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

June 13, 2023 updated by: Celgene

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

866

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Bentleigh East, Australia, 3165
        • Monash Medical Centre Moorabbin Campus
      • Darlinghurst, Australia, 2010
        • Saint Vincent's Hospital
      • Heidelberg, Australia, 3084
        • Austin Hospital
      • Heidelberg, Australia, 3084
        • Local Institution - 509
      • Herston, Australia, 4029
        • Royal Brisbane and Women's Hospital
      • Malvern, Australia, 3144
        • Cabrini Hospital
      • Malvern, Australia, 3144
        • Local Institution - 503
      • Randwick, Australia, 2031
        • Prince of Wales Hospital
      • Randwick, Australia, 2031
        • Local Institution - 500
      • Woodville South, Australia, 5011
        • The Queen Elizabeth Hospital
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia, 2605
        • Canberra Hospital
      • Garran, Australian Capital Territory, Australia, 2605
        • Local Institution - 505
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • Local Institution - 501
      • St Leonards, New South Wales, Australia, 2065
        • Northern Cancer Institute
      • St Leonards, New South Wales, Australia, 2065
        • Local Institution - 507
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Local Institution - 504
      • Milton, Queensland, Australia, 4064
        • Icon Cancer Center
      • Milton, Queensland, Australia, 4064
        • Local Institution - 502
    • Victoria
      • Bentleigh East, Victoria, Australia, 3165
        • Local Institution - 506
    • Western Australia
      • Subiaco, Western Australia, Australia, 6008
        • St John of God Subiaco Hospital
      • Subiaco, Western Australia, Australia, 6008
        • Local Institution - 508
  • Austria
      • Graz, Austria, A-8036
        • Medical University of Graz
      • Graz, Austria, 8036
        • Local Institution - 205
      • Innsbruck, Austria, 6020
        • Medical University Innsbruck
      • Innsbruck, Austria, 6020
        • Local Institution - 203
      • Linz, Austria, 4010
        • Hospital of Elisabethinen Linz
      • Linz, Austria, 4010
        • Local Institution - 206
      • Salzburg, Austria, 5020
        • Local Institution - 204
      • Salzburg, Austria, 5020
        • Salzburger Landkliniken St. Johanns-Spital
      • Wels, Austria, 4600
        • Klinikum Wels-Grieskirchen GmbH
      • Wels, Austria, 4600
        • Local Institution - 0207
      • Wien, Austria, 1090
        • Medizinische Universität Wien
      • Wien, Austria, 1090
        • Local Institution - 200
      • Wien, Austria, 1100
        • Kaiser-Franz-Josef Spital
      • Wien, Austria, 1100
        • Local Institution - 201
      • Wiener Neustadt, Austria, 2700
        • Hospital Wiener Neustadt
      • Wiener Neustadt, Austria, 2700
        • Local Institution - 202
  • Belgium
      • Brussels, Belgium, 1070
        • Hopital Erasme
      • Brussels, Belgium, 1070
        • Local Institution - 211
      • Edegem, Belgium, 2650
        • UZ Antwerpen
      • Gent, Belgium, 9000
        • UZ Gent
      • Gent, Belgium, 9000
        • Local Institution - 213
      • Leuven, Belgium, 3000
        • UZ Leuven
      • Leuven, Belgium, 3000
        • Local Institution - 210
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Tom Baker Cancer Center
      • Calgary, Alberta, Canada, T2N 4N2
        • Local Institution - 102
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Hospital
      • Toronto, Ontario, Canada, M4N 3M5
        • Local Institution - 101
      • Toronto, Ontario, Canada, M5G 2M9
        • Local Institution - 100
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Jewish General Hospital
      • Montreal, Quebec, Canada, H2X 3J4
        • Centre Hospitalier de L'Universite de Montreal St-Luc
      • Montreal, Quebec, Canada, H2X 3J4
        • Local Institution - 104
      • Montreal, Quebec, Canada, H3T 1E2
        • Local Institution - 103
  • Czechia
      • Hradec Kralove, Czechia, 500 05
        • Fakultni nemocnice Hradec Kralove
      • Hradec Kralove, Czechia, 500 05
        • Local Institution - 220
      • Liberec, Czechia, 460 63
        • Krajska nemocnice Liberec, a.s.
      • Zlin, Czechia, 762 75
        • Krajska nemocnice T. Bati a.s.
      • Zlin, Czechia, 762 75
        • Local Institution - 221
  • Denmark
      • Aalborg, Denmark, 9000
        • Hæmatologisk afd. B Aalborg Sygehus Syd
      • Aalborg, Denmark, 9000
        • Local Institution - 231
      • Herlev, Denmark, 2730
        • Herlev Hospital
      • Herlev, Denmark, 2730
        • Local Institution - 232
      • Odense C, Denmark, 5000
        • Local Institution - 230
      • Odense C, Denmark, 5000
        • Onk.Dep., Odense Universitets hospital
  • Finland
      • Helsinki, Finland, FI-00290
        • Helsingin Yliopistollinen Keskussairaala
      • Helsinki, Finland, FI-00290
        • Local Institution - 241
      • Tampere, Finland, 33521
        • Tampereen yliopistollinen sairaala
      • Turku, Finland, 20521
        • Turku University Hospital
      • Turku, Finland, 20521
        • Local Institution - 242
    • Oulun Lääni
      • Tampere, Oulun Lääni, Finland, FI-33520
        • Local Institution - 240
  • France
      • Angers cedex 09, France, 49033
        • Center Hospitalier Universitaire d' Angers
      • Angers cedex 09, France, 49033
        • Local Institution - 253
      • Creteil, France, 94010
        • Hôpital Henri Mondor
      • Lille, France, 59037
        • CHRU de Lille France
      • Lille, France, 59037
        • Local Institution - 257
      • Lyon, France, 69008
        • Hopital Prive Jean Mermoz
      • Lyon, France, 69008
        • Local Institution - 252
      • Lyon Cedex 3, France, 69437
        • Hopital Edouard Herriot - Hepato-gastroenterologie
      • Lyon Cedex 3, France, 69437
        • Local Institution - 258
      • Paris, France, 75015
        • Hopital Europeen Georges Pompidou
      • Paris, France, 75651
        • Hopital Pitie Salpetriere
      • Paris, France, 75571
        • Hopital Saint Antoine
      • Paris, France, 75015
        • Local Institution - 250
      • Paris, France, 75651
        • Local Institution - 259
      • Poitiers Cedex, France, 86021
        • CHU La Milétrie
      • Poitiers Cedex, France, 86021
        • Local Institution - 251
      • Toulose, France, 31059
        • Local Institution - 256
      • Toulose, France, 31059
        • Pole Des Specialites Medicales, Hopital Purpan
  • Germany
      • Bayern, Germany, 92637
        • Klinikum Weiden
      • Bayern, Germany, 92637
        • Local Institution - 280
      • Berlin, Germany, 12203
        • Charité - Universitätsmedizin Berlin
      • Berlin, Germany, 12203
        • Local Institution - 272
      • Dresden, Germany, D-01307
        • Universitätsklinikum Carl Gustav Carus an der TU Dresden
      • Dresden, Germany, D-01307
        • Local Institution - 278
      • Essen, Germany, 45136
        • Kliniken Essen-Mitte
      • Frankfurt, Germany, 60590
        • Local Institution - 277
      • Frankfurt, Germany, 60590
        • Universitätsklinkum Frankfurt
      • Frechen, Germany, 50226
        • Local Institution - 284
      • Frechen, Germany, 50226
        • Praxis Internistischer Onkologie und Hamatologie Frechen
      • Friedrichshafen, Germany, 88045
        • Local Institution - 275
      • Friedrichshafen, Germany, 88045
        • Praxis für Innere Medizin, Dr.Oettle Helmut
      • Greifswald, Germany, 17487
        • Ernst-Moritz-Arndt-Universität Greifswald
      • Greifswald, Germany, 17487
        • Local Institution - 279
      • Hamburg, Germany, 20246
        • Universitaetsklinik Hamburg - Eppendorf
      • Hamburg, Germany, 20246
        • Local Institution - 273
      • Köln, Germany, 50674
        • Local Institution - 281
      • Köln, Germany, 50674
        • Praxis Internistischer Onkologie und Hamatologie Koln
      • Magdeburg, Germany, 39108
        • Local Institution - 274
      • Magdeburg, Germany, 39108
        • Universitätsklinik Magdeburg
      • Mainz, Germany, 55131
        • Klinikum der Johannes Gutenberg Uniervsitaet ,Haematologie
      • Mainz, Germany, 55131
        • Local Institution - 283
      • München, Germany, 81377
        • Klinikum der Universität München-Großhadern
      • München, Germany, 81377
        • Local Institution - 282
      • München, Germany, 81737
        • Klinikum Neuperlach
      • München, Germany, 81737
        • Local Institution - 276
      • Tübingen, Germany, 72076
        • University of Tubingen
      • Tübingen, Germany, 72076
        • Local Institution - 0271
      • Würzburg, Germany, 97080
        • Universitätsklinikum Würzburg
      • Würzburg, Germany, 97080
        • Local Institution - 270
  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital
      • Hong Kong, Hong Kong
        • Tuen Mun Hospital
      • Hong Kong, Hong Kong
        • Local Institution - 601
      • Sha Tin, Hong Kong
        • Local Institution - 602
      • Sha Tin, Hong Kong
        • Prince of Wales Hospital The Chinese University of Hong Kong
  • Hungary
      • Budapest, Hungary, 1145
        • Uzsoki Utcai Kórház
      • Budapest, Hungary, 1097
        • Fovarosi Szent Istvan es Szent Laszlo Korhaz es Rendelointezet
      • Budapest, Hungary, 1097
        • Local Institution - 293
      • Budapest, Hungary, 1145
        • Local Institution - 291
      • Debrecen, Hungary, 4032
        • Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum
      • Debrecen, Hungary, 4032
        • Local Institution - 290
      • Gyor, Hungary, 9024
        • Local Institution - 292
      • Gyor, Hungary, 9024
        • Petz Aladar Megyei Oktato Korhaz,II. Belgyogyaszat
      • Szeged, Hungary, 6720
        • Local Institution - 295
      • Szeged, Hungary, 6720
        • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Szent-Gyorgyi Albert TE AOK Borgyogy
      • Szolnok, Hungary, 5004
        • Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Rendelőintézet
  • Ireland
      • Cork, Ireland
        • Cork University Hospital
      • Cork, Ireland, T12 DFK4
        • Local Institution - 311
      • Dublin 4, Ireland, 4
        • Local Institution - 310
      • Dublin 4, Ireland, 4
        • St Vincent's University Hospital
  • Italy
      • Ancona, Italy, 60020
        • Local Institution - 325
      • Ancona, Italy, 60020
        • Ospedali Riuniti Umberto I GM Lancisi
      • Bologna, Italy, 40138
        • Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
      • Bologna, Italy, 40138
        • Local Institution - 330
      • Firenze, Italy, 50134
        • Azienda Ospedaliero-Universitaria Careggi
      • Firenze, Italy, 50134
        • Local Institution - 328
      • Meldola, Italy, 47014
        • Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori (I.R.S.T.)
      • Meldola, Italy, 47014
        • Local Institution - 331
      • Milano, Italy, 20132
        • Ospedale San Raffaele s.r.l.
      • Milano, Italy, 20162
        • Azienda Ospedaliera Niguarda Cà Granda
      • Milano, Italy, 20132
        • Local Institution - 321
      • Milano, Italy, 20162
        • Local Institution - 322
      • Pisa, Italy, 56126
        • Azienda Ospedaliero-Universitaria Pisana
      • Pisa, Italy, 56126
        • Local Institution - 324
      • Reggio Emilia, Italy, 42100
        • Arcispedale Santa Maria Nuova
      • Reggio Emilia, Italy, 42100
        • Local Institution - 333
      • Roma, Italy, 00168
        • Policlinico Universitario Agostino Gemelli
      • Roma, Italy, 00144
        • Local Institution - 323
      • Roma, Italy, 00168
        • Local Institution - 327
      • Roma, Italy, 144
        • Istituto Nazionale Tumori Regina Elena
      • Rozzano (MI), Italy, 20089
        • Istituto Clinico Humanitas
      • Rozzano (MI), Italy, 20089
        • Local Institution - 326
      • San Giovanni Rotondo, Italy, 71013
        • IRCCS Casa Sollievo della Sofferenza
      • San Giovanni Rotondo, Italy, 71013
        • Local Institution - 332
      • Terni, Italy, 05100
        • Azienda Ospedaliera S Maria Di Terni
      • Verona, Italy, 37134
        • Azienda Ospedaliera Universitaria Integrata Di Verona
      • Verona, Italy, 37134
        • Local Institution - 320
    • Umbria
      • Terni, Umbria, Italy, 05100
        • Local Institution - 329
  • Korea, Republic of
      • Seoul, Korea, Republic of, 135-710
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 138-736
        • Asan Medical Center
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 03080
        • Local Institution - 641
      • Seoul, Korea, Republic of, 135-710
        • Local Institution - 642
      • Seoul, Korea, Republic of, 138-736
        • Local Institution - 640
  • Netherlands
      • Amsterdam, Netherlands, 1105
        • Academisch Medisch Centrum Amsterdam
      • Amsterdam, Netherlands, 1105
        • Local Institution - 400
      • Eindhoven, Netherlands, 5632 EJ
        • Catharina Hospital
      • Eindhoven, Netherlands, 5632 EJ
        • Local Institution - 403
      • Zwolle, Netherlands, 8011
        • Isala Klinieken
      • Zwolle, Netherlands, 8011
        • Local Institution - 402
  • Portugal
      • Lisboa, Portugal, 1500-650
        • Hospital da Luz
      • Lisboa, Portugal, 1069-639
        • Centro Hospitalar de Lisboa Central - Hospital de Santo António dos Capuchos
      • Lisboa, Portugal, 1069-639
        • Local Institution - 340
      • Lisboa, Portugal, 1500-650
        • Local Institution - 341
      • Porto, Portugal, 4200
        • Hospital de Sao Joao
      • Porto, Portugal, 4200
        • Local Institution - 342
  • Singapore
      • Singapore, Singapore, 119074
        • National University Hospital
      • Singapore, Singapore, 119074
        • Local Institution - 610
      • Singapore, Singapore, 169-610
        • Local Institution - 611
      • Singapore, Singapore, 169-610
        • National Cancer Center
  • Spain
      • Barcelona, Spain, 8035
        • Hospital Universitari Vall d'Hebron
      • Barcelona, Spain, 08035
        • Local Institution - 360
      • Barcelona, Spain, 08036
        • Clinic Barcelona Hospital Universitari
      • Barcelona, Spain, 08036
        • Local Institution - 363
      • Barcelona, Spain, 08907
        • Instituto Catalan de Oncologia-Hospital Duran
      • Barcelona, Spain, 08907
        • Local Institution - 370
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28041
        • Hospital 12 de Octubre
      • Madrid, Spain, 28007
        • Hospital General Gregorio Maranon
      • Madrid, Spain, 28007
        • Local Institution - 367
      • Madrid, Spain, 28034
        • Local Institution - 362
      • Madrid, Spain, 28034
        • Ramon y Cajal Univeresity Hospital
      • Madrid, Spain, 28040
        • Local Institution - 372
      • Madrid, Spain, 28041
        • Local Institution - 365
      • Madrid, Spain, 28050
        • Centro Integral
      • Madrid, Spain, 28050
        • Local Institution - 361
      • Malaga, Spain, 29010
        • Hospital General Carlos Haya
      • Malaga, Spain, 29010
        • Local Institution - 369
      • Pamplona/ Navarra, Spain, 31008
        • Complejo Hospitalario de Navarra
      • Pamplona/ Navarra, Spain, 31008
        • Local Institution - 368
      • Santander, Spain, 39008
        • Hospital Universitario Marques de Valdecilla
      • Santiago De Compostela, Spain, 15706
        • Hospital Clinico Universitario de Santiago de Compostela
      • Santiago De Compostela, Spain, 15706
        • Local Institution - 366
      • Sevilla, Spain, 41013
        • Hospital Virgen del Rocío
      • Sevilla, Spain, 41013
        • Local Institution - 364
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Local Institution - 371
  • Taiwan
      • Taichung, Taiwan, 40705
        • Taichung Veterans General Hospital
      • Taichung, Taiwan, 40705
        • Local Institution - 620
      • Tainan, Taiana, Taiwan, 704
        • Local Institution - 625
      • Tainan, Taiana, Taiwan, 704
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital
      • Taipei, Taiwan, 11490
        • Tri-Service General Hospital
      • Taipei, Taiwan, 11217
        • Local Institution - 623
      • Taipei, Taiwan, 114
        • Local Institution - 622
      • Taoyuan, Taiwan, 333
        • Chang Gung Medical Foundation-Linkou Branch
      • Taoyuan, Taiwan, 333
        • Local Institution - 624
      • Tapei, Taiwan, 10002
        • Local Institution - 621
      • Tapei, Taiwan, 10002
        • National Taiwan University Hospital
  • United Kingdom
      • Cambridge, United Kingdom, CB2 0QQ
        • Addenbrookes Hospital
      • Cambridge, United Kingdom, CB2 0QQ
        • Local Institution - 382
      • Glasgow, United Kingdom, G11 6NT
        • Glasgow Royal Infirmary
      • Glasgow, United Kingdom, G11 6NT
        • Local Institution - 380
      • Sheffield, United Kingdom, S10 2SJ
        • Local Institution - 381
      • Sheffield South Yorkshire, United Kingdom, S10 2SS
        • Weston Park Hospital
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic - Arizona
      • Scottsdale, Arizona, United States, 85259
        • Local Institution - 043
    • California
      • La Jolla, California, United States, 92093
        • UCSD Moores Cancer Center
      • Los Angeles, California, United States, 90033
        • University of Southern California
      • Sacramento, California, United States, 95817
        • UC Davis Cancer Center
      • Sacramento, California, United States, 95817
        • Local Institution - 044
      • San Francisco, California, United States, 94110
        • Local Institution - 001
      • San Francisco, California, United States, 9411
        • University of California, San Francisco Cutaneous Oncology and Melanoma Center
      • Santa Monica, California, United States, 90404
        • University of California Los Angeles
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Cancer Center
      • Denver, Colorado, United States, 80218
        • Local Institution - 059
      • Denver, Colorado, United States, 80218
        • Rocky Mountain Cancer Centers, LLP [Denver-Midtown]
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale Cancer Center
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Lynn Cancer Institute
      • Boca Raton, Florida, United States, 33486
        • Local Institution - 022
      • Fort Myers, Florida, United States, 33916
        • Florida Cancer Institute Cancer Spec
      • Fort Myers, Florida, United States, 33916
        • Local Institution - 031
      • Gainesville, Florida, United States, 32610
        • University of Florida
      • Gainesville, Florida, United States, 32605
        • Gainesville Heme Oncology Associates
      • Gainesville, Florida, United States, 32610
        • Local Institution - 011
      • Miami, Florida, United States, 33136
        • University of Miami and Sylvester Cancer Center
      • Orlando, Florida, United States, 32804
        • Florida Hospital Cancer Institute
      • Orlando, Florida, United States, 32804
        • Local Institution - 039
      • Tampa, Florida, United States, 32207
        • H Lee Moffitt Cancer Center
    • Georgia
      • Atlanta, Georgia, United States, 30341
        • Georgia Cancer Specialist
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medical Center
      • Evanston, Illinois, United States, 60201
        • NorthShore University HealthSystem Research Institute
      • Niles, Illinois, United States, 60714
        • Illinois Cancer Specialists
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville
    • Louisiana
      • New Orleans, Louisiana, United States, 70121-2483
        • Ochsner Clinic Foundation
      • New Orleans, Louisiana, United States, 70121-2483
        • Ochsner Medical Center - Jefferson Highway
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute
      • Boston, Massachusetts, United States, 02115
        • Beth Israel-Deaconess Medical Center
      • Boston, Massachusetts, United States, 02115
        • Local Institution - 040
      • Boston, Massachusetts, United States, 02215
        • Local Institution - 045
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Local Institution - 036
      • Detroit, Michigan, United States, 48201
        • Karmanos Cancer Center Wayne State University
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
      • Rochester, Minnesota, United States, 55905
        • Local Institution - 021
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Nebraska Methodist Hospital
      • Omaha, Nebraska, United States, 68114
        • Local Institution - 048
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Local Institution - 064
      • Basking Ridge, New Jersey, United States, 07920
        • MSKCC Basking Ridge
      • Livingston, New Jersey, United States, 07039
        • Saint Barnabas Medical Center
    • New York
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute
      • Buffalo, New York, United States, 14263
        • Local Institution - 025
      • Commack, New York, United States, 11725
        • Memorial Sloan-Kettering Cancer Center
      • Harrison, New York, United States, 10604
        • Memorial Sloan Kettering Cancer Center West Harrison
      • Lake Success, New York, United States, 11042
        • NYU Langone Medical Center
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • New York, New York, United States, 10021-6007
        • Local Institution - 008
      • New York, New York, United States, 10021-6007
        • Memorial Sloan-Kettering Cancer Center - NYC
      • New York, New York, United States, 10032
        • Local Institution - 032
      • Rochester, New York, United States, 14642
        • Local Institution - 013
      • Rochester, New York, United States, 14642
        • University of Rochester Cancer Center, James P. Wilmot Cancer Center
      • Rockville Center, New York, United States, 11570
        • Local Institution - 066
      • Rockville Center, New York, United States, 11570
        • MSKCC at Mercy Medical Center Mercy RockvilleCenter
      • Sleepy Hollow, New York, United States, 10591
        • MSKCC at Phelps Memorial Hospital Center. Phelps Sleepy Hollow
      • Syracuse, New York, United States, 13215
        • State University of New York Upstate Medical Center
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157-1082
        • Local Institution - 051
      • Winston-Salem, North Carolina, United States, 27157-1082
        • Wake Forest Univ. Health Sciences Outpatient Comprehensive Cancer Center
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Oncology Hematology Care, Inc.
      • Cincinnati, Ohio, United States, 45242
        • Local Institution - 030
      • Cincinnati, Ohio, United States, 45267-0501
        • University of Cincinnati Medical CenterDivsion of Hematology OncologyThe Barrett Center
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic - Taussig Cancer Institute
      • Cleveland, Ohio, United States, 44106
        • Case Western Reserve Center
      • Cleveland, Ohio, United States, 44106
        • Local Institution - 047
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation IRB
      • Cleveland, Ohio, United States, 44195
        • Local Institution - 020
      • Cleveland, Ohio, United States, 44195
        • Local Institution - 054
      • Columbus, Ohio, United States, 43210
        • Ohio State University Medical Center
      • Columbus, Ohio, United States, 43210
        • Local Institution - 005
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Peggy and Charles Stephenson Cancer Center
      • Oklahoma City, Oklahoma, United States, 73104
        • Local Institution - 049
    • Oregon
      • Portland, Oregon, United States, 97239
        • Local Institution - 019
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University OHSU
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
      • Philadelphia, Pennsylvania, United States, 19107
        • Local Institution - 016
      • Pittsburgh, Pennsylvania, United States, 15232
        • Local Institution - 027
      • Pittsburgh, Pennsylvania, United States, 15232
        • UPMC Cancer Pavillion
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Chattanooga Oncology Hematology Care
      • Chattanooga, Tennessee, United States, 37404
        • Local Institution - 023
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Inst
      • Nashville, Tennessee, United States, 37203
        • Local Institution - 004
      • Nashville, Tennessee, United States, 37232-6307
        • Local Institution - 002
      • Nashville, Tennessee, United States, 37232-6307
        • Vanderbilt- Ingram Cancer Center
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center
      • Dallas, Texas, United States, 75246
        • Baylor Sammons Cancer Center
      • Dallas, Texas, United States, 75230
        • Texas Oncology
      • Dallas, Texas, United States, 75246
        • Local Institution - 062
      • Dallas, Texas, United States, 75390
        • Local Institution - 010
      • Fort Worth, Texas, United States, 76104
        • The Center for Cancer and Blood Disorders - Fort Worth
      • Fort Worth, Texas, United States, 76104
        • Local Institution - 050
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • Houston, Texas, United States, 77030
        • Local Institution - 041
      • Tyler, Texas, United States, 75702
        • Texas Oncology, P.A. - Tyler
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia
      • Charlottesville, Virginia, United States, 22908
        • Local Institution - 038
    • Washington
      • Seattle, Washington, United States, 98109
        • Local Institution - 003
      • Seattle, Washington, United States, 98109
        • Seattle Cancer Care Alliance - Seattle
      • Seattle, Washington, United States, 98111
        • Virginia Mason Cancer Center
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Local Institution - 014
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin - Madison Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1). Subjects with neuroendocrine (and mixed type) tumors are excluded.
  2. Pancreatic cancer surgical staging: Tumor (T) 1-3, Lymph Node (LN) N0-1, Metastasis (M) 0.
  3. Subject should be able to start treatment no later than 12 weeks postsurgery.
  4. ≥18 years of age at the time of signing the informed consent form (ICF).
  5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

  6. Acceptable hematology parameters:

    • Absolute neutrophil count (ANC) ≥1500 cell/mm^3
    • Platelet count ≥100,000/mm^3
    • Hemoglobin (Hgb) ≥9 g/dL

  7. 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
  8. Cancer antigen (CA)19-9 <100 U/mL assessed within 14 days of randomization
  9. Acceptable coagulation studies as demonstrated by prothrombin time (PT) and partial thromboplastin time (PTT) within normal limits (±15%)

Exclusion Criteria:

A subject will not be eligible for inclusion in this study if any of the following criteria apply:

  1. Prior neo-adjuvant treatment or radiation therapy for pancreatic adenocarcinoma
  2. Presence of or history of metastatic pancreatic adenocarcinoma
  3. 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)
  4. 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
  5. 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
  6. History of allergy or hypersensitivity to nab-paclitaxel or gemcitabine or any of their excipients

  7. 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:

    1. History of connective tissue disorders (eg, lupus, scleroderma, arteritis nodosa)
    2. History of interstitial lung disease, slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies
    3. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: nab-Paclitaxel 125 mg/m^2 plus gemcitabine 1000 mg/m2
Participants 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.
Drug: nab-Paclitaxel
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.
Other Names:
  • Abraxane
Drug: Gemcitabine
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.
Other Names:
  • Gemzar
Active Comparator: Gemcitabine 1000 mg/m^2
Participants 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.
Drug: Gemcitabine
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.
Other Names:
  • Gemzar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Kaplan Meier Estimate of Overall Survival (OS)
Time Frame: 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
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.
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
Number of Participants With Treatment Emergent Adverse Events (TEAE's)
Time Frame: 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).
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).
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).
The Number of Participants With Clinical Chemistry Laboratory-Detected Abnormalities (Grade 3-4)
Time Frame: 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).
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).
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celgene

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2014

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

October 14, 2013

First Submitted That Met QC Criteria

October 14, 2013

First Posted (Estimated)

October 17, 2013

Study Record Updates

Last Update Posted (Actual)

June 28, 2023

Last Update Submitted That Met QC Criteria

June 13, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABI-007-PANC-003
  • 2013-003398-91 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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