full Information

First Posted
March 17, 2016
Last Updated
June 30, 2020
Sponsor
Halozyme Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT02715804
Brief Title
A Study of PEGylated Recombinant Human Hyaluronidase in Combination With Nab-Paclitaxel Plus Gemcitabine Compared With Placebo Plus Nab-Paclitaxel and Gemcitabine in Participants With Hyaluronan-High Stage IV Previously Untreated Pancreatic Ductal Adenocarcinoma
Official Title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) in Combination With Nab-Paclitaxel Plus Gemcitabine Compared With Placebo Plus Nab-Paclitaxel and Gemcitabine in Subjects With Hyaluronan-High Stage IV Previously Untreated Pancreatic Ductal Adenocarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decision
Study Start Date
March 14, 2016 (Actual)
Primary Completion Date
November 4, 2019 (Actual)
Study Completion Date
November 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Halozyme Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to compare the efficacy and safety of PEGylated Recombinant Human Hyaluronidase (PEGPH20) combined with nab-paclitaxel plus gemcitabine (PAG treatment), compared with placebo combined with nab-paclitaxel plus gemcitabine (AG treatment), in participants with hyaluronan (HA)-high Stage IV previously untreated pancreatic ductal adenocarcinoma (PDA).
Detailed Description
Participants will be randomized in a 2:1 ratio to PAG or AG treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Ductal Carcinoma
Keywords
Pancreatic ductal adenocarcinoma (PDA), Pancreatic ductal carcinoma, PEGylated Recombinant Human Hyaluronidase (PEGPH20), Nab-paclitaxel, Gemcitabine, Metastatic, Stage IV

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
492 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PAG: PEGPH20 + nab-Paclitaxel + Gemcitabine
Arm Type
Experimental
Arm Description
Participants 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.
Arm Title
AG: Placebo + nab-Paclitaxel + Gemcitabine
Arm Type
Placebo Comparator
Arm Description
Participants 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.
Intervention Type
Other
Intervention Name(s)
Biological: PEGylated Recombinant Human Hyaluronidase (PEGPH20)
Intervention Description
PEGPH20 will be administered as per the dose and schedule specified in the respective arms.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo for PEGPH20
Intervention Type
Drug
Intervention Name(s)
nab-Paclitaxel
Other Intervention Name(s)
Abraxane®
Intervention Description
Nab-paclitaxel will be administered as per the dose and schedule specified in the respective arms.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Gemzar®
Intervention Description
Gemcitabine will be administered as per the dose and schedule specified in the respective arms.
Primary Outcome Measure Information:
Title
Overall Survival
Description
Overall survival was defined as the time from randomization until death from any cause. Overall survival was analyzed using Kaplan-Meier methods.
Time Frame
From randomization until death from any cause (maximum exposure: 150.1 weeks for PAG, and 83.9 weeks for AG)
Secondary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
PFS was defined as the time from randomization until the first occurrence of radiological disease progression, as determined by the blinded Central Imaging Vendor (CIV) based on Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1, or death from any cause during the treatment period. Disease progression was defined as at least a 20 percent (%) increase in sum of diameters of target lesions, taking as reference the smallest sum on study thus far, nadir (this included baseline sum if that was the smallest on study); Sum must also demonstrate an absolute increase of at least 5 millimeters (mm); Appearance of one or more new lesions; Unequivocal progression of existing non-target lesions. Surviving participants without disease progression were censored for PFS analysis at the date of last evaluable post-baseline tumor assessment. Surviving participants without any post-baseline disease assessment were censored on Day 1. PFS was estimated using Kaplan-Meier method.
Time Frame
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)
Title
Objective Response Rate (ORR): Percentage of Participants With Objective Response
Description
ORR was defined as percentage of participants who achieved either a complete response (CR) or partial response (PR) as determined by the blinded CIV based on RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions; Any pathological or non-pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Time Frame
From the date of randomization until CR or PR (maximum exposure: 150.1 weeks for PAG, and 83.9 weeks for AG)
Title
Duration of Response (DOR)
Description
DOR was defined as the time from the first objective response of CR or PR until disease progression (as determined by the blinded CIV based on RECIST version 1.1) or death within 14 days of last dose of study treatment or randomization. CR was defined as disappearance of all target and non-target lesions; Any pathological or non-pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study thus far, the sum must also demonstrate an absolute increase of at least 5 mm, or the appearance of one or more new lesions; and unequivocal progression of existing non-target lesions. DOR was analyzed using Kaplan-Meier methods.
Time Frame
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)
Title
Number of Participants With Treatment-Emergent Adverse Events (AEs)
Description
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were defined as AEs that begin or worsen in severity during or after the participant's first dose of study treatment and no later than 30 days after the date of the last dose of study treatment and/or any treatment-related AE regardless of the onset date. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.
Time Frame
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)
Title
Number of Participants With Worst Post-Baseline Hematology and Chemistry (Clinical Laboratory Parameters) Severity Grade During the Study
Description
Severity grade associated with a laboratory parameter value was determined using Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03. Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life-threatening. Grade 0 indicates evaluable lab records but not fall into any CTCAE grade for certain CTCAE term. A worst post-baseline grade shift was defined as the worst change that occurred at any measured timepoint during study. Hematology abnormalities: anemia(hemoglobin decreased), lymphocyte count decreased, lymphocyte count increased, neutropenia(neutrophil count decreased), thrombocytopenia(platelet count decreased), and leukopenia(white blood cell decreased). Chemistry abnormalities: hypoalbuminemia, alkaline phosphatase increased, alanine aminotransferase increased, aspartate aminotransferase increased, hyperbilirubinemia, hypo- and hypercalcemia, creatinine increased, hypo- and hyperglycaemia, hypo- and hyperkalemia, hypo- and hypermagnesemia, hypo- and hypernatremia.
Time Frame
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)
Title
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG)
Description
ECGs including clinical significance was evaluated by the Investigator. Criteria for clinical significance were as per investigator's discretion.
Time Frame
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)
Title
Number of Participants With Clinically Significant Abnormalities in Vital Signs
Description
Vital signs included measurement of blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]), heart rate, and body weight. Criteria for clinical significance abnormalities were: Heart rate: <50 beats per minute (bpm), >120 bpm, >=30 bpm increase from baseline, >=30 bpm decrease from baseline. SBP: >140 millimeters of mercury (mmHg) and increase from baseline >20 mmHg, >180 mmHg, <90 mmHg and decrease from baseline >10 mmHg. DBP: >90 mmHg and increase from baseline >20 mmHg, >105 mmHg, <60 mmHg and decrease from baseline >10 mmHg. Change in weight: >=5% increase from baseline, >=5% decrease from baseline.
Time Frame
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Participants must satisfy all the following inclusion criteria to be enrolled in the study: 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). Serum creatinine ≤2.0 milligrams/deciliter (mg/dL) or calculated creatinine clearance ≥40 milliliters/minute (mL/min). Serum albumin ≥2.5 grams/deciliter (g/dL). 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. Partial thromboplastin time (PTT) within normal limits (±15%). Hemoglobin ≥9 g/dL (transfusion and erythropoietic agents allowed). Absolute neutrophil count ≥1,500 cells/cubic millimeter (cells/mm^3). Platelet count ≥100,000/mm^3. 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: 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. 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. 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. Immunization with a live vaccine up to 2 weeks prior to Day 1. Hypersensitivity to the active substance or ingredients of PEGPH20, gemcitabine, and nab-paclitaxel. Inability to comply with study and follow-up procedures as judged by the Investigator.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
VP, Medical, Regulatory and Drug Safety
Organizational Affiliation
Halozyme Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
University of South Alabama
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
Country
United States
Facility Name
Banner MD Anderson Cancer Center
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234-2165
Country
United States
Facility Name
Highlands Oncology Group
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
Facility Name
St. Jude Hospital Yorba DBA Linda St. Joseph Heritage Health
City
Fullerton
State/Province
California
ZIP/Postal Code
92886
Country
United States
Facility Name
Scripps Clinical Research Services
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Samuel Oschin Comprehensive Cancer Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
David Geffen School of Medicine (DGSOM) at UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Chao Family Comprehensive Cancer Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
St. Joseph Hospital
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Desert Hematology Oncology Medical Group, Inc.
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
Cancer Care Associates Medical Group, Inc.
City
Redondo Beach
State/Province
California
ZIP/Postal Code
90277
Country
United States
Facility Name
Pacific Hematology Oncology Associates
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
UCSF Helen Diller Family Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Pacific Central Coast Health Centers: San Luis Obispo Oncology and Hematology Health Center
City
San Luis Obispo
State/Province
California
ZIP/Postal Code
93401
Country
United States
Facility Name
St Joseph Heritage Healthcare
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95405
Country
United States
Facility Name
Innovative Clinical Research Institution
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Facility Name
Kaiser Permanente Franklin Medical Offices - Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
80205
Country
United States
Facility Name
US Oncology - Rocky Mountain Cancer Centers - Midtown
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
St. Mary's Medical Center
City
Grand Junction
State/Province
Colorado
ZIP/Postal Code
81501
Country
United States
Facility Name
Yale Cancer Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
MedStar Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Memorial Healthcare System - Memorial Cancer Institute
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
21st Century Oncology
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
MD Anderson Cancer Center Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Fort Wayne Medical Oncology/Hematology, INC.
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46845
Country
United States
Facility Name
The University Of Kansas Cancer Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40292
Country
United States
Facility Name
Ochsner Health Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Ochsner Clinic CCOP
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70119
Country
United States
Facility Name
The Sidney Kimmel Comprehensive Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
UMass Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
University of Michigan Medical Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Virginia Piper Cancer Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
University of Minnesota Medical School
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
Renown Regional Medical Center
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03743
Country
United States
Facility Name
Saint Joseph's Ambulatory Clinic
City
Clifton
State/Province
New Jersey
ZIP/Postal Code
07013
Country
United States
Facility Name
Jersey Shore University Medical Center
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07753
Country
United States
Facility Name
Northwell Health/Monter Cancer Center
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
NYU Langone Medical Center - NYU Langone Arena Oncology
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
Mount Sinai School of Medicine - The Tisch Cancer Institute
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Rex Cancer Center
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Gabrail Cancer Center Research
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
The University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Univ of Pittsburgh Cancer institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Baylor College of Medicine - Baylor Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Scott and White
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
University of Utah - Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84103
Country
United States
Facility Name
Inova Dwight and Martha Schar Cancer Institute
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Fort Belvoir Community Hospital
City
Fort Belvoir
State/Province
Virginia
ZIP/Postal Code
22060
Country
United States
Facility Name
Virginia Cancer Institute
City
Mechanicsville
State/Province
Virginia
ZIP/Postal Code
23116
Country
United States
Facility Name
Swedish Cancer Institute/ Swedish Health Services
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
University of Washington (UW) - Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Northwest Medical Specialties PLLC
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
University of Wisconsin Health - UW Carbone Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Columbia St. Marys
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53211
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Bankstown-Lidcombe Hospital
City
Bankstown
State/Province
New South Wales
Country
Australia
Facility Name
Chris O'Brien Lifehouse
City
Camperdown
State/Province
New South Wales
Country
Australia
Facility Name
St Vincent's Hospital
City
Darlinghurst
State/Province
New South Wales
Country
Australia
Facility Name
Royal North Shore Hospital
City
St Leonards
State/Province
New South Wales
Country
Australia
Facility Name
Flinders Medical Centre
City
Bedford
State/Province
South Australia
Country
Australia
Facility Name
Bendigo Health Care Group
City
Bendigo
State/Province
Victoria
Country
Australia
Facility Name
Monash Health
City
Bentleigh East
State/Province
Victoria
Country
Australia
Facility Name
Peninsula & South Eastern Haematology and Oncology Group
City
Frankston
State/Province
Victoria
Country
Australia
Facility Name
Imelda Ziekenhuis
City
Bonheiden
State/Province
Antwerpen
Country
Belgium
Facility Name
UZA
City
Edegem
State/Province
Antwerpen
Country
Belgium
Facility Name
Cliniques Universitaires Saint-Luc
City
Brussels
State/Province
Brussels Capital Region
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Hôpital Erasme
City
Bruxelles
State/Province
Brussels Capital Region
Country
Belgium
Facility Name
AZ Maria Middelares - Campus Maria Middelares
City
Gent
State/Province
Oost-Vlaanderen
Country
Belgium
Facility Name
UZ Leuven - Campus Gasthuisberg
City
Leuven
State/Province
Vlaams Brabant
Country
Belgium
Facility Name
Centre Hospitalier Universitaire (CHU) de Liege - Domaine Un
City
Liege
Country
Belgium
Facility Name
CENANTRON - Centro Avançado de Tratamento Oncologico
City
Belo Horizonte
State/Province
Minas Gerais
Country
Brazil
Facility Name
Hospital da Cidade de Passo Fundo
City
Passo Fundo
State/Province
Rio Grande Do Sul
Country
Brazil
Facility Name
Hospital de Clinicas de Porto Alegre - UFRGS
City
Porto Alegre
State/Province
Rio Grande Do Sul
Country
Brazil
Facility Name
Hospital São Lucas da PUCRS
City
Porto Alegre
State/Province
Rio Grande Do Sul
Country
Brazil
Facility Name
Occ -Oncologia Clínica De Campinas
City
Campinas
State/Province
São Paulo
Country
Brazil
Facility Name
Fundação Amaral Cravalho / Hospital Amaral Carvalho
City
Jaú
State/Province
São Paulo
Country
Brazil
Facility Name
Fm Abc/ Cepho
City
Santo Andre
State/Province
São Paulo
Country
Brazil
Facility Name
Faculdade de Medicina da Universidade de Sao Paulo
City
Sao Paulo
State/Province
São Paulo
Country
Brazil
Facility Name
Fundacao Pio XII Hospital De Câncer de Barretos
City
Barretos
Country
Brazil
Facility Name
Instituto COI
City
Rio de Janeiro
Country
Brazil
Facility Name
Instituto Nacional de Câncer - INCA
City
Rio de Janeiro
Country
Brazil
Facility Name
Royal Victoria Regional Health Centre
City
Barrie
State/Province
Ontario
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Klinicki bolnicki centar Zagreb
City
Zagreb
State/Province
Grad Zagreb
Country
Croatia
Facility Name
Klinicki bolnički centar Sestre milosrdnice
City
Zagreb
Country
Croatia
Facility Name
Masarykuv onkologicky ustav
City
Brno
State/Province
Brno-město
Country
Czechia
Facility Name
FN Hradec Kralove
City
Hradec Kralove
State/Province
Královéhradecký Kraj
Country
Czechia
Facility Name
Fakultni nemocnice Olomouc
City
Olomouc
State/Province
Olomoucký Kraj
Country
Czechia
Facility Name
Nemocnice Na Bulovce (Hospital Na Bulovce)
City
Prague
Country
Czechia
Facility Name
Fakultni nemocnice v Motole
City
Praha 5
Country
Czechia
Facility Name
Odense Universitetshospital
City
Odense
State/Province
South Denmark
Country
Denmark
Facility Name
East Tallinn Central Hospital Oncology Center
City
Tallinn
State/Province
Harjumaa
Country
Estonia
Facility Name
North Estonian Medical Centre Foundation Clinic of Oncology
City
Tallinn
State/Province
Harjumaa
Country
Estonia
Facility Name
Centre Eugene Marquis
City
Rennes Cedex
State/Province
Bretagne
Country
France
Facility Name
Hospitalier Jean Minjoz
City
Besançon cedex
State/Province
Franche-Comté
Country
France
Facility Name
ICM Val d'Aurelle Saint Eloi - Departement Oncologie
City
Montpellier
State/Province
Hérault
Country
France
Facility Name
ICO - Site Ren Gauducheau
City
Saint Herblain
State/Province
Loire-Atlantique
Country
France
Facility Name
CHU Estaing
City
Clermont-Ferrand
State/Province
Puy-de-Dôme
Country
France
Facility Name
Hopital Edouard Herriot
City
Lyon Cedex 03
State/Province
Rhône
Country
France
Facility Name
Institut De Cancerologie Gustave Roussy
City
Villejuif
State/Province
Val-de-Marne
Country
France
Facility Name
Institut de Cancérologie de l'Ouest - Site Paul Papin
City
Angers Cedex 02
Country
France
Facility Name
Hôpital Haut-Leveque
City
Bordeaux
Country
France
Facility Name
Henri Mondor - Albert Chevenier
City
Créteil
Country
France
Facility Name
Centre Lyon Berard
City
Lyon Cedex
Country
France
Facility Name
Hopital Privé Jean Mermoz
City
Lyon
Country
France
Facility Name
Institut Mutualiste Montsouris
City
Paris
Country
France
Facility Name
Pitié Salpetriere Hospital
City
Paris
Country
France
Facility Name
Hôpital Beaujon
City
Clichy Cedex
State/Province
Île-de-France
Country
France
Facility Name
Universitätsklinikum Ulm
City
Ulm
State/Province
Baden-Württemberg
Country
Germany
Facility Name
Klinikum der Universität München - Campus Grosshadern
City
München
State/Province
Bayern
Country
Germany
Facility Name
Universitätsklinikum Bonn
City
Bonn
State/Province
Nordrhein-Westfalen
Country
Germany
Facility Name
Uniklinik Köln-Klinik für Gastroenterologie und Hepatologie am Abdominalzentrum
City
Koeln
State/Province
Nordrhein-Westfalen
Country
Germany
Facility Name
Universitätsklinik Carl-Gustav-Carus Dresden
City
Dresden
State/Province
Sachsen
Country
Germany
Facility Name
Universitätsklinikum Leipzig AöR
City
Leipzig
State/Province
Sachsen
Country
Germany
Facility Name
Charité - Universitätsmedizin Berlin
City
Berlin
Country
Germany
Facility Name
Kliniken Essen-Mitte Evang. Huyssens-Stiftung
City
Essen
Country
Germany
Facility Name
Universitätsklinikum Halle-Universitätsklinik und Poliklinik
City
Halle
Country
Germany
Facility Name
Facharztzentrum Eppendorf
City
Hamburg
Country
Germany
Facility Name
Universitätskllinikum Heidelberg
City
Heidelberg
Country
Germany
Facility Name
Pécsi Tudományegyetem Klinikai Központ
City
Pécs
State/Province
Baranya
Country
Hungary
Facility Name
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpo
City
Szeged
State/Province
Csongrád
Country
Hungary
Facility Name
Petz Aladár Megyei Oktató Kórház
City
Győr
State/Province
Gyor-Moson-Sopron
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Központ
City
Debrecen
State/Province
Hajdú-Bihar
Country
Hungary
Facility Name
Egyesített Szent István és Szent László Kórház-Rendelőintéze
City
Budapest
Country
Hungary
Facility Name
Magyar Honvédség Egészségügyi Központ
City
Budapest
Country
Hungary
Facility Name
Országos Onkológiai Intézet
City
Budapest
Country
Hungary
Facility Name
Semmelweis Egyetem - Isz. Bel, Onkológiai Részleg
City
Budapest
Country
Hungary
Facility Name
Semmelweis Egyetem - Onkohaematológiai Osztály
City
Budapest
Country
Hungary
Facility Name
Szent Margit Kórház
City
Budapest
Country
Hungary
Facility Name
Somogy Megyei Kaposi Mór Oktató Kórház
City
Kaposvár
Country
Hungary
Facility Name
Assaf Harofeh Medical Center
City
Be'er Ya'aqov
State/Province
HaMerkaz
Country
Israel
Facility Name
Meir Medical Center
City
Kfar-Saba
State/Province
HaMerkaz
Country
Israel
Facility Name
Rabin Medical Center - Beilinson Hospital
City
Petah Tikva
State/Province
HaMerkaz
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
State/Province
Tel-Aviv
Country
Israel
Facility Name
Hadassah Medical Organisation
City
Jerusalem
State/Province
Yerushalayim
Country
Israel
Facility Name
Ha'Emek Medical Center
City
Afula
Country
Israel
Facility Name
Soroka Medical Center [Oncology]
City
Beer Sheva
Country
Israel
Facility Name
Hillel Yaffe Medical Center
City
Hadera
Country
Israel
Facility Name
Rambam Health Care Campus
City
Haifa
Country
Israel
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
Country
Israel
Facility Name
The Chaim Sheba Medical Center [Oncology]
City
Tel Hashomer
Country
Israel
Facility Name
U.O. di Oncologia
City
San Giovanni Rotondo
State/Province
Foggia
Country
Italy
Facility Name
Istituto Clinico Humanitas Rozzano, IRCCS
City
Rozzano
State/Province
Milano
Country
Italy
Facility Name
PO di Cremona, ASST di Cremona
City
Cremona
Country
Italy
Facility Name
AO S. Martino, IRCCS, IST-Istituto Nazionale Ricerca Sul Cancro
City
Genova
Country
Italy
Facility Name
IRCCS Ospedale S.Raffaele
City
Milano
Country
Italy
Facility Name
Ieo, Irccs
City
Milan
Country
Italy
Facility Name
Istituto Oncologico Veneto IOV-IRCCS
City
Padova
Country
Italy
Facility Name
Regina Elena, Istituto Nazionale dei Tumori, IFO, IRCCS
City
Roma
Country
Italy
Facility Name
Borgo Roma, Policlinico G.Rossi, AOU Integrata Verona
City
Verona
Country
Italy
Facility Name
Dong-A University Hospital
City
Busan
State/Province
Busan Gwang'yeogsi
Country
Korea, Republic of
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu
State/Province
Daegu Gwang'yeogsi
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggido
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
State/Province
Seoul Teugbyeolsi
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
State/Province
Seoul Teugbyeolsi
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
State/Province
Seoul Teugbyeolsi
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
State/Province
Seoul Teugbyeolsi
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Seoul St.Mary's Hospital
City
Seoul
State/Province
Seoul Teugbyeolsi
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center
City
Incheon
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Daugavpils Regional Hospital
City
Daugavpils
Country
Latvia
Facility Name
P.Stradins Clinical University
City
Riga
Country
Latvia
Facility Name
SIA "Rigas Austrumu Kliniska Universitates Slimnica"
City
Riga
Country
Latvia
Facility Name
National Cancer Institute
City
Vilnius
State/Province
Vilniaus Apskritis
Country
Lithuania
Facility Name
Vilniaus Universiteto ligonines Santariskiu Klinikos
City
Vilnius
State/Province
Vilniaus Apskritis
Country
Lithuania
Facility Name
Maastricht University Medical Centre
City
Maastricht
State/Province
Limburg
Country
Netherlands
Facility Name
Academisch Medisch Centrum Universiteit van Amsterdam
City
Amsterdam
Country
Netherlands
Facility Name
Spaarne Gasthuis
City
Hoofddorp
Country
Netherlands
Facility Name
Radboud Universiteit Nijmegen
City
Nijmegen
Country
Netherlands
Facility Name
Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onko
City
Brzozow
State/Province
Podkarpackie
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
City
Lublin
Country
Poland
Facility Name
Centrum Onkologii Instytut im. M. Sklodowskiej-Curie
City
Warszawa
Country
Poland
Facility Name
Institut Català d'Oncologia-Hospital Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
Country
Spain
Facility Name
Institut Catalá d´Oncología (I.C.O.)
City
L'Hospitalet De Llobregat
State/Province
Barcelona
Country
Spain
Facility Name
H.U. de Fuenlabrada
City
Fuenlabrada
State/Province
Madrid
Country
Spain
Facility Name
Clínica Universidad de Navarra
City
Pamplona
State/Province
Navarra
Country
Spain
Facility Name
H.del Mar
City
Barcelona
Country
Spain
Facility Name
H.Sta.Creu i St.Pau
City
Barcelona
Country
Spain
Facility Name
H.U.Vall d'Hebrón
City
Barcelona
Country
Spain
Facility Name
H.C. S.Carlos
City
Madrid
Country
Spain
Facility Name
H.G.U. G. Marañón
City
Madrid
Country
Spain
Facility Name
H.U. F. Jiménez Díaz
City
Madrid
Country
Spain
Facility Name
H.U. R. y Cajal
City
Madrid
Country
Spain
Facility Name
Hospital Madrid Norte Sanchinarro
City
Madrid
Country
Spain
Facility Name
F.I. Valenciano de Oncología
City
Valencia
Country
Spain
Facility Name
Hospital Universitari i Politècnic La Fe
City
Valencia
Country
Spain
Facility Name
H.U. Miguel Servet
City
Zaragoza
Country
Spain
Facility Name
China Medical University Hospital
City
Taichung
State/Province
Taichung Municipality
Country
Taiwan
Facility Name
Changhua Christian Hospital
City
Changhua
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Facility Name
Veterans General Hospital- Taipei
City
Taipei
Country
Taiwan
Facility Name
Addenbrooke's Hospital, Cambridge
City
Cambridge
State/Province
Cambridgeshire
Country
United Kingdom
Facility Name
Peterborough And Stamford Hospitals
City
Peterborough
State/Province
Cambridgeshire
Country
United Kingdom
Facility Name
Beatson West of Scotland Cancer Centre
City
Glasgow
State/Province
Glasgow City
Country
United Kingdom
Facility Name
Sarah Cannon Research Institute UK (SCRI UK)
City
London
State/Province
London, City Of
Country
United Kingdom
Facility Name
Edinburgh Cancer Centre Western General Hospital
City
Edinburgh
State/Province
Midlothian
Country
United Kingdom
Facility Name
The Clatterbridge Cancer Centre NHS Foundation Trust
City
Birkenhead
State/Province
Wirral
Country
United Kingdom
Facility Name
Queen Elizabeth Hospital Birmingham
City
Birmingham
Country
United Kingdom
Facility Name
Castle Hill Hospital
City
Cottingham
Country
United Kingdom
Facility Name
Coventry Hospital
City
Coventry
Country
United Kingdom
Facility Name
Hammersmith Hospital
City
London
Country
United Kingdom
Facility Name
The Royal Marsden NHS Foundation - Sutton
City
London
Country
United Kingdom
Facility Name
The Royal Marsden NHS Foundation Trust - Chelsea
City
London
Country
United Kingdom
Facility Name
North Wales Cancer Treatment Centre
City
Rhyl
Country
United Kingdom
Facility Name
The Clatterbridge Cancer Centre NHS Foundation Trust
City
Wirral
Country
United Kingdom
Facility Name
The Christie NHS Foundation Trust
City
Withington
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

A Study of PEGylated Recombinant Human Hyaluronidase in Combination With Nab-Paclitaxel Plus Gemcitabine Compared With Placebo Plus Nab-Paclitaxel and Gemcitabine in Participants With Hyaluronan-High Stage IV Previously Untreated Pancreatic Ductal Adenocarcinoma

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