AzTrials
AzTrials

Pancreatic NeoplasmsPhase 3apactNCT01964430

Nab-paclitaxel and Gemcitabine vs Gemcitabine Alone as Adjuvant Therapy for Patients With Resected Pancreatic Cancer (the "Apact" Study)

A Phase 3 study testing nab-Paclitaxel and Gemcitabine in people with Pancreatic Neoplasms and Digestive System Neoplasms, run by Celgene at 341 sites in 21 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to compare whether there is a delay or prevention of recurrence or death in participants with surgically removed pancreatic cancer who then take nab-Paclitaxel in combination with gemcitabine compared to those who take gemcitabine alone. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
nab-Paclitaxel and Gemcitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
866 participants
Where
341 sitesin 21 countries
Study dates
28 Mar 2014to 30 Jun 2022
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

  • Histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1). Subjects with neuroendocrine (and mixed type) tumors are excluded.
  • Pancreatic cancer surgical staging: Tumor (T) 1-3, Lymph Node (LN) N0-1, Metastasis (M) 0.
  • Subject should be able to start treatment no later than 12 weeks postsurgery.
  • ≥18 years of age at the time of signing the informed consent form (ICF).
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Acceptable hematology parameters:
Show all 16Show fewer
  • Absolute neutrophil count (ANC) ≥1500 cell/mm^3
  • Platelet count ≥100,000/mm^3
  • Hemoglobin (Hgb) ≥9 g/dL
  • Acceptable blood chemistry levels:
  • Aspartate aminotransferase (AST)/ serum glutamic oxaloacetic transaminase (SGOT) and alanine transaminase (ALT)/ serum glutamic -pyruvic transaminase (SGPT) ≤2.5 × upper limit of normal range (ULN)
  • Total bilirubin ≤ upper limit of normal (participants with Gilbert's syndrome can have bilirubin of up to 1.5 x ULN)
  • Alkaline phosphatase ≤ 2.5 x ULN
  • Serum creatinine within upper limits of normal or calculated clearance ≥50 mL/min/1.73 m^2. If using creatinine clearance, actual body weight should be used for calculating creatinine clearance (eg, using the Cockroft-Gault formula). For subjects with a body mass index (BMI) >30 kg/m2, lean body weight should be used instead
  • Cancer antigen (CA)19-9 <100 U/mL assessed within 14 days of randomization
  • Acceptable coagulation studies as demonstrated by prothrombin time (PT) and partial thromboplastin time (PTT) within normal limits (±15%)

Who cannot join

  • A subject will not be eligible for inclusion in this study if any of the following criteria apply:
  • Prior neo-adjuvant treatment or radiation therapy for pancreatic adenocarcinoma
  • Presence of or history of metastatic pancreatic adenocarcinoma
  • Any other malignancy within 5 years prior to randomization, with the exception of adequately treated in-situ carcinoma of the cervix, uteri, or nonmelanomatous skin cancer (all treatment of which should have been completed 6 months prior to randomization)
  • Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy, defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment
  • Known infection with hepatitis B or C, or history of human immunodeficiency virus (HIV) infection, or subject receiving immunosuppressive or myelosuppressive medications that would in the opinion of the investigator, increase the risk of serious neutropenic complications
Show all 11Show fewer
  • History of allergy or hypersensitivity to nab-paclitaxel or gemcitabine or any of their excipients
  • Serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders, which could compromise the subject's safety or the study data integrity. These include, but are not limited to:
  • History of connective tissue disorders (eg, lupus, scleroderma, arteritis nodosa)
  • History of interstitial lung disease, slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies
  • History of the following within 6 months prior to Cycle 1 Day 1: a myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) Class III-IV heart failure, uncontrolled hypertension, clinically significant cardiac dysrhythmia or electrocardiogram (ECG) abnormality, cerebrovascular accident, transient ischemic attack, or seizure disorder

Trial locations and contacts

341 sites in 21 countries.

341 sites in 21 countries

United States107 sites

  • Local Institution - 036

    Ann Arbor, Michigan, 48109

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Georgia Cancer Specialist

    Atlanta, Georgia, 30341

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045

  • Local Institution - 064

    Basking Ridge, New Jersey, 07920

  • MSKCC Basking Ridge

    Basking Ridge, New Jersey, 07920

  • Local Institution - 022

    Boca Raton, Florida, 33486

  • Lynn Cancer Institute

    Boca Raton, Florida, 33486

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Beth Israel-Deaconess Medical Center

    Boston, Massachusetts, 02115

  • Local Institution - 040

    Boston, Massachusetts, 02115

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Local Institution - 045

    Boston, Massachusetts, 02215

  • Local Institution - 025

    Buffalo, New York, 14263

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Local Institution - 038

    Charlottesville, Virginia, 22908

  • University of Virginia

    Charlottesville, Virginia, 22908

  • Chattanooga Oncology Hematology Care

    Chattanooga, Tennessee, 37404

  • Local Institution - 023

    Chattanooga, Tennessee, 37404

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • Local Institution - 030

    Cincinnati, Ohio, 45242

  • Oncology Hematology Care, Inc.

    Cincinnati, Ohio, 45242

  • University of Cincinnati Medical CenterDivsion of Hematology OncologyThe Barrett Center

    Cincinnati, Ohio, 45267-0501

  • Case Western Reserve Center

    Cleveland, Ohio, 44106

  • Local Institution - 047

    Cleveland, Ohio, 44106

  • Cleveland Clinic - Taussig Cancer Institute

    Cleveland, Ohio, 44195

  • Cleveland Clinic Foundation IRB

    Cleveland, Ohio, 44195

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Local Institution - 020

    Cleveland, Ohio, 44195

  • Local Institution - 054

    Cleveland, Ohio, 44195

  • Local Institution - 005

    Columbus, Ohio, 43210

  • Ohio State University Medical Center

    Columbus, Ohio, 43210

  • Memorial Sloan-Kettering Cancer Center

    Commack, New York, 11725

  • Texas Oncology

    Dallas, Texas, 75230

  • Baylor Sammons Cancer Center

    Dallas, Texas, 75246

  • Local Institution - 062

    Dallas, Texas, 75246

  • Local Institution - 010

    Dallas, Texas, 75390

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

  • Local Institution - 059

    Denver, Colorado, 80218

  • Rocky Mountain Cancer Centers, LLP [Denver-Midtown]

    Denver, Colorado, 80218

  • Karmanos Cancer Center Wayne State University

    Detroit, Michigan, 48201

  • Northshore University Healthsystem Research Institute

    Evanston, Illinois, 60201

  • Florida Cancer Institute Cancer Spec

    Fort Myers, Florida, 33916

  • Local Institution - 031

    Fort Myers, Florida, 33916

  • Local Institution - 050

    Fort Worth, Texas, 76104

  • The Center for Cancer and Blood Disorders - Fort Worth

    Fort Worth, Texas, 76104

  • Gainesville Heme Oncology Associates

    Gainesville, Florida, 32605

  • Local Institution - 011

    Gainesville, Florida, 32610

  • University of Florida

    Gainesville, Florida, 32610

  • Memorial Sloan Kettering Cancer Center West Harrison

    Harrison, New York, 10604

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Local Institution - 041

    Houston, Texas, 77030

  • UCSD Moores Cancer Center

    La Jolla, California, 92093

  • NYU Langone Medical Center

    Lake Success, New York, 11042

  • Saint Barnabas Medical Center

    Livingston, New Jersey, 07039

  • University of Southern California

    Los Angeles, California, 90033

  • University of Louisville

    Louisville, Kentucky, 40202

  • Local Institution - 014

    Madison, Wisconsin, 53792

  • University of Wisconsin - Madison Cancer Center

    Madison, Wisconsin, 53792

  • University of Miami and Sylvester Cancer Center

    Miami, Florida, 33136

  • Local Institution - 004

    Nashville, Tennessee, 37203

  • Sarah Cannon Research Inst

    Nashville, Tennessee, 37203

  • Local Institution - 002

    Nashville, Tennessee, 37232-6307

  • Vanderbilt- Ingram Cancer Center

    Nashville, Tennessee, 37232-6307

  • Yale Cancer Center

    New Haven, Connecticut, 06510

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121-2483

  • Ochsner Medical Center - Jefferson Highway

    New Orleans, Louisiana, 70121-2483

  • Local Institution - 008

    New York, New York, 10021-6007

  • Memorial Sloan-Kettering Cancer Center - NYC

    New York, New York, 10021-6007

  • Columbia University Medical Center

    New York, New York, 10032

  • Local Institution - 032

    New York, New York, 10032

  • Illinois Cancer Specialists

    Niles, Illinois, 60714

  • Local Institution - 049

    Oklahoma City, Oklahoma, 73104

  • University of Oklahoma Peggy and Charles Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104

  • Local Institution - 048

    Omaha, Nebraska, 68114

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

  • Florida Hospital Cancer Institute

    Orlando, Florida, 32804

  • Local Institution - 039

    Orlando, Florida, 32804

  • Local Institution - 016

    Philadelphia, Pennsylvania, 19107

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Local Institution - 027

    Pittsburgh, Pennsylvania, 15232

  • UPMC Cancer Pavillion

    Pittsburgh, Pennsylvania, 15232

  • Local Institution - 019

    Portland, Oregon, 97239

  • Oregon Health and Science University OHSU

    Portland, Oregon, 97239

  • Local Institution - 021

    Rochester, Minnesota, 55905

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Local Institution - 013

    Rochester, New York, 14642

  • University of Rochester Cancer Center, James P. Wilmot Cancer Center

    Rochester, New York, 14642

  • Local Institution - 066

    Rockville Centre, New York, 11570

  • MSKCC at Mercy Medical Center Mercy RockvilleCenter

    Rockville Centre, New York, 11570

  • Local Institution - 044

    Sacramento, California, 95817

  • UC Davis Cancer Center

    Sacramento, California, 95817

  • Local Institution - 001

    San Francisco, California, 94110

  • University of California, San Francisco Cutaneous Oncology and Melanoma Center

    San Francisco, California, 9411

  • University of California Los Angeles

    Santa Monica, California, 90404

  • Local Institution - 043

    Scottsdale, Arizona, 85259

  • Mayo Clinic - Arizona

    Scottsdale, Arizona, 85259

  • Local Institution - 003

    Seattle, Washington, 98109

  • Seattle Cancer Care Alliance - Seattle

    Seattle, Washington, 98109

  • Virginia Mason Cancer Center

    Seattle, Washington, 98111

  • MSKCC at Phelps Memorial Hospital Center. Phelps Sleepy Hollow

    Sleepy Hollow, New York, 10591

  • State University of New York Upstate Medical Center

    Syracuse, New York, 13215

  • H Lee Moffitt Cancer Center

    Tampa, Florida, 32207

  • Texas Oncology, P.A. - Tyler

    Tyler, Texas, 75702

  • Local Institution - 051

    Winston-Salem, North Carolina, 27157-1082

  • Wake Forest Univ. Health Sciences Outpatient Comprehensive Cancer Center

    Winston-Salem, North Carolina, 27157-1082

Other trials in United States

Germany31 sites

  • Klinikum Weiden

    Bayern, 92637

  • Local Institution - 280

    Bayern, 92637

  • Charite - Universitätsmedizin Berlin

    Berlin, 12203

  • Local Institution - 272

    Berlin, 12203

  • Local Institution - 281

    Cologne, 50674

  • Praxis Internistischer Onkologie und Hamatologie Koln

    Cologne, 50674

  • Local Institution - 278

    Dresden, D-01307

  • Universitatsklinikum Carl Gustav Carus an der TU Dresden

    Dresden, D-01307

  • Kliniken Essen-Mitte

    Essen, 45136

  • Local Institution - 277

    Frankfurt, 60590

  • Universitatsklinkum Frankfurt

    Frankfurt, 60590

  • Local Institution - 284

    Frechen, 50226

  • Praxis Internistischer Onkologie und Hamatologie Frechen

    Frechen, 50226

  • Local Institution - 275

    Friedrichshafen, 88045

  • Praxis für Innere Medizin, Dr.Oettle Helmut

    Friedrichshafen, 88045

  • Ernst-Moritz-Arndt-Universität Greifswald

    Greifswald, 17487

  • Local Institution - 279

    Greifswald, 17487

  • Local Institution - 273

    Hamburg, 20246

  • Universitaetsklinik Hamburg - Eppendorf

    Hamburg, 20246

  • Local Institution - 274

    Magdeburg, 39108

  • Universitatsklinik Magdeburg

    Magdeburg, 39108

  • Klinikum der Johannes Gutenberg Uniervsitaet ,Haematologie

    Mainz, 55131

  • Local Institution - 283

    Mainz, 55131

  • Klinikum der Universitat Munchen-Grosshadern

    München, 81377

  • Local Institution - 282

    München, 81377

  • Klinikum Neuperlach

    München, 81737

  • Local Institution - 276

    München, 81737

  • Local Institution - 0271

    Tübingen, 72076

  • University of Tubingen

    Tübingen, 72076

  • Local Institution - 270

    Würzburg, 97080

  • Universitatsklinikum Würzburg

    Würzburg, 97080

Other trials in Germany

Italy28 sites

  • Local Institution - 325

    Ancona, 60020

  • Ospedali Riuniti Umberto I GM Lancisi

    Ancona, 60020

  • Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi

    Bologna, 40138

  • Local Institution - 330

    Bologna, 40138

  • Azienda Ospedaliero-Universitaria Careggi

    Florence, 50134

  • Local Institution - 328

    Florence, 50134

  • Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori (I.R.S.T.)

    Meldola, 47014

  • Local Institution - 331

    Meldola, 47014

  • Local Institution - 321

    Milan, 20132

  • Ospedale San Raffaele S.r.l.

    Milan, 20132

  • Azienda Ospedaliera Niguarda Ca Granda

    Milan, 20162

  • Local Institution - 322

    Milan, 20162

  • Azienda Ospedaliero-Universitaria Pisana

    Pisa, 56126

  • Local Institution - 324

    Pisa, 56126

  • Arcispedale Santa Maria Nuova

    Reggio Emilia, 42100

  • Local Institution - 333

    Reggio Emilia, 42100

  • Local Institution - 323

    Roma, 00144

  • Local Institution - 327

    Roma, 00168

  • Policlinico Universitario Agostino Gemelli

    Roma, 00168

  • Istituto Nazionale Tumori Regina Elena

    Roma, 144

  • Istituto Clinico Humanitas

    Rozzano (MI), 20089

  • Local Institution - 326

    Rozzano (MI), 20089

  • IRCCS Casa Sollievo della Sofferenza

    San Giovanni Rotondo, 71013

  • Local Institution - 332

    San Giovanni Rotondo, 71013

  • Local Institution - 329

    Terni, Umbria, 05100

  • Azienda Ospedaliera S Maria di Terni

    Terni, 05100

  • Azienda Ospedaliera Universitaria Integrata di Verona

    Verona, 37134

  • Local Institution - 320

    Verona, 37134

Other trials in Italy

Spain26 sites

  • Local Institution - 360

    Barcelona, 08035

  • Clinic Barcelona Hospital Universitari

    Barcelona, 08036

  • Local Institution - 363

    Barcelona, 08036

  • Instituto Catalan de Oncologia-Hospital Duran

    Barcelona, 08907

  • Local Institution - 370

    Barcelona, 08907

  • Hospital Universitari Vall d'Hebron

    Barcelona, 8035

  • Hospital General Gregorio Maranon

    Madrid, 28007

  • Local Institution - 367

    Madrid, 28007

  • Local Institution - 362

    Madrid, 28034

  • Ramon y Cajal Univeresity Hospital

    Madrid, 28034

  • Hospital Clinico San Carlos

    Madrid, 28040

  • Local Institution - 372

    Madrid, 28040

  • Hospital 12 de Octubre

    Madrid, 28041

  • Local Institution - 365

    Madrid, 28041

  • Centro Integral

    Madrid, 28050

  • Local Institution - 361

    Madrid, 28050

  • Hospital General Carlos Haya

    Málaga, 29010

  • Local Institution - 369

    Málaga, 29010

  • Complejo Hospitalario de Navarra

    Pamplona/ Navarra, 31008

  • Local Institution - 368

    Pamplona/ Navarra, 31008

  • Local Institution - 371

    Santander, Cantabria, 39008

  • Hospital Universitario Marques de Valdecilla

    Santander, 39008

  • Hospital Clinico Universitario De Santiago De Compostela

    Santiago de Compostela, 15706

  • Local Institution - 366

    Santiago de Compostela, 15706

  • Hospital Virgen del Rocio

    Seville, 41013

  • Local Institution - 364

    Seville, 41013

Other trials in Spain

Australia21 sites

  • Local Institution - 506

    Bentleigh East, Victoria, 3165

  • Monash Medical Centre Moorabbin Campus

    Bentleigh East, 3165

  • Local Institution - 501

    Darlinghurst, New South Wales, 2010

  • Saint Vincent's Hospital

    Darlinghurst, 2010

  • Canberra Hospital

    Garran, Australian Capital Territory, 2605

  • Local Institution - 505

    Garran, Australian Capital Territory, 2605

  • Austin Hospital

    Heidelberg, 3084

  • Local Institution - 509

    Heidelberg, 3084

  • Local Institution - 504

    Herston, Queensland, 4029

  • Royal Brisbane and Women's Hospital

    Herston, 4029

  • Cabrini Hospital

    Malvern, 3144

  • Local Institution - 503

    Malvern, 3144

  • ICON Cancer Center

    Milton, Queensland, 4064

  • Local Institution - 502

    Milton, Queensland, 4064

  • Local Institution - 500

    Randwick, 2031

  • Prince of Wales Hospital

    Randwick, 2031

  • Local Institution - 507

    St Leonards, New South Wales, 2065

  • Northern Cancer Institute

    St Leonards, New South Wales, 2065

  • Local Institution - 508

    Subiaco, Western Australia, 6008

  • St John of God Subiaco Hospital

    Subiaco, Western Australia, 6008

  • The Queen Elizabeth Hospital

    Woodville South, 5011

Other trials in Australia

France18 sites

  • Center Hospitalier Universitaire d' Angers

    Angers, 49033

  • Local Institution - 253

    Angers, 49033

  • Hopital Henri Mondor

    Créteil, 94010

  • CHRU de Lille France

    Lille, 59037

  • Local Institution - 257

    Lille, 59037

  • Hopital prive Jean Mermoz

    Lyon, 69008

  • Local Institution - 252

    Lyon, 69008

  • Hopital Edouard Herriot - Hepato-gastroenterologie

    Lyon, 69437

  • Local Institution - 258

    Lyon, 69437

  • Hopital Europeen Georges Pompidou

    Paris, 75015

  • Local Institution - 250

    Paris, 75015

  • Hopital Saint Antoine

    Paris, 75571

  • Hopital Pitie Salpetriere

    Paris, 75651

  • Local Institution - 259

    Paris, 75651

  • CHU La Miletrie

    Poitiers, 86021

  • Local Institution - 251

    Poitiers, 86021

  • Local Institution - 256

    Toulose, 31059

  • Pole Des Specialites Medicales, Hopital Purpan

    Toulose, 31059

Other trials in France

Austria16 sites

  • Local Institution - 205

    Graz, 8036

  • Medical University of Graz

    Graz, A-8036

  • Local Institution - 203

    Innsbruck, 6020

  • Medical University Innsbruck

    Innsbruck, 6020

  • Hospital of Elisabethinen Linz

    Linz, 4010

  • Local Institution - 206

    Linz, 4010

  • Local Institution - 204

    Salzburg, 5020

  • Salzburger Landkliniken St. Johanns-Spital

    Salzburg, 5020

  • Local Institution - 200

    Vienna, 1090

  • Medizinische Universitat Wien

    Vienna, 1090

  • Kaiser-Franz-Josef Spital

    Vienna, 1100

  • Local Institution - 201

    Vienna, 1100

  • Klinikum Wels-Grieskirchen GmbH

    Wels, 4600

  • Local Institution - 0207

    Wels, 4600

  • Hospital Wiener Neustadt

    Wiener Neustadt, 2700

  • Local Institution - 202

    Wiener Neustadt, 2700

Other trials in Austria

Taiwan12 sites

  • Local Institution - 620

    Taichung, 40705

  • Taichung Veterans General Hospital

    Taichung, 40705

  • Local Institution - 625

    Tainan, Taiana, 704

  • National Cheng Kung University Hospital

    Tainan, Taiana, 704

  • Local Institution - 623

    Taipei, 11217

  • Taipei Veterans General Hospital

    Taipei, 11217

  • Tri-Service General Hospital

    Taipei, 11490

  • Local Institution - 622

    Taipei, 114

  • Chang Gung Medical Foundation-Linkou Branch

    Taoyuan, 333

  • Local Institution - 624

    Taoyuan, 333

  • Local Institution - 621

    Tapei, 10002

  • National Taiwan University Hospital

    Tapei, 10002

Other trials in Taiwan

Hungary11 sites

  • Fovarosi Szent Istvan es Szent Laszlo Korhaz es Rendelointezet

    Budapest, 1097

  • Local Institution - 293

    Budapest, 1097

  • Local Institution - 291

    Budapest, 1145

  • Uzsoki Utcai Korhaz

    Budapest, 1145

  • Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum

    Debrecen, 4032

  • Local Institution - 290

    Debrecen, 4032

  • Local Institution - 292

    Győr, 9024

  • Petz Aladar Megyei Oktato Korhaz,II. Belgyogyaszat

    Győr, 9024

  • Local Institution - 295

    Szeged, 6720

  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Szent-Gyorgyi Albert TE AOK Borgyogy

    Szeged, 6720

  • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet

    Szolnok, 5004

Other trials in Hungary

Canada10 sites

  • Local Institution - 102

    Calgary, Alberta, T2N 4N2

  • Tom Baker Cancer Center

    Calgary, Alberta, T2N 4N2

  • Centre Hospitalier de L'Universite de Montreal St-Luc

    Montreal, Quebec, H2X 3J4

  • Local Institution - 104

    Montreal, Quebec, H2X 3J4

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • Local Institution - 103

    Montreal, Quebec, H3T 1E2

  • Local Institution - 101

    Toronto, Ontario, M4N 3M5

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • Local Institution - 100

    Toronto, Ontario, M5G 2M9

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Belgium7 sites

  • Hopital Erasme

    Brussels, 1070

  • Local Institution - 211

    Brussels, 1070

  • UZ Antwerpen

    Edegem, 2650

  • Local Institution - 213

    Ghent, 9000

  • UZ Gent

    Ghent, 9000

  • Local Institution - 210

    Leuven, 3000

  • UZ Leuven

    Leuven, 3000

Other trials in Belgium

Denmark6 sites

  • Hæmatologisk afd. B Aalborg Sygehus Syd

    Aalborg, 9000

  • Local Institution - 231

    Aalborg, 9000

  • Herlev Hospital

    Herlev, 2730

  • Local Institution - 232

    Herlev, 2730

  • Local Institution - 230

    Odense C, 5000

  • Onk.Dep., Odense Universitets hospital

    Odense C, 5000

Other trials in Denmark

Finland6 sites

  • Helsingin yliopistollinen keskussairaala

    Helsinki, FI-00290

  • Local Institution - 241

    Helsinki, FI-00290

  • Local Institution - 240

    Tampere, Oulun Lääni, FI-33520

  • Tampereen yliopistollinen sairaala

    Tampere, 33521

  • Local Institution - 242

    Turku, 20521

  • Turku University Hospital

    Turku, 20521

Other trials in Finland

Netherlands6 sites

  • Academisch Medisch Centrum Amsterdam

    Amsterdam, 1105

  • Local Institution - 400

    Amsterdam, 1105

  • Catharina Hospital

    Eindhoven, 5632 EJ

  • Local Institution - 403

    Eindhoven, 5632 EJ

  • Isala Klinieken

    Zwolle, 8011

  • Local Institution - 402

    Zwolle, 8011

Other trials in Netherlands

Portugal6 sites

  • Centro Hospitalar de Lisboa Central - Hospital de Santo António dos Capuchos

    Lisbon, 1069-639

  • Local Institution - 340

    Lisbon, 1069-639

  • Hospital Da Luz

    Lisbon, 1500-650

  • Local Institution - 341

    Lisbon, 1500-650

  • Hospital de Sao Joao

    Porto, 4200

  • Local Institution - 342

    Porto, 4200

Other trials in Portugal

South Korea6 sites

  • Local Institution - 641

    Seoul, 03080

  • Seoul National University Hospital

    Seoul, 03080

  • Local Institution - 642

    Seoul, 135-710

  • Samsung Medical Center

    Seoul, 135-710

  • Asan Medical Center

    Seoul, 138-736

  • Local Institution - 640

    Seoul, 138-736

Other trials in South Korea

United Kingdom6 sites

  • Addenbrookes Hospital

    Cambridge, CB2 0QQ

  • Local Institution - 382

    Cambridge, CB2 0QQ

  • Glasgow Royal Infirmary

    Glasgow, G11 6NT

  • Local Institution - 380

    Glasgow, G11 6NT

  • Local Institution - 381

    Sheffield, S10 2SJ

  • Weston Park Hospital

    Sheffield South Yorkshire, S10 2SS

Other trials in United Kingdom

Czechia5 sites

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05

  • Local Institution - 220

    Hradec Králové, 500 05

  • Krajska nemocnice Liberec, a.s.

    Liberec, 460 63

  • Krajska nemocnice T. Bati a.s.

    Zlín, 762 75

  • Local Institution - 221

    Zlín, 762 75

Other trials in Czechia

Hong Kong5 sites

  • Local Institution - 601

    Hong Kong, 0

  • Queen Mary Hospital

    Hong Kong

  • Tuen Mun Hospital

    Hong Kong

  • Local Institution - 602

    Shatin, 0

  • Prince of Wales Hospital the Chinese University of Hong Kong

    Shatin

Other trials in Hong Kong

Ireland4 sites

  • Local Institution - 311

    Cork, T12 DFK4

  • Cork University Hospital

    Cork

  • Local Institution - 310

    Dublin, 4

  • St Vincent's University Hospital

    Dublin, 4

Other trials in Ireland

Singapore4 sites

  • Local Institution - 610

    Singapore, 119074

  • National University Hospital

    Singapore, 119074

  • Local Institution - 611

    Singapore, 169-610

  • National Cancer Center

    Singapore, 169-610

Other trials in Singapore

About this study

Official title: A Phase 3, Multicenter, Open-label, Randomized Study of Nab-Paclitaxel Plus Gemcitabine Versus Gemcitabine Alone as Adjuvant Therapy in Subjects With Surgically Resected Pancreatic Adenocarcinoma

The purpose of this study is to compare whether there is a delay or prevention of recurrence or death in participants with surgically removed pancreatic cancer who then take nab-Paclitaxel in combination with gemcitabine compared to those who take gemcitabine alone.

Read the detailed description

ABI-007-PANC-003 is a Phase 3, international, multicenter, randomized, open-label, controlled study that will compare the efficacy of nab-paclitaxel in combination with gemcitabine to gemcitabine alone as adjuvant treatment for 6 cycles in patients with surgically resected pancreatic adenocarcinoma.

Keywords
Resectable pancreatic cancer, resected, resectable PDA, adenocarcinoma, surgically resected, adjuvant, Abraxane, nab-paclitaxel, ABI-007, gemcitabine, Gemzar, Phase 3
Medical subject headings
Pancreatic Neoplasms, Digestive System Neoplasms, Neoplasms by Site, Neoplasms, Endocrine Gland Neoplasms, Pancreatic Diseases, Digestive System Diseases, Endocrine System Diseases

What participants receive

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

  • nab-PaclitaxelDrug

    Also called Abraxane

    nab-Paclitaxel 125 mg/m^2 on Days 1, 8, and 15 of every 28 day treatment cycle by intravenous (IV) administration for a total of 6 cycles.

  • GemcitabineDrug

    Also called Gemzar

    Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15 of a 28 day cycle by IV administration for a total of 6 cycles.

Study groups in NCT01964430
Study groupRoleWhat they receive
nab-Paclitaxel 125 mg/m^2 plus gemcitabine 1000 mg/m2ExperimentalParticipants received nab-Paclitaxel 125 mg/m^2 administered as an intravenous (IV) infusion over 30 to 40 minutes, followed by gemcitabine 1000 mg/m^2 as an IV infusion over 30 to 40 minutes on Days 1, 8 and 15 of each 28-day treatment cycle for 6 cycles, unless there was evidence of radiologic disease recurrence, unacceptable toxicity, subject or physician decision, withdrawal of consent, or death.
Receives: Drug: nab-Paclitaxel; Drug: Gemcitabine
Gemcitabine 1000 mg/m^2Active comparatorParticipants received gemcitabine 1000 mg/m^2 administered as an IV infusion over 30 to 40 minutes on Days 1, 8 and 15 of each 28-day treatment cycle for 6 cycles, unless there was evidence of radiologic disease recurrence, unacceptable toxicity, subject or physician decision, withdrawal of consent, or death.
Receives: Drug: Gemcitabine

What is being measured

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

  1. Kaplan Meier Estimate for Disease Free Survival (DFS) According to the Independent Radiological Review Committee

    Disease free survival was defined as the time from the date of randomization to the date of disease recurrence or death, whichever occurred earlier. Disease recurrence was determined by the independent radiological review of computed tomography (CT) or magnetic resonance imaging (MRI) scans. Participants who did not have disease recurrence or did not die were censored at the last tumor assessment date with disease-free status or the randomization date if the last tumor assessment with disease-free status was missing. Disease-free status referred to a status that was neither being disease recurrent nor indeterminate or not evaluable. Participants who received new anti-cancer therapy or cancer-related surgery prior to disease recurrence or death were censored at the date of last tumor assessment with disease-free status prior to the start of new anti-cancer therapy or cancer-related surgery or the randomization date.

    Measured: Date of randomization up to data cut off date of 31 December 2018; median DFS follow-up time for censored participants was 22.242 months for nab-Paclitaxel and gemcitabine and 13.832 months for gemcitabine alone

Secondary outcomes (3)

  1. Kaplan Meier Estimate of Overall Survival (OS)

    Overall survival was defined as the time from the date of randomization to the date of death. Participants who were alive at the end of study or clinical data cut were censored on the last-known-to-be-alive date or the clinical cutoff date, whichever was earlier.

    Measured: From randomization to date of death; median OS follow-up time for censored participants was 77.832 months for nab-Paclitaxel and gemcitabine and 77.799 months for gemcitabine alone

  2. Number of Participants With Treatment Emergent Adverse Events (TEAE's)

    TEAEs are defined as any adverse event (AE) that begin or worsen on or after the start of study drug or procedure of the study period through the maximum duration of the period plus 28 days. The severity of AEs was graded based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 and the scale: Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death. Relation to study drug was determined by the investigator. A treatment-related TEAE is defined as TEAE which was considered to be related to one or both of the study drugs and reported as 'Suspected' on the case report form. AEs with a missing relationship were treated as 'treatment-related' in data summaries. IP (investigational product) refers to nab-Paclitaxel and/or Gemcitabine. "Related" TEAE refers to relation to study drug (IP).

    Measured: From day 1 of study drug up to 28 days after the last dose of study drug; up to the data cut off date of 31 December 2018 (up to approximately 37 weeks).

  3. The Number of Participants With Clinical Chemistry Laboratory-Detected Abnormalities (Grade 3-4)

    The number of participants with grade 3-4 laboratory abnormalities in selected clinically significant parameters. Grades for chemistry parameters were coded using National Cancer Institute Common Terminology Criteria for Adverse Events (Grade 3= severe, Grade 4= life-threatening).

    Measured: From day 1 of study drug up to 28 days after the last dose of study drug, or the treatment discontinuation date, whichever was later (up to approximately 37 weeks).

Timeline

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

  1. First posted17 Oct 2013 (estimated)
  2. Study start28 Mar 2014
  3. Primary completion30 Jun 2022
  4. Study completion30 Jun 2022

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
None (open label)
Enrolment
866 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01964430
Sponsor's protocol ID
ABI-007-PANC-003
Other IDs
2013-003398-91
Acronym
apact
Status last verified
Jun 2023
First submitted
14 Oct 2013
Last updated
28 Jun 2023
Data monitoring committee
Yes

Publications

  • Young R, Mainwaring P, Clingan P, Parnis FX, Asghari G, Beale P, Aly A, Botteman M, Romano A, Ferrara S, Margunato-Debay S, Harris M. nab-Paclitaxel plus gemcitabine in metastatic pancreatic adenocarcinoma: Australian subset analyses of the phase III MPACT trial. Asia Pac J Clin Oncol. 2018 Oct;14(5):e325-e331. doi: 10.1111/ajco.12999. Epub 2018 Jun 22.

    PubMed 29932294

  • Reni M, Zanon S, Balzano G, Passoni P, Pircher C, Chiaravalli M, Fugazza C, Ceraulo D, Nicoletti R, Arcidiacono PG, Macchini M, Peretti U, Castoldi R, Doglioni C, Falconi M, Partelli S, Gianni L. A randomised phase 2 trial of nab-paclitaxel plus gemcitabine with or without capecitabine and cisplatin in locally advanced or borderline resectable pancreatic adenocarcinoma. Eur J Cancer. 2018 Oct;102:95-102. doi: 10.1016/j.ejca.2018.07.007. Epub 2018 Aug 24.

    PubMed 30149366

  • Fernandez A, Salgado M, Garcia A, Buxo E, Vera R, Adeva J, Jimenez-Fonseca P, Quintero G, Llorca C, Canabate M, Lopez LJ, Munoz A, Ramirez P, Gonzalez P, Lopez C, Reboredo M, Gallardo E, Sanchez-Canovas M, Gallego J, Guillen C, Ruiz-Miravet N, Navarro-Perez V, De la Camara J, Ales-Diaz I, Pazo-Cid RA, Carmona-Bayonas A. Prognostic factors for survival with nab-paclitaxel plus gemcitabine in metastatic pancreatic cancer in real-life practice: the ANICE-PaC study. BMC Cancer. 2018 Nov 29;18(1):1185. doi: 10.1186/s12885-018-5101-3.

    PubMed 30497432

  • Sonbol MB, Ahn DH, Goldstein D, Okusaka T, Tabernero J, Macarulla T, Reni M, Li CP, O'Neil B, Van Cutsem E, Bekaii-Saab T. CanStem111P trial: a Phase III study of napabucasin plus nab-paclitaxel with gemcitabine. Future Oncol. 2019 Apr;15(12):1295-1302. doi: 10.2217/fon-2018-0903. Epub 2019 Feb 15.

    PubMed 30768369

  • Tempero MA, Pelzer U, O'Reilly EM, Winter J, Oh DY, Li CP, Tortora G, Chang HM, Lopez CD, Bekaii-Saab T, Ko AH, Santoro A, Park JO, Noel MS, Frassineti GL, Shan YS, Dean A, Riess H, Van Cutsem E, Berlin J, Philip P, Moore M, Goldstein D, Tabernero J, Li M, Ferrara S, Le Bruchec Y, Zhang G, Lu B, Biankin AV, Reni M; APACT Investigators. Adjuvant nab-Paclitaxel + Gemcitabine in Resected Pancreatic Ductal Adenocarcinoma: Results From a Randomized, Open-Label, Phase III Trial. J Clin Oncol. 2023 Apr 10;41(11):2007-2019. doi: 10.1200/JCO.22.01134. Epub 2022 Dec 15.

    PubMed 36521097

  • Reni M, Braverman J, Hendifar A, Li CP, Macarulla T, Oh DY, Riess H, Tempero M, Lu B, Marcus J, Joshi N, Botteman M, Dueck AC. Evaluation of Minimal Important Difference and Responder Definition in the EORTC QLQ-PAN26 Module for Assessing Health-Related Quality of Life in Patients with Surgically Resected Pancreatic Adenocarcinoma. Ann Surg Oncol. 2021 Nov;28(12):7545-7554. doi: 10.1245/s10434-021-09816-z. Epub 2021 Apr 3.

    PubMed 33813673

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing nab-Paclitaxel and Gemcitabine in people with Pancreatic Neoplasms and Digestive System Neoplasms, run by Celgene at 341 sites in 21 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 16 inclusion and 11 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: finished, as of the sponsor's last update on 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 341 sites in United States, Germany, Italy, Spain, Australia and 16 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. 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 6 Jan 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?

Kaplan Meier Estimate for Disease Free Survival (DFS) According to the Independent Radiological Review Committee (time frame: Date of randomization up to data cut off date of 31 December 2018; median DFS follow-up time for censored participants was 22.242 months for nab-Paclitaxel and gemcitabine and 13.832 months for gemcitabine alone). 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 NCT01964430, which also lists 6 linked publications.

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 28 Jun 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in