Clinical trial NCT01964430: Nab-paclitaxel and Gemcitabine vs Gemcitabine Alone as Adjuvant Therapy for Patients With Resected Pancreatic Cancer (the "Apact" 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Digestive System Diseases
Endocrine System Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Keywords: Resectable pancreatic cancer
resected
resectable PDA
adenocarcinoma
surgically resected
adjuvant
Abraxane
nab-paclitaxel
ABI-007
gemcitabine
Gemzar
Phase 3
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2013-10-17
Enrollment: 866
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Kaplan Meier Estimate for Disease Free Survival (DFS) According to the Independent Radiological Review Committee
timeFrame: 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:
measure: Kaplan Meier Estimate of Overall Survival (OS)
timeFrame: 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
measure: Number of Participants With Treatment Emergent Adverse Events (TEAE's)
timeFrame: 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).
measure: The Number of Participants With Clinical Chemistry Laboratory-Detected Abnormalities (Grade 3-4)
timeFrame: 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).
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Local Institution - 043
state: Arizona
city: Scottsdale
country: United States
facility: Mayo Clinic - Arizona
state: Arizona
city: La Jolla
country: United States
facility: UCSD Moores Cancer Center
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Sacramento
country: United States
facility: Local Institution - 044
state: California
city: Sacramento
country: United States
facility: UC Davis Cancer Center
state: California
city: San Francisco
country: United States
facility: Local Institution - 001
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco Cutaneous Oncology and Melanoma Center
state: California
city: Santa Monica
country: United States
facility: University of California Los Angeles
state: California
city: Aurora
country: United States
facility: University of Colorado Cancer Center
state: Colorado
city: Denver
country: United States
facility: Local Institution - 059
state: Colorado
city: Denver
country: United States
facility: Rocky Mountain Cancer Centers, LLP [Denver-Midtown]
state: Colorado
city: New Haven
country: United States
facility: Yale Cancer Center
state: Connecticut
city: Boca Raton
country: United States
facility: Local Institution - 022
state: Florida
city: Boca Raton
country: United States
facility: Lynn Cancer Institute
state: Florida
city: Fort Myers
country: United States
facility: Florida Cancer Institute Cancer Spec
state: Florida
city: Fort Myers
country: United States
facility: Local Institution - 031
state: Florida
city: Gainesville
country: United States
facility: Gainesville Heme Oncology Associates
state: Florida
city: Gainesville
country: United States
facility: Local Institution - 011
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Miami
country: United States
facility: University of Miami and Sylvester Cancer Center
state: Florida
city: Orlando
country: United States
facility: Florida Hospital Cancer Institute
state: Florida
city: Orlando
country: United States
facility: Local Institution - 039
state: Florida
city: Tampa
country: United States
facility: H Lee Moffitt Cancer Center
state: Florida
city: Atlanta
country: United States
facility: Georgia Cancer Specialist
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Evanston
country: United States
facility: Northshore University Healthsystem Research Institute
state: Illinois
city: Niles
country: United States
facility: Illinois Cancer Specialists
state: Illinois
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Medical Center - Jefferson Highway
state: Louisiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel-Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Local Institution - 040
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Local Institution - 045
state: Massachusetts
city: Ann Arbor
country: United States
facility: Local Institution - 036
state: Michigan
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Karmanos Cancer Center Wayne State University
state: Michigan
city: Rochester
country: United States
facility: Local Institution - 021
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Omaha
country: United States
facility: Local Institution - 048
state: Nebraska
city: Omaha
country: United States
facility: Nebraska Methodist Hospital
state: Nebraska
city: Basking Ridge
country: United States
facility: Local Institution - 064
state: New Jersey
city: Basking Ridge
country: United States
facility: MSKCC Basking Ridge
state: New Jersey
city: Livingston
country: United States
facility: Saint Barnabas Medical Center
state: New Jersey
city: Buffalo
country: United States
facility: Local Institution - 025
state: New York
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Commack
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Cancer Center West Harrison
state: New York
city: Lake Success
country: United States
facility: NYU Langone Medical Center
state: New York
city: New York
country: United States
facility: Local Institution - 008
state: New York
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center - NYC
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: New York
country: United States
facility: Local Institution - 032
state: New York
city: Rochester
country: United States
facility: Local Institution - 013
state: New York
city: Rochester
country: United States
facility: University of Rochester Cancer Center, James P. Wilmot Cancer Center
state: New York
city: Rockville Center
country: United States
facility: Local Institution - 066
state: New York
city: Rockville Center
country: United States
facility: MSKCC at Mercy Medical Center Mercy RockvilleCenter
state: New York
city: Sleepy Hollow
country: United States
facility: MSKCC at Phelps Memorial Hospital Center. Phelps Sleepy Hollow
state: New York
city: Syracuse
country: United States
facility: State University of New York Upstate Medical Center
state: New York
city: Winston-Salem
country: United States
facility: Local Institution - 051
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Univ. Health Sciences Outpatient Comprehensive Cancer Center
state: North Carolina
city: Cincinnati
country: United States
facility: Local Institution - 030
state: Ohio
city: Cincinnati
country: United States
facility: Oncology Hematology Care, Inc.
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati Medical CenterDivsion of Hematology OncologyThe Barrett Center
state: Ohio
city: Cleveland
country: United States
facility: Case Western Reserve Center
state: Ohio
city: Cleveland
country: United States
facility: Local Institution - 047
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic - Taussig Cancer Institute
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation IRB
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Cleveland
country: United States
facility: Local Institution - 020
state: Ohio
city: Cleveland
country: United States
facility: Local Institution - 054
state: Ohio
city: Columbus
country: United States
facility: Local Institution - 005
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: Local Institution - 049
state: Oklahoma
city: Oklahoma City
country: United States
facility: University of Oklahoma Peggy and Charles Stephenson Cancer Center
state: Oklahoma
city: Portland
country: United States
facility: Local Institution - 019
state: Oregon
city: Portland
country: United States
facility: Oregon Health and Science University OHSU
state: Oregon
city: Philadelphia
country: United States
facility: Local Institution - 016
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Local Institution - 027
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Cancer Pavillion
state: Pennsylvania
city: Chattanooga
country: United States
facility: Chattanooga Oncology Hematology Care
state: Tennessee
city: Chattanooga
country: United States
facility: Local Institution - 023
state: Tennessee
city: Nashville
country: United States
facility: Local Institution - 004
state: Tennessee
city: Nashville
country: United States
facility: Sarah Cannon Research Inst
state: Tennessee
city: Nashville
country: United States
facility: Local Institution - 002
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt- Ingram Cancer Center
state: Tennessee
city: Dallas
country: United States
facility: Texas Oncology
state: Texas
city: Dallas
country: United States
facility: Baylor Sammons Cancer Center
state: Texas
city: Dallas
country: United States
facility: Local Institution - 062
state: Texas
city: Dallas
country: United States
facility: Local Institution - 010
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Fort Worth
country: United States
facility: Local Institution - 050
state: Texas
city: Fort Worth
country: United States
facility: The Center for Cancer and Blood Disorders - Fort Worth
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: Local Institution - 041
state: Texas
city: Tyler
country: United States
facility: Texas Oncology, P.A. - Tyler
state: Texas
city: Charlottesville
country: United States
facility: Local Institution - 038
state: Virginia
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Seattle
country: United States
facility: Local Institution - 003
state: Washington
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance - Seattle
state: Washington
city: Seattle
country: United States
facility: Virginia Mason Cancer Center
state: Washington
city: Madison
country: United States
facility: Local Institution - 014
state: Wisconsin
city: Madison
country: United States
facility: University of Wisconsin - Madison Cancer Center
state: Wisconsin
city: Garran
country: Australia
facility: Canberra Hospital
state: Australian Capital Territory
city: Garran
country: Australia
facility: Local Institution - 505
state: Australian Capital Territory
city: Darlinghurst
country: Australia
facility: Local Institution - 501
state: New South Wales
city: St Leonards
country: Australia
facility: Local Institution - 507
state: New South Wales
city: St Leonards
country: Australia
facility: Northern Cancer Institute
state: New South Wales
city: Herston
country: Australia
facility: Local Institution - 504
state: Queensland
city: Milton
country: Australia
facility: ICON Cancer Center
state: Queensland
city: Milton
country: Australia
facility: Local Institution - 502
state: Queensland
city: Bentleigh East
country: Australia
facility: Local Institution - 506
state: Victoria
city: Subiaco
country: Australia
facility: Local Institution - 508
state: Western Australia
city: Subiaco
country: Australia
facility: St John of God Subiaco Hospital
state: Western Australia
city: Bentleigh East
country: Australia
facility: Monash Medical Centre Moorabbin Campus
city: Darlinghurst
country: Australia
facility: Saint Vincent's Hospital
city: Heidelberg
country: Australia
facility: Austin Hospital
city: Heidelberg
country: Australia
facility: Local Institution - 509
city: Herston
country: Australia
facility: Royal Brisbane and Women's Hospital
city: Malvern
country: Australia
facility: Cabrini Hospital
city: Malvern
country: Australia
facility: Local Institution - 503
city: Randwick
country: Australia
facility: Local Institution - 500
city: Randwick
country: Australia
facility: Prince of Wales Hospital
city: Woodville South
country: Australia
facility: The Queen Elizabeth Hospital
city: Graz
country: Austria
facility: Local Institution - 205
city: Graz
country: Austria
facility: Medical University of Graz
city: Innsbruck
country: Austria
facility: Local Institution - 203
city: Innsbruck
country: Austria
facility: Medical University Innsbruck
city: Linz
country: Austria
facility: Hospital of Elisabethinen Linz
city: Linz
country: Austria
facility: Local Institution - 206
city: Salzburg
country: Austria
facility: Local Institution - 204
city: Salzburg
country: Austria
facility: Salzburger Landkliniken St. Johanns-Spital
city: Wels
country: Austria
facility: Klinikum Wels-Grieskirchen GmbH
city: Wels
country: Austria
facility: Local Institution - 0207
city: Wiener Neustadt
country: Austria
facility: Hospital Wiener Neustadt
city: Wiener Neustadt
country: Austria
facility: Local Institution - 202
city: Wien
country: Austria
facility: Local Institution - 200
city: Wien
country: Austria
facility: Medizinische Universitat Wien
city: Wien
country: Austria
facility: Kaiser-Franz-Josef Spital
city: Wien
country: Austria
facility: Local Institution - 201
city: Brussels
country: Belgium
facility: Hopital Erasme
city: Brussels
country: Belgium
facility: Local Institution - 211
city: Edegem
country: Belgium
facility: UZ Antwerpen
city: Gent
country: Belgium
facility: Local Institution - 213
city: Gent
country: Belgium
facility: UZ Gent
city: Leuven
country: Belgium
facility: Local Institution - 210
city: Leuven
country: Belgium
facility: UZ Leuven
city: Calgary
country: Canada
facility: Local Institution - 102
state: Alberta
city: Calgary
country: Canada
facility: Tom Baker Cancer Center
state: Alberta
city: Toronto
country: Canada
facility: Local Institution - 101
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Local Institution - 100
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Montreal
country: Canada
facility: Centre Hospitalier de L'Universite de Montreal St-Luc
state: Quebec
city: Montreal
country: Canada
facility: Local Institution - 104
state: Quebec
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Montreal
country: Canada
facility: Local Institution - 103
state: Quebec
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove
city: Hradec Kralove
country: Czechia
facility: Local Institution - 220
city: Liberec
country: Czechia
facility: Krajska nemocnice Liberec, a.s.
city: Zlin
country: Czechia
facility: Krajska nemocnice T. Bati a.s.
city: Zlin
country: Czechia
facility: Local Institution - 221
city: Aalborg
country: Denmark
facility: Hæmatologisk afd. B Aalborg Sygehus Syd
city: Aalborg
country: Denmark
facility: Local Institution - 231
city: Herlev
country: Denmark
facility: Herlev Hospital
city: Herlev
country: Denmark
facility: Local Institution - 232
city: Odense C
country: Denmark
facility: Local Institution - 230
city: Odense C
country: Denmark
facility: Onk.Dep., Odense Universitets hospital
city: Tampere
country: Finland
facility: Local Institution - 240
state: Oulun Lääni
city: Helsinki
country: Finland
facility: Helsingin yliopistollinen keskussairaala
city: Helsinki
country: Finland
facility: Local Institution - 241
city: Tampere
country: Finland
facility: Tampereen yliopistollinen sairaala
city: Turku
country: Finland
facility: Local Institution - 242
city: Turku
country: Finland
facility: Turku University Hospital
city: Angers cedex 09
country: France
facility: Center Hospitalier Universitaire d' Angers
city: Angers cedex 09
country: France
facility: Local Institution - 253
city: Creteil
country: France
facility: Hopital Henri Mondor
city: Lille
country: France
facility: CHRU de Lille France
city: Lille
country: France
facility: Local Institution - 257
city: Lyon Cedex 3
country: France
facility: Hopital Edouard Herriot - Hepato-gastroenterologie
city: Lyon Cedex 3
country: France
facility: Local Institution - 258
city: Lyon
country: France
facility: Hopital prive Jean Mermoz
city: Lyon
country: France
facility: Local Institution - 252
city: Paris
country: France
facility: Hopital Europeen Georges Pompidou
city: Paris
country: France
facility: Local Institution - 250
city: Paris
country: France
facility: Hopital Saint Antoine
city: Paris
country: France
facility: Hopital Pitie Salpetriere
city: Paris
country: France
facility: Local Institution - 259
city: Poitiers Cedex
country: France
facility: CHU La Miletrie
city: Poitiers Cedex
country: France
facility: Local Institution - 251
city: Toulose
country: France
facility: Local Institution - 256
city: Toulose
country: France
facility: Pole Des Specialites Medicales, Hopital Purpan
city: Bayern
country: Germany
facility: Klinikum Weiden
city: Bayern
country: Germany
facility: Local Institution - 280
city: Berlin
country: Germany
facility: Charite - Universitätsmedizin Berlin
city: Berlin
country: Germany
facility: Local Institution - 272
city: Dresden
country: Germany
facility: Local Institution - 278
city: Dresden
country: Germany
facility: Universitatsklinikum Carl Gustav Carus an der TU Dresden
city: Essen
country: Germany
facility: Kliniken Essen-Mitte
city: Frankfurt
country: Germany
facility: Local Institution - 277
city: Frankfurt
country: Germany
facility: Universitatsklinkum Frankfurt
city: Frechen
country: Germany
facility: Local Institution - 284
city: Frechen
country: Germany
facility: Praxis Internistischer Onkologie und Hamatologie Frechen
city: Friedrichshafen
country: Germany
facility: Local Institution - 275
city: Friedrichshafen
country: Germany
facility: Praxis für Innere Medizin, Dr.Oettle Helmut
city: Greifswald
country: Germany
facility: Ernst-Moritz-Arndt-Universität Greifswald
city: Greifswald
country: Germany
facility: Local Institution - 279
city: Hamburg
country: Germany
facility: Local Institution - 273
city: Hamburg
country: Germany
facility: Universitaetsklinik Hamburg - Eppendorf
city: Köln
country: Germany
facility: Local Institution - 281
city: Köln
country: Germany
facility: Praxis Internistischer Onkologie und Hamatologie Koln
city: Magdeburg
country: Germany
facility: Local Institution - 274
city: Magdeburg
country: Germany
facility: Universitatsklinik Magdeburg
city: Mainz
country: Germany
facility: Klinikum der Johannes Gutenberg Uniervsitaet ,Haematologie
city: Mainz
country: Germany
facility: Local Institution - 283
city: München
country: Germany
facility: Klinikum der Universitat Munchen-Grosshadern
city: München
country: Germany
facility: Local Institution - 282
city: München
country: Germany
facility: Klinikum Neuperlach
city: München
country: Germany
facility: Local Institution - 276
city: Tübingen
country: Germany
facility: Local Institution - 0271
city: Tübingen
country: Germany
facility: University of Tubingen
city: Würzburg
country: Germany
facility: Local Institution - 270
city: Würzburg
country: Germany
facility: Universitatsklinikum Würzburg
city: Hong Kong
country: Hong Kong
facility: Local Institution - 601
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Hong Kong
country: Hong Kong
facility: Tuen Mun Hospital
city: Sha Tin
country: Hong Kong
facility: Local Institution - 602
city: Sha Tin
country: Hong Kong
facility: Prince of Wales Hospital the Chinese University of Hong Kong
city: Budapest
country: Hungary
facility: Fovarosi Szent Istvan es Szent Laszlo Korhaz es Rendelointezet
city: Budapest
country: Hungary
facility: Local Institution - 293
city: Budapest
country: Hungary
facility: Local Institution - 291
city: Budapest
country: Hungary
facility: Uzsoki Utcai Korhaz
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum
city: Debrecen
country: Hungary
facility: Local Institution - 290
city: Gyor
country: Hungary
facility: Local Institution - 292
city: Gyor
country: Hungary
facility: Petz Aladar Megyei Oktato Korhaz,II. Belgyogyaszat
city: Szeged
country: Hungary
facility: Local Institution - 295
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Szent-Gyorgyi Albert TE AOK Borgyogy
city: Szolnok
country: Hungary
facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet
city: Cork
country: Ireland
facility: Local Institution - 311
city: Cork
country: Ireland
facility: Cork University Hospital
city: Dublin 4
country: Ireland
facility: Local Institution - 310
city: Dublin 4
country: Ireland
facility: St Vincent's University Hospital
city: Terni
country: Italy
facility: Local Institution - 329
state: Umbria
city: Ancona
country: Italy
facility: Local Institution - 325
city: Ancona
country: Italy
facility: Ospedali Riuniti Umberto I GM Lancisi
city: Bologna
country: Italy
facility: Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
city: Bologna
country: Italy
facility: Local Institution - 330
city: Firenze
country: Italy
facility: Azienda Ospedaliero-Universitaria Careggi
city: Firenze
country: Italy
facility: Local Institution - 328
city: Meldola
country: Italy
facility: Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori (I.R.S.T.)
city: Meldola
country: Italy
facility: Local Institution - 331
city: Milano
country: Italy
facility: Local Institution - 321
city: Milano
country: Italy
facility: Ospedale San Raffaele S.r.l.
city: Milano
country: Italy
facility: Azienda Ospedaliera Niguarda Ca Granda
city: Milano
country: Italy
facility: Local Institution - 322
city: Pisa
country: Italy
facility: Azienda Ospedaliero-Universitaria Pisana
city: Pisa
country: Italy
facility: Local Institution - 324
city: Reggio Emilia
country: Italy
facility: Arcispedale Santa Maria Nuova
city: Reggio Emilia
country: Italy
facility: Local Institution - 333
city: Roma
country: Italy
facility: Local Institution - 323
city: Roma
country: Italy
facility: Local Institution - 327
city: Roma
country: Italy
facility: Policlinico Universitario Agostino Gemelli
city: Roma
country: Italy
facility: Istituto Nazionale Tumori Regina Elena
city: Rozzano (MI)
country: Italy
facility: Istituto Clinico Humanitas
city: Rozzano (MI)
country: Italy
facility: Local Institution - 326
city: San Giovanni Rotondo
country: Italy
facility: IRCCS Casa Sollievo della Sofferenza
city: San Giovanni Rotondo
country: Italy
facility: Local Institution - 332
city: Terni
country: Italy
facility: Azienda Ospedaliera S Maria di Terni
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata di Verona
city: Verona
country: Italy
facility: Local Institution - 320
city: Seoul
country: Korea, Republic of
facility: Local Institution - 641
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Local Institution - 642
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Local Institution - 640
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum Amsterdam
city: Amsterdam
country: Netherlands
facility: Local Institution - 400
city: Eindhoven
country: Netherlands
facility: Catharina Hospital
city: Eindhoven
country: Netherlands
facility: Local Institution - 403
city: Zwolle
country: Netherlands
facility: Isala Klinieken
city: Zwolle
country: Netherlands
facility: Local Institution - 402
city: Lisboa
country: Portugal
facility: Centro Hospitalar de Lisboa Central - Hospital de Santo António dos Capuchos
city: Lisboa
country: Portugal
facility: Local Institution - 340
city: Lisboa
country: Portugal
facility: Hospital Da Luz
city: Lisboa
country: Portugal
facility: Local Institution - 341
city: Porto
country: Portugal
facility: Hospital de Sao Joao
city: Porto
country: Portugal
facility: Local Institution - 342
city: Singapore
country: Singapore
facility: Local Institution - 610
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: Local Institution - 611
city: Singapore
country: Singapore
facility: National Cancer Center
city: Santander
country: Spain
facility: Local Institution - 371
state: Cantabria
city: Barcelona
country: Spain
facility: Local Institution - 360
city: Barcelona
country: Spain
facility: Clinic Barcelona Hospital Universitari
city: Barcelona
country: Spain
facility: Local Institution - 363
city: Barcelona
country: Spain
facility: Instituto Catalan de Oncologia-Hospital Duran
city: Barcelona
country: Spain
facility: Local Institution - 370
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Madrid
country: Spain
facility: Hospital General Gregorio Maranon
city: Madrid
country: Spain
facility: Local Institution - 367
city: Madrid
country: Spain
facility: Local Institution - 362
city: Madrid
country: Spain
facility: Ramon y Cajal Univeresity Hospital
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Local Institution - 372
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Madrid
country: Spain
facility: Local Institution - 365
city: Madrid
country: Spain
facility: Centro Integral
city: Madrid
country: Spain
facility: Local Institution - 361
city: Malaga
country: Spain
facility: Hospital General Carlos Haya
city: Malaga
country: Spain
facility: Local Institution - 369
city: Pamplona/ Navarra
country: Spain
facility: Complejo Hospitalario de Navarra
city: Pamplona/ Navarra
country: Spain
facility: Local Institution - 368
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
city: Santiago De Compostela
country: Spain
facility: Hospital Clinico Universitario De Santiago De Compostela
city: Santiago De Compostela
country: Spain
facility: Local Institution - 366
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocio
city: Sevilla
country: Spain
facility: Local Institution - 364
city: Taichung
country: Taiwan
facility: Local Institution - 620
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan, Taiana
country: Taiwan
facility: Local Institution - 625
city: Tainan, Taiana
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: Local Institution - 623
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
city: Taipei
country: Taiwan
facility: Local Institution - 622
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation-Linkou Branch
city: Taoyuan
country: Taiwan
facility: Local Institution - 624
city: Tapei
country: Taiwan
facility: Local Institution - 621
city: Tapei
country: Taiwan
facility: National Taiwan University Hospital
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital
city: Cambridge
country: United Kingdom
facility: Local Institution - 382
city: Glasgow
country: United Kingdom
facility: Glasgow Royal Infirmary
city: Glasgow
country: United Kingdom
facility: Local Institution - 380
city: Sheffield South Yorkshire
country: United Kingdom
facility: Weston Park Hospital
city: Sheffield
country: United Kingdom
facility: Local Institution - 381
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.