AzTrials
AzTrials

Pancreatic Ductal CarcinomaPhase 3NCT02715804

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

A Phase 3 study testing Biological: PEGylated Recombinant Human Hyaluronidase (PEGPH20), nab-Paclitaxel and Gemcitabine in people with Pancreatic Ductal Carcinoma, run by Halozyme Therapeutics at 217 sites in 22 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Ductal Carcinoma
What is being tested?
Biological: PEGylated Recombinant Human Hyaluronidase (PEGPH20), nab-Paclitaxel and Gemcitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
492 participants
Where
217 sitesin 22 countries
Study dates
14 Mar 2016to 4 Nov 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

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

Trial locations and contacts

217 sites in 22 countries.

217 sites in 22 countries

United States64 sites

  • University of Michigan Medical Center

    Ann Arbor, Michigan, 48109

  • The Sidney Kimmel Comprehensive Cancer Center

    Baltimore, Maryland, 21224

  • Ochsner Health Center

    Baton Rouge, Louisiana, 70809

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Gabrail Cancer Center Research

    Canton, Ohio, 44718

  • Saint Joseph's Ambulatory Clinic

    Clifton, New Jersey, 07013

  • Kaiser Permanente Franklin Medical Offices - Denver

    Denver, Colorado, 80205

  • US Oncology - Rocky Mountain Cancer Centers - Midtown

    Denver, Colorado, 80218

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Inova Dwight and Martha Schar Cancer Institute

    Fairfax, Virginia, 22031

  • Highlands Oncology Group

    Fayetteville, Arkansas, 72703

  • Fort Belvoir Community Hospital

    Fort Belvoir, Virginia, 22060

  • Fort Wayne Medical Oncology/Hematology, INC.

    Fort Wayne, Indiana, 46845

  • St. Jude Hospital Yorba DBA Linda St. Joseph Heritage Health

    Fullerton, California, 92886

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234-2165

  • St. Mary's Medical Center

    Grand Junction, Colorado, 81501

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Memorial Healthcare System - Memorial Cancer Institute

    Hollywood, Florida, 33021

  • Baylor College of Medicine - Baylor Clinic

    Houston, Texas, 77030

  • 21st Century Oncology

    Jacksonville, Florida, 32207

  • The University Of Kansas Cancer Center

    Kansas City, Kansas, 66160

  • Scripps Clinical Research Services

    La Jolla, California, 92037

  • Northwell Health/Monter Cancer Center

    Lake Success, New York, 11042

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03743

  • Samuel Oschin Comprehensive Cancer Institute

    Los Angeles, California, 90048

  • David Geffen School of Medicine (DGSOM) at UCLA

    Los Angeles, California, 90095

  • University of Louisville

    Louisville, Kentucky, 40292

  • University of Wisconsin Health - UW Carbone Cancer Center

    Madison, Wisconsin, 53792

  • Virginia Cancer Institute

    Mechanicsville, Virginia, 23116

  • Columbia St. Marys

    Milwaukee, Wisconsin, 53211

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Virginia Piper Cancer Institute

    Minneapolis, Minnesota, 55404

  • University of Minnesota Medical School

    Minneapolis, Minnesota, 55455

  • University of South Alabama

    Mobile, Alabama, 36604

  • Jersey Shore University Medical Center

    Neptune City, New Jersey, 07753

  • Yale Cancer Center

    New Haven, Connecticut, 06510

  • NYU Langone Medical Center - NYU Langone Arena Oncology

    New Hyde Park, New York, 10016

  • Ochsner Clinic CCOP

    New Orleans, Louisiana, 70119

  • Columbia University Medical Center

    New York, New York, 10019

  • Mount Sinai School of Medicine - The Tisch Cancer Institute

    New York, New York, 10029

  • The University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Chao Family Comprehensive Cancer Center

    Orange, California, 92868

  • St. Joseph Hospital

    Orange, California, 92868

  • MD Anderson Cancer Center Orlando

    Orlando, Florida, 32806

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • Univ of Pittsburgh Cancer institute

    Pittsburgh, Pennsylvania, 15232

  • Rex Cancer Center

    Raleigh, North Carolina, 27607

  • Desert Hematology Oncology Medical Group, Inc.

    Rancho Mirage, California, 92270

  • Cancer Care Associates Medical Group, Inc.

    Redondo Beach, California, 90277

  • Renown Regional Medical Center

    Reno, Nevada, 89502

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • University of Utah - Huntsman Cancer Institute

    Salt Lake City, Utah, 84103

  • Pacific Hematology Oncology Associates

    San Francisco, California, 94115

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94115

  • Pacific Central Coast Health Centers: San Luis Obispo Oncology and Hematology Health Center

    San Luis Obispo, California, 93401

  • St Joseph Heritage Healthcare

    Santa Rosa, California, 95405

  • Swedish Cancer Institute/ Swedish Health Services

    Seattle, Washington, 98104

  • University of Washington (UW) - Seattle Cancer Care Alliance

    Seattle, Washington, 98195

  • Northwest Medical Specialties PLLC

    Tacoma, Washington, 98405

  • Scott and White

    Temple, Texas, 76508

  • MedStar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

  • Innovative Clinical Research Institution

    Whittier, California, 90603

  • UMass Memorial Medical Center

    Worcester, Massachusetts, 01605

Other trials in United States

France15 sites

  • Institut de Cancérologie de l'Ouest - Site Paul Papin

    Angers

  • Hospitalier Jean Minjoz

    Besançon, Franche-Comté

  • Hôpital Haut-Leveque

    Bordeaux

  • CHU Estaing

    Clermont-Ferrand, Puy-de-Dôme

  • Hôpital Beaujon

    Clichy, Île-de-France Region

  • Henri Mondor - Albert Chevenier

    Créteil

  • Hopital Edouard Herriot

    Lyon, Rhône

  • Centre Lyon Berard

    Lyon

  • Hopital Privé Jean Mermoz

    Lyon

  • ICM Val d'Aurelle Saint Eloi - Departement Oncologie

    Montpellier, Hérault

  • Institut Mutualiste Montsouris

    Paris

  • Pitié Salpetriere Hospital

    Paris

  • Centre Eugene Marquis

    Rennes, Brittany Region

  • ICO - Site Ren Gauducheau

    Saint-Herblain, Loire-Atlantique

  • Institut De Cancerologie Gustave Roussy

    Villejuif, Val-de-Marne

Other trials in France

Spain15 sites

  • Institut Català d'Oncologia-Hospital Germans Trias i Pujol

    Badalona, Barcelona

  • H.del Mar

    Barcelona

  • H.Sta.Creu i St.Pau

    Barcelona

  • H.U.Vall d'Hebrón

    Barcelona

  • H.U. de Fuenlabrada

    Fuenlabrada, Madrid

  • Institut Catalá d´Oncología (I.C.O.)

    L'Hospitalet de Llobregat, Barcelona

  • H.C. S.Carlos

    Madrid

  • H.G.U. G. Marañón

    Madrid

  • H.U. F. Jiménez Díaz

    Madrid

  • H.U. R. y Cajal

    Madrid

  • Hospital Madrid Norte Sanchinarro

    Madrid

  • Clínica Universidad de Navarra

    Pamplona, Navarre

  • F.I. Valenciano de Oncología

    Valencia

  • Hospital Universitari i Politècnic La Fe

    Valencia

  • H.U. Miguel Servet

    Zaragoza

Other trials in Spain

United Kingdom15 sites

  • The Clatterbridge Cancer Centre NHS Foundation Trust

    Birkenhead, Wirral

  • Queen Elizabeth Hospital Birmingham

    Birmingham

  • Addenbrooke's Hospital, Cambridge

    Cambridge, Cambridgeshire

  • Castle Hill Hospital

    Cottingham

  • Coventry Hospital

    Coventry

  • Edinburgh Cancer Centre Western General Hospital

    Edinburgh, Midlothian

  • Beatson West of Scotland Cancer Centre

    Glasgow, Glasgow City

  • Sarah Cannon Research Institute UK (SCRI UK)

    London, London, City of

  • Hammersmith Hospital

    London

  • The Royal Marsden NHS Foundation - Sutton

    London

  • The Royal Marsden NHS Foundation Trust - Chelsea

    London

  • The Clatterbridge Cancer Centre NHS Foundation Trust

    Metropolitan Borough of Wirral

  • Peterborough And Stamford Hospitals

    Peterborough, Cambridgeshire

  • North Wales Cancer Treatment Centre

    Rhyl

  • The Christie NHS Foundation Trust

    Withington

Other trials in United Kingdom

Brazil11 sites

  • Fundacao Pio XII Hospital De Câncer de Barretos

    Barretos

  • CENANTRON - Centro Avançado de Tratamento Oncologico

    Belo Horizonte, Minas Gerais

  • Occ -Oncologia Clínica De Campinas

    Campinas, São Paulo

  • Fundação Amaral Cravalho / Hospital Amaral Carvalho

    Jaú, São Paulo

  • Hospital da Cidade de Passo Fundo

    Passo Fundo, Rio Grande do Sul

  • Hospital de Clinicas de Porto Alegre - UFRGS

    Porto Alegre, Rio Grande do Sul

  • Hospital São Lucas da PUCRS

    Porto Alegre, Rio Grande do Sul

  • Instituto COI

    Rio de Janeiro

  • Instituto Nacional de Câncer - INCA

    Rio de Janeiro

  • Fm Abc/ Cepho

    Santo André, São Paulo

  • Faculdade de Medicina da Universidade de Sao Paulo

    São Paulo, São Paulo

Other trials in Brazil

Germany11 sites

  • Charité - Universitätsmedizin Berlin

    Berlin

  • Universitätsklinikum Bonn

    Bonn, North Rhine-Westphalia

  • Uniklinik Köln-Klinik für Gastroenterologie und Hepatologie am Abdominalzentrum

    Cologne, North Rhine-Westphalia

  • Universitätsklinik Carl-Gustav-Carus Dresden

    Dresden, Saxony

  • Kliniken Essen-Mitte Evang. Huyssens-Stiftung

    Essen

  • Universitätsklinikum Halle-Universitätsklinik und Poliklinik

    Halle

  • Facharztzentrum Eppendorf

    Hamburg

  • Universitätskllinikum Heidelberg

    Heidelberg

  • Universitätsklinikum Leipzig AöR

    Leipzig, Saxony

  • Klinikum der Universität München - Campus Grosshadern

    München, Bavaria

  • Universitätsklinikum Ulm

    Ulm, Baden-Wurttemberg

Other trials in Germany

Hungary11 sites

  • Egyesített Szent István és Szent László Kórház-Rendelőintéze

    Budapest

  • Magyar Honvédség Egészségügyi Központ

    Budapest

  • Országos Onkológiai Intézet

    Budapest

  • Semmelweis Egyetem - Isz. Bel, Onkológiai Részleg

    Budapest

  • Semmelweis Egyetem - Onkohaematológiai Osztály

    Budapest

  • Szent Margit Kórház

    Budapest

  • Debreceni Egyetem Klinikai Központ

    Debrecen, Hajdú-Bihar

  • Petz Aladár Megyei Oktató Kórház

    Győr, Győr-Moson-Sopron

  • Somogy Megyei Kaposi Mór Oktató Kórház

    Kaposvár

  • Pécsi Tudományegyetem Klinikai Központ

    Pécs, Baranya

  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpo

    Szeged, Csongrád megye

Other trials in Hungary

Israel11 sites

  • Ha'Emek Medical Center

    Afula

  • Assaf Harofeh Medical Center

    Be’er Ya‘aqov, Central District

  • Soroka Medical Center [Oncology]

    Beersheba

  • Hillel Yaffe Medical Center

    Hadera

  • Rambam Health Care Campus

    Haifa

  • Hadassah Medical Organisation

    Jerusalem, Jerusalem

  • Shaare Zedek Medical Center

    Jerusalem

  • Meir Medical Center

    Kfar Saba, Central District

  • Rabin Medical Center - Beilinson Hospital

    Petah Tikva, Central District

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, Tel Aviv

  • The Chaim Sheba Medical Center [Oncology]

    Tel HaShomer

Other trials in Israel

South Korea11 sites

  • Dong-A University Hospital

    Busan, Busan Gwang'yeogsi

  • Keimyung University Dongsan Medical Center

    Daegu, Daegu Gwang'yeogsi

  • Gachon University Gil Medical Center

    Incheon

  • Seoul National University Bundang Hospital

    Seongnam, Gyeonggido

  • Asan Medical Center

    Seoul, Seoul Teugbyeolsi

  • Korea University Anam Hospital

    Seoul, Seoul Teugbyeolsi

  • Samsung Medical Center

    Seoul, Seoul Teugbyeolsi

  • Severance Hospital, Yonsei University Health System

    Seoul, Seoul Teugbyeolsi

  • The Catholic University of Korea, Seoul St.Mary's Hospital

    Seoul, Seoul Teugbyeolsi

  • Korea University Guro Hospital

    Seoul

  • Seoul National University Hospital

    Seoul

Other trials in South Korea

Italy9 sites

  • PO di Cremona, ASST di Cremona

    Cremona

  • AO S. Martino, IRCCS, IST-Istituto Nazionale Ricerca Sul Cancro

    Genova

  • Ieo, Irccs

    Milan

  • IRCCS Ospedale S.Raffaele

    Milan

  • Istituto Oncologico Veneto IOV-IRCCS

    Padova

  • Regina Elena, Istituto Nazionale dei Tumori, IFO, IRCCS

    Roma

  • Istituto Clinico Humanitas Rozzano, IRCCS

    Rozzano, Milano

  • U.O. di Oncologia

    San Giovanni Rotondo, Foggia

  • Borgo Roma, Policlinico G.Rossi, AOU Integrata Verona

    Verona

Other trials in Italy

Australia8 sites

  • Bankstown-Lidcombe Hospital

    Bankstown, New South Wales

  • Flinders Medical Centre

    Bedford, South Australia

  • Bendigo Health Care Group

    Bendigo, Victoria

  • Monash Health

    Bentleigh East, Victoria

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales

  • St Vincent's Hospital

    Darlinghurst, New South Wales

  • Peninsula & South Eastern Haematology and Oncology Group

    Frankston, Victoria

  • Royal North Shore Hospital

    St Leonards, New South Wales

Other trials in Australia

Belgium7 sites

  • Imelda Ziekenhuis

    Bonheiden, Antwerpen

  • Cliniques Universitaires Saint-Luc

    Brussels, Brussels Capital, 1200

  • Hôpital Erasme

    Brussels, Brussels Capital

  • UZA

    Edegem, Antwerpen

  • AZ Maria Middelares - Campus Maria Middelares

    Ghent, Oost-Vlaanderen

  • UZ Leuven - Campus Gasthuisberg

    Leuven, Vlaams Brabant

  • Centre Hospitalier Universitaire (CHU) de Liege - Domaine Un

    Liège

Other trials in Belgium

Czechia5 sites

  • Masarykuv onkologicky ustav

    Brno, Brno-město

  • FN Hradec Kralove

    Hradec Králové, Hradec Králové Region

  • Fakultni nemocnice Olomouc

    Olomouc, Olomouc Region

  • Fakultni nemocnice v Motole

    Prague

  • Nemocnice Na Bulovce (Hospital Na Bulovce)

    Prague

Other trials in Czechia

Taiwan5 sites

  • Changhua Christian Hospital

    Changhua

  • China Medical University Hospital

    Taichung, Taichung Municipality

  • National Cheng Kung University Hospital

    Tainan

  • National Taiwan University Hospital

    Taipei

  • Veterans General Hospital- Taipei

    Taipei

Other trials in Taiwan

Netherlands4 sites

  • Academisch Medisch Centrum Universiteit van Amsterdam

    Amsterdam

  • Spaarne Gasthuis

    Hoofddorp

  • Maastricht University Medical Centre

    Maastricht, Limburg

  • Radboud Universiteit Nijmegen

    Nijmegen

Other trials in Netherlands

Latvia3 sites

  • Daugavpils Regional Hospital

    Daugavpils

  • P.Stradins Clinical University

    Riga

  • SIA "Rigas Austrumu Kliniska Universitates Slimnica"

    Riga

Other trials in Latvia

Poland3 sites

  • Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onko

    Brzozów, Podkarpackie Voivodeship

  • Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie

    Lublin

  • Centrum Onkologii Instytut im. M. Sklodowskiej-Curie

    Warsaw

Other trials in Poland

Canada2 sites

  • Royal Victoria Regional Health Centre

    Barrie, Ontario

  • Princess Margaret Hospital

    Toronto, Ontario

Other trials in Canada

Croatia2 sites

  • Klinicki bolnicki centar Zagreb

    Zagreb, City of Zagreb

  • Klinicki bolnički centar Sestre milosrdnice

    Zagreb

Other trials in Croatia

Estonia2 sites

  • East Tallinn Central Hospital Oncology Center

    Tallinn, Harju

  • North Estonian Medical Centre Foundation Clinic of Oncology

    Tallinn, Harju

Other trials in Estonia

Lithuania2 sites

  • National Cancer Institute

    Vilnius, Vilnius County

  • Vilniaus Universiteto ligonines Santariskiu Klinikos

    Vilnius, Vilnius County

Other trials in Lithuania

Denmark1 site

  • Odense Universitetshospital

    Odense, Region Syddanmark

Other trials in Denmark

About this study

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

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).

Read the detailed description

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

Being tested
Biological: PEGylated Recombinant Human Hyaluronidase (PEGPH20), Placebo, nab-Paclitaxel, Gemcitabine
Keywords
Pancreatic ductal adenocarcinoma (PDA), Pancreatic ductal carcinoma, PEGylated Recombinant Human Hyaluronidase (PEGPH20), Nab-paclitaxel, Gemcitabine, Metastatic, Stage IV
Medical subject headings
Carcinoma, Pancreatic Ductal, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biological: PEGylated Recombinant Human Hyaluronidase (PEGPH20)Other

    PEGPH20 will be administered as per the dose and schedule specified in the respective arms.

  • PlaceboDrug

    Matching placebo for PEGPH20

  • nab-PaclitaxelDrug

    Also called Abraxane®

    Nab-paclitaxel will be administered as per the dose and schedule specified in the respective arms.

  • GemcitabineDrug

    Also called Gemzar®

    Gemcitabine will be administered as per the dose and schedule specified in the respective arms.

Study groups in NCT02715804
Study groupRoleWhat they receive
PAG: PEGPH20 + nab-Paclitaxel + GemcitabineExperimentalParticipants 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.
Receives: Other: Biological: PEGylated Recombinant Human Hyaluronidase (PEGPH20); Drug: nab-Paclitaxel; Drug: Gemcitabine
AG: Placebo + nab-Paclitaxel + GemcitabinePlacebo comparatorParticipants will receive placebo matching to PEGPH20 as an IV infusion, twice weekly for Weeks 1 to 3 of Cycle 1 (each cycle consisting of 4 weeks [Week 4 of every cycle will be a rest week with no treatment]), then once weekly for Weeks 1 to 3 of Cycle 2 and beyond in combination with 125 mg/m^2 nab-paclitaxel as an IV infusion and 1000 mg/m^2 gemcitabine as an IV infusion, once weekly for Weeks 1 to 3 of all treatment cycles. Treatment will continue until disease progression, unacceptable toxicity, death, or withdrawal of consent.
Receives: Drug: Placebo; Drug: nab-Paclitaxel; Drug: Gemcitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

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

    Measured: From randomization until death from any cause (maximum exposure: 150.1 weeks for PAG, and 83.9 weeks for AG)

Secondary outcomes (7)

  1. 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.

    Measured: 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)

  2. 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.

    Measured: From the date of randomization until CR or PR (maximum exposure: 150.1 weeks for PAG, and 83.9 weeks for AG)

  3. 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.

    Measured: 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)

  4. 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'.

    Measured: 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)

  5. 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.

    Measured: 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)

  6. 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.

    Measured: 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)

  7. 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.

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2016 (estimated)
  2. Study start14 Mar 2016
  3. Primary completion4 Nov 2019
  4. Study completion4 Nov 2019

Why it stopped: Sponsor decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
492 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02715804
Sponsor's protocol ID
HALO-109-301
Other IDs
2015-004068-13, 2015
Status last verified
Jun 2020
First submitted
17 Mar 2016
Last updated
14 Jul 2020
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Biological: PEGylated Recombinant Human Hyaluronidase (PEGPH20), nab-Paclitaxel and Gemcitabine in people with Pancreatic Ductal Carcinoma, run by Halozyme Therapeutics at 217 sites in 22 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 217 sites in United States, France, Spain, United Kingdom, Brazil and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: From randomization until death from any cause (maximum exposure: 150.1 weeks for PAG, and 83.9 weeks for AG)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02715804.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2020.

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