Nab-paclitaxel and Gemcitabine vs Gemcitabine Alone as Adjuvant Therapy for Patients With Resected Pancreatic Cancer (the "Apact" Study)
apact
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
2 other identifiers
interventional
866
20 countries
320
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2014
Longer than P75 for phase_3
320 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 14, 2013
CompletedFirst Posted
Study publicly available on registry
October 17, 2013
CompletedStudy Start
First participant enrolled
March 28, 2014
CompletedResults Posted
Study results publicly available
January 6, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedJune 28, 2023
June 1, 2023
8.3 years
October 14, 2013
December 17, 2019
June 13, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
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)
Kaplan Meier Estimate of Overall Survival (OS)
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)
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)
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).
Study Arms (2)
nab-Paclitaxel 125 mg/m^2 plus gemcitabine 1000 mg/m2
EXPERIMENTALParticipants 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.
Gemcitabine 1000 mg/m^2
ACTIVE 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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:
- 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
- +1 more criteria
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Celgenelead
Study Sites (341)
Local Institution - 043
Scottsdale, Arizona, 85259, United States
Mayo Clinic - Arizona
Scottsdale, Arizona, 85259, United States
UCSD Moores Cancer Center
La Jolla, California, 92093, United States
University of Southern California
Los Angeles, California, 90033, United States
Local Institution - 044
Sacramento, California, 95817, United States
UC Davis Cancer Center
Sacramento, California, 95817, United States
Local Institution - 001
San Francisco, California, 94110, United States
University of California, San Francisco Cutaneous Oncology and Melanoma Center
San Francisco, California, 9411, United States
University of California Los Angeles
Santa Monica, California, 90404, United States
University of Colorado Cancer Center
Aurora, Colorado, 80045, United States
Local Institution - 059
Denver, Colorado, 80218, United States
Rocky Mountain Cancer Centers, LLP [Denver-Midtown]
Denver, Colorado, 80218, United States
Yale Cancer Center
New Haven, Connecticut, 06510, United States
Local Institution - 022
Boca Raton, Florida, 33486, United States
Lynn Cancer Institute
Boca Raton, Florida, 33486, United States
Florida Cancer Institute Cancer Spec
Fort Myers, Florida, 33916, United States
Local Institution - 031
Fort Myers, Florida, 33916, United States
Gainesville Heme Oncology Associates
Gainesville, Florida, 32605, United States
Local Institution - 011
Gainesville, Florida, 32610, United States
University of Florida
Gainesville, Florida, 32610, United States
University of Miami and Sylvester Cancer Center
Miami, Florida, 33136, United States
Florida Hospital Cancer Institute
Orlando, Florida, 32804, United States
Local Institution - 039
Orlando, Florida, 32804, United States
H Lee Moffitt Cancer Center
Tampa, Florida, 32207, United States
Georgia Cancer Specialist
Atlanta, Georgia, 30341, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Northshore University Healthsystem Research Institute
Evanston, Illinois, 60201, United States
Illinois Cancer Specialists
Niles, Illinois, 60714, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121-2483, United States
Ochsner Medical Center - Jefferson Highway
New Orleans, Louisiana, 70121-2483, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beth Israel-Deaconess Medical Center
Boston, Massachusetts, 02115, United States
Local Institution - 040
Boston, Massachusetts, 02115, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Local Institution - 045
Boston, Massachusetts, 02215, United States
Local Institution - 036
Ann Arbor, Michigan, 48109, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Karmanos Cancer Center Wayne State University
Detroit, Michigan, 48201, United States
Local Institution - 021
Rochester, Minnesota, 55905, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Local Institution - 048
Omaha, Nebraska, 68114, United States
Nebraska Methodist Hospital
Omaha, Nebraska, 68114, United States
Local Institution - 064
Basking Ridge, New Jersey, 07920, United States
MSKCC Basking Ridge
Basking Ridge, New Jersey, 07920, United States
Saint Barnabas Medical Center
Livingston, New Jersey, 07039, United States
Local Institution - 025
Buffalo, New York, 14263, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Memorial Sloan-Kettering Cancer Center
Commack, New York, 11725, United States
Memorial Sloan Kettering Cancer Center West Harrison
Harrison, New York, 10604, United States
NYU Langone Medical Center
Lake Success, New York, 11042, United States
Local Institution - 008
New York, New York, 10021-6007, United States
Memorial Sloan-Kettering Cancer Center - NYC
New York, New York, 10021-6007, United States
Columbia University Medical Center
New York, New York, 10032, United States
Local Institution - 032
New York, New York, 10032, United States
Local Institution - 013
Rochester, New York, 14642, United States
University of Rochester Cancer Center, James P. Wilmot Cancer Center
Rochester, New York, 14642, United States
Local Institution - 066
Rockville Centre, New York, 11570, United States
MSKCC at Mercy Medical Center Mercy RockvilleCenter
Rockville Centre, New York, 11570, United States
MSKCC at Phelps Memorial Hospital Center. Phelps Sleepy Hollow
Sleepy Hollow, New York, 10591, United States
State University of New York Upstate Medical Center
Syracuse, New York, 13215, United States
Local Institution - 051
Winston-Salem, North Carolina, 27157-1082, United States
Wake Forest Univ. Health Sciences Outpatient Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157-1082, United States
Local Institution - 030
Cincinnati, Ohio, 45242, United States
Oncology Hematology Care, Inc.
Cincinnati, Ohio, 45242, United States
University of Cincinnati Medical CenterDivsion of Hematology OncologyThe Barrett Center
Cincinnati, Ohio, 45267-0501, United States
Case Western Reserve Center
Cleveland, Ohio, 44106, United States
Local Institution - 047
Cleveland, Ohio, 44106, United States
Cleveland Clinic - Taussig Cancer Institute
Cleveland, Ohio, 44195, United States
Cleveland Clinic Foundation IRB
Cleveland, Ohio, 44195, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Local Institution - 020
Cleveland, Ohio, 44195, United States
Local Institution - 054
Cleveland, Ohio, 44195, United States
Local Institution - 005
Columbus, Ohio, 43210, United States
Ohio State University Medical Center
Columbus, Ohio, 43210, United States
Local Institution - 049
Oklahoma City, Oklahoma, 73104, United States
University of Oklahoma Peggy and Charles Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104, United States
Local Institution - 019
Portland, Oregon, 97239, United States
Oregon Health and Science University OHSU
Portland, Oregon, 97239, United States
Local Institution - 016
Philadelphia, Pennsylvania, 19107, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Local Institution - 027
Pittsburgh, Pennsylvania, 15232, United States
UPMC Cancer Pavillion
Pittsburgh, Pennsylvania, 15232, United States
Chattanooga Oncology Hematology Care
Chattanooga, Tennessee, 37404, United States
Local Institution - 023
Chattanooga, Tennessee, 37404, United States
Local Institution - 004
Nashville, Tennessee, 37203, United States
Sarah Cannon Research Inst
Nashville, Tennessee, 37203, United States
Local Institution - 002
Nashville, Tennessee, 37232-6307, United States
Vanderbilt- Ingram Cancer Center
Nashville, Tennessee, 37232-6307, United States
Texas Oncology
Dallas, Texas, 75230, United States
Baylor Sammons Cancer Center
Dallas, Texas, 75246, United States
Local Institution - 062
Dallas, Texas, 75246, United States
Local Institution - 010
Dallas, Texas, 75390, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
Local Institution - 050
Fort Worth, Texas, 76104, United States
The Center for Cancer and Blood Disorders - Fort Worth
Fort Worth, Texas, 76104, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Local Institution - 041
Houston, Texas, 77030, United States
Texas Oncology, P.A. - Tyler
Tyler, Texas, 75702, United States
Local Institution - 038
Charlottesville, Virginia, 22908, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
Local Institution - 003
Seattle, Washington, 98109, United States
Seattle Cancer Care Alliance - Seattle
Seattle, Washington, 98109, United States
Virginia Mason Cancer Center
Seattle, Washington, 98111, United States
Local Institution - 014
Madison, Wisconsin, 53792, United States
University of Wisconsin - Madison Cancer Center
Madison, Wisconsin, 53792, United States
Canberra Hospital
Garran, Australian Capital Territory, 2605, Australia
Local Institution - 505
Garran, Australian Capital Territory, 2605, Australia
Local Institution - 501
Darlinghurst, New South Wales, 2010, Australia
Local Institution - 507
St Leonards, New South Wales, 2065, Australia
Northern Cancer Institute
St Leonards, New South Wales, 2065, Australia
Local Institution - 504
Herston, Queensland, 4029, Australia
ICON Cancer Center
Milton, Queensland, 4064, Australia
Local Institution - 502
Milton, Queensland, 4064, Australia
Local Institution - 506
Bentleigh East, Victoria, 3165, Australia
Local Institution - 508
Subiaco, Western Australia, 6008, Australia
St John of God Subiaco Hospital
Subiaco, Western Australia, 6008, Australia
Monash Medical Centre Moorabbin Campus
Bentleigh East, 3165, Australia
Saint Vincent's Hospital
Darlinghurst, 2010, Australia
Austin Hospital
Heidelberg, 3084, Australia
Local Institution - 509
Heidelberg, 3084, Australia
Royal Brisbane and Women's Hospital
Herston, 4029, Australia
Cabrini Hospital
Malvern, 3144, Australia
Local Institution - 503
Malvern, 3144, Australia
Local Institution - 500
Randwick, 2031, Australia
Prince of Wales Hospital
Randwick, 2031, Australia
The Queen Elizabeth Hospital
Woodville South, 5011, Australia
Local Institution - 205
Graz, 8036, Austria
Medical University of Graz
Graz, A-8036, Austria
Local Institution - 203
Innsbruck, 6020, Austria
Medical University Innsbruck
Innsbruck, 6020, Austria
Hospital of Elisabethinen Linz
Linz, 4010, Austria
Local Institution - 206
Linz, 4010, Austria
Local Institution - 204
Salzburg, 5020, Austria
Salzburger Landkliniken St. Johanns-Spital
Salzburg, 5020, Austria
Local Institution - 200
Vienna, 1090, Austria
Medizinische Universitat Wien
Vienna, 1090, Austria
Kaiser-Franz-Josef Spital
Vienna, 1100, Austria
Local Institution - 201
Vienna, 1100, Austria
Klinikum Wels-Grieskirchen GmbH
Wels, 4600, Austria
Local Institution - 0207
Wels, 4600, Austria
Hospital Wiener Neustadt
Wiener Neustadt, 2700, Austria
Local Institution - 202
Wiener Neustadt, 2700, Austria
Hopital Erasme
Brussels, 1070, Belgium
Local Institution - 211
Brussels, 1070, Belgium
UZ Antwerpen
Edegem, 2650, Belgium
Local Institution - 213
Ghent, 9000, Belgium
UZ Gent
Ghent, 9000, Belgium
Local Institution - 210
Leuven, 3000, Belgium
UZ Leuven
Leuven, 3000, Belgium
Local Institution - 102
Calgary, Alberta, T2N 4N2, Canada
Tom Baker Cancer Center
Calgary, Alberta, T2N 4N2, Canada
Local Institution - 101
Toronto, Ontario, M4N 3M5, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
Local Institution - 100
Toronto, Ontario, M5G 2M9, Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
Centre Hospitalier de L'Universite de Montreal St-Luc
Montreal, Quebec, H2X 3J4, Canada
Local Institution - 104
Montreal, Quebec, H2X 3J4, Canada
Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
Local Institution - 103
Montreal, Quebec, H3T 1E2, Canada
Fakultni nemocnice Hradec Kralove
Hradec KrĂ¡lovĂ©, 500 05, Czechia
Local Institution - 220
Hradec KrĂ¡lovĂ©, 500 05, Czechia
Krajska nemocnice Liberec, a.s.
Liberec, 460 63, Czechia
Krajska nemocnice T. Bati a.s.
ZlĂn, 762 75, Czechia
Local Institution - 221
ZlĂn, 762 75, Czechia
Hæmatologisk afd. B Aalborg Sygehus Syd
Aalborg, 9000, Denmark
Local Institution - 231
Aalborg, 9000, Denmark
Herlev Hospital
Herlev, 2730, Denmark
Local Institution - 232
Herlev, 2730, Denmark
Local Institution - 230
Odense C, 5000, Denmark
Onk.Dep., Odense Universitets hospital
Odense C, 5000, Denmark
Local Institution - 240
Tampere, Oulun Lääni, FI-33520, Finland
Helsingin yliopistollinen keskussairaala
Helsinki, FI-00290, Finland
Local Institution - 241
Helsinki, FI-00290, Finland
Tampereen yliopistollinen sairaala
Tampere, 33521, Finland
Local Institution - 242
Turku, 20521, Finland
Turku University Hospital
Turku, 20521, Finland
Center Hospitalier Universitaire d' Angers
Angers, 49033, France
Local Institution - 253
Angers, 49033, France
Hopital Henri Mondor
Créteil, 94010, France
CHRU de Lille France
Lille, 59037, France
Local Institution - 257
Lille, 59037, France
Hopital prive Jean Mermoz
Lyon, 69008, France
Local Institution - 252
Lyon, 69008, France
Hopital Edouard Herriot - Hepato-gastroenterologie
Lyon, 69437, France
Local Institution - 258
Lyon, 69437, France
Hopital Europeen Georges Pompidou
Paris, 75015, France
Local Institution - 250
Paris, 75015, France
Hopital Saint Antoine
Paris, 75571, France
Hopital Pitie Salpetriere
Paris, 75651, France
Local Institution - 259
Paris, 75651, France
CHU La Miletrie
Poitiers, 86021, France
Local Institution - 251
Poitiers, 86021, France
Local Institution - 256
Toulose, 31059, France
Pole Des Specialites Medicales, Hopital Purpan
Toulose, 31059, France
Klinikum Weiden
Bayern, 92637, Germany
Local Institution - 280
Bayern, 92637, Germany
Charite - Universitätsmedizin Berlin
Berlin, 12203, Germany
Local Institution - 272
Berlin, 12203, Germany
Local Institution - 281
Cologne, 50674, Germany
Praxis Internistischer Onkologie und Hamatologie Koln
Cologne, 50674, Germany
Local Institution - 278
Dresden, D-01307, Germany
Universitatsklinikum Carl Gustav Carus an der TU Dresden
Dresden, D-01307, Germany
Kliniken Essen-Mitte
Essen, 45136, Germany
Local Institution - 277
Frankfurt, 60590, Germany
Universitatsklinkum Frankfurt
Frankfurt, 60590, Germany
Local Institution - 284
Frechen, 50226, Germany
Praxis Internistischer Onkologie und Hamatologie Frechen
Frechen, 50226, Germany
Local Institution - 275
Friedrichshafen, 88045, Germany
Praxis fĂ¼r Innere Medizin, Dr.Oettle Helmut
Friedrichshafen, 88045, Germany
Ernst-Moritz-Arndt-Universität Greifswald
Greifswald, 17487, Germany
Local Institution - 279
Greifswald, 17487, Germany
Local Institution - 273
Hamburg, 20246, Germany
Universitaetsklinik Hamburg - Eppendorf
Hamburg, 20246, Germany
Local Institution - 274
Magdeburg, 39108, Germany
Universitatsklinik Magdeburg
Magdeburg, 39108, Germany
Klinikum der Johannes Gutenberg Uniervsitaet ,Haematologie
Mainz, 55131, Germany
Local Institution - 283
Mainz, 55131, Germany
Klinikum der Universitat Munchen-Grosshadern
MĂ¼nchen, 81377, Germany
Local Institution - 282
MĂ¼nchen, 81377, Germany
Klinikum Neuperlach
MĂ¼nchen, 81737, Germany
Local Institution - 276
MĂ¼nchen, 81737, Germany
Local Institution - 0271
TĂ¼bingen, 72076, Germany
University of Tubingen
TĂ¼bingen, 72076, Germany
Local Institution - 270
WĂ¼rzburg, 97080, Germany
Universitatsklinikum WĂ¼rzburg
WĂ¼rzburg, 97080, Germany
Local Institution - 601
Hong Kong, 0, Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Tuen Mun Hospital
Hong Kong, Hong Kong
Local Institution - 602
Shatin, 0, Hong Kong
Prince of Wales Hospital the Chinese University of Hong Kong
Shatin, Hong Kong
Fovarosi Szent Istvan es Szent Laszlo Korhaz es Rendelointezet
Budapest, 1097, Hungary
Local Institution - 293
Budapest, 1097, Hungary
Local Institution - 291
Budapest, 1145, Hungary
Uzsoki Utcai Korhaz
Budapest, 1145, Hungary
Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum
Debrecen, 4032, Hungary
Local Institution - 290
Debrecen, 4032, Hungary
Local Institution - 292
Győr, 9024, Hungary
Petz Aladar Megyei Oktato Korhaz,II. Belgyogyaszat
Győr, 9024, Hungary
Local Institution - 295
Szeged, 6720, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Szent-Gyorgyi Albert TE AOK Borgyogy
Szeged, 6720, Hungary
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet
Szolnok, 5004, Hungary
Local Institution - 311
Cork, T12 DFK4, Ireland
Cork University Hospital
Cork, Ireland
Local Institution - 310
Dublin, 4, Ireland
St Vincent's University Hospital
Dublin, 4, Ireland
Local Institution - 329
Terni, Umbria, 05100, Italy
Local Institution - 325
Ancona, 60020, Italy
Ospedali Riuniti Umberto I GM Lancisi
Ancona, 60020, Italy
Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
Bologna, 40138, Italy
Local Institution - 330
Bologna, 40138, Italy
Azienda Ospedaliero-Universitaria Careggi
Florence, 50134, Italy
Local Institution - 328
Florence, 50134, Italy
Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori (I.R.S.T.)
Meldola, 47014, Italy
Local Institution - 331
Meldola, 47014, Italy
Local Institution - 321
Milan, 20132, Italy
Ospedale San Raffaele S.r.l.
Milan, 20132, Italy
Azienda Ospedaliera Niguarda Ca Granda
Milan, 20162, Italy
Local Institution - 322
Milan, 20162, Italy
Azienda Ospedaliero-Universitaria Pisana
Pisa, 56126, Italy
Local Institution - 324
Pisa, 56126, Italy
Arcispedale Santa Maria Nuova
Reggio Emilia, 42100, Italy
Local Institution - 333
Reggio Emilia, 42100, Italy
Local Institution - 323
Roma, 00144, Italy
Local Institution - 327
Roma, 00168, Italy
Policlinico Universitario Agostino Gemelli
Roma, 00168, Italy
Istituto Nazionale Tumori Regina Elena
Roma, 144, Italy
Istituto Clinico Humanitas
Rozzano (MI), 20089, Italy
Local Institution - 326
Rozzano (MI), 20089, Italy
IRCCS Casa Sollievo della Sofferenza
San Giovanni Rotondo, 71013, Italy
Local Institution - 332
San Giovanni Rotondo, 71013, Italy
Azienda Ospedaliera S Maria di Terni
Terni, 05100, Italy
Azienda Ospedaliera Universitaria Integrata di Verona
Verona, 37134, Italy
Local Institution - 320
Verona, 37134, Italy
Academisch Medisch Centrum Amsterdam
Amsterdam, 1105, Netherlands
Local Institution - 400
Amsterdam, 1105, Netherlands
Catharina Hospital
Eindhoven, 5632 EJ, Netherlands
Local Institution - 403
Eindhoven, 5632 EJ, Netherlands
Isala Klinieken
Zwolle, 8011, Netherlands
Local Institution - 402
Zwolle, 8011, Netherlands
Centro Hospitalar de Lisboa Central - Hospital de Santo AntĂ³nio dos Capuchos
Lisbon, 1069-639, Portugal
Local Institution - 340
Lisbon, 1069-639, Portugal
Hospital Da Luz
Lisbon, 1500-650, Portugal
Local Institution - 341
Lisbon, 1500-650, Portugal
Hospital de Sao Joao
Porto, 4200, Portugal
Local Institution - 342
Porto, 4200, Portugal
Local Institution - 610
Singapore, 119074, Singapore
National University Hospital
Singapore, 119074, Singapore
Local Institution - 611
Singapore, 169-610, Singapore
National Cancer Center
Singapore, 169-610, Singapore
Local Institution - 641
Seoul, 03080, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Local Institution - 642
Seoul, 135-710, South Korea
Samsung Medical Center
Seoul, 135-710, South Korea
Asan Medical Center
Seoul, 138-736, South Korea
Local Institution - 640
Seoul, 138-736, South Korea
Local Institution - 371
Santander, Cantabria, 39008, Spain
Local Institution - 360
Barcelona, 08035, Spain
Clinic Barcelona Hospital Universitari
Barcelona, 08036, Spain
Local Institution - 363
Barcelona, 08036, Spain
Instituto Catalan de Oncologia-Hospital Duran
Barcelona, 08907, Spain
Local Institution - 370
Barcelona, 08907, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 8035, Spain
Hospital General Gregorio Maranon
Madrid, 28007, Spain
Local Institution - 367
Madrid, 28007, Spain
Local Institution - 362
Madrid, 28034, Spain
Ramon y Cajal Univeresity Hospital
Madrid, 28034, Spain
Hospital Clinico San Carlos
Madrid, 28040, Spain
Local Institution - 372
Madrid, 28040, Spain
Hospital 12 de Octubre
Madrid, 28041, Spain
Local Institution - 365
Madrid, 28041, Spain
Centro Integral
Madrid, 28050, Spain
Local Institution - 361
Madrid, 28050, Spain
Hospital General Carlos Haya
MĂ¡laga, 29010, Spain
Local Institution - 369
MĂ¡laga, 29010, Spain
Complejo Hospitalario de Navarra
Pamplona/ Navarra, 31008, Spain
Local Institution - 368
Pamplona/ Navarra, 31008, Spain
Hospital Universitario Marques de Valdecilla
Santander, 39008, Spain
Hospital Clinico Universitario De Santiago De Compostela
Santiago de Compostela, 15706, Spain
Local Institution - 366
Santiago de Compostela, 15706, Spain
Hospital Virgen del Rocio
Seville, 41013, Spain
Local Institution - 364
Seville, 41013, Spain
Local Institution - 620
Taichung, 40705, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
Local Institution - 625
Tainan, Taiana, 704, Taiwan
National Cheng Kung University Hospital
Tainan, Taiana, 704, Taiwan
Local Institution - 623
Taipei, 11217, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Tri-Service General Hospital
Taipei, 11490, Taiwan
Local Institution - 622
Taipei, 114, Taiwan
Chang Gung Medical Foundation-Linkou Branch
Taoyuan District, 333, Taiwan
Local Institution - 624
Taoyuan District, 333, Taiwan
Local Institution - 621
Tapei, 10002, Taiwan
National Taiwan University Hospital
Tapei, 10002, Taiwan
Addenbrookes Hospital
Cambridge, CB2 0QQ, United Kingdom
Local Institution - 382
Cambridge, CB2 0QQ, United Kingdom
Glasgow Royal Infirmary
Glasgow, G11 6NT, United Kingdom
Local Institution - 380
Glasgow, G11 6NT, United Kingdom
Local Institution - 381
Sheffield, S10 2SJ, United Kingdom
Weston Park Hospital
Sheffield South Yorkshire, S10 2SS, United Kingdom
Related Publications (6)
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.
PMID: 29932294BACKGROUNDReni 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.
PMID: 30149366BACKGROUNDFernandez 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.
PMID: 30497432BACKGROUNDSonbol 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.
PMID: 30768369BACKGROUNDTempero 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.
PMID: 36521097DERIVEDReni 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.
PMID: 33813673DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 14, 2013
First Posted
October 17, 2013
Study Start
March 28, 2014
Primary Completion
June 30, 2022
Study Completion
June 30, 2022
Last Updated
June 28, 2023
Results First Posted
January 6, 2020
Record last verified: 2023-06