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

Neoplasms Clinical Trial

— apact  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01964430
• Other study ID #: ABI-007-PANC-003
• Secondary ID: 2013-003398-91
• Status: Completed
• Phase: Phase 3
• Start date: March 28, 2014
• Est. completion date: June 30, 2022

Study information

• Verified date: June 2023
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 866
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Antimetabolites, Antineoplastic
• Digestive System Diseases
• Digestive System Neoplasms
• Endocrine Gland Neoplasms
• Endocrine System Diseases
• Gastrointestinal Diseases
• Gastrointestinal Neoplasms
• Gemcitabine
• Neoplasms
• Neoplasms by Site
• Pancreatic Diseases
• Pancreatic Neoplasms

Intervention

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.
• 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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  Czechia,  Denmark,  Finland,  France,  Germany,  Hong Kong,  Hungary,  Ireland,  Italy,  Korea, Republic of,  Netherlands,  Portugal,  Singapore,  Spain,  Taiwan,  United Kingdom, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Kaplan Meier Estimate of Overall Survival (OS)	Overall survival was defined as the time from the date of randomization to the date of death. Participants who were alive at the end of study or clinical data cut were censored on the last-known-to-be-alive date or the clinical cutoff date, whichever was earlier.	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
Secondary	Number of Participants With Treatment Emergent Adverse Events (TEAE's)	TEAEs are defined as any adverse event (AE) that begin or worsen on or after the start of study drug or procedure of the study period through the maximum duration of the period plus 28 days. The severity of AEs was graded based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 and the scale: Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death. Relation to study drug was determined by the investigator. A treatment-related TEAE is defined as TEAE which was considered to be related to one or both of the study drugs and reported as 'Suspected' on the case report form. AEs with a missing relationship were treated as 'treatment-related' in data summaries. IP (investigational product) refers to nab-Paclitaxel and/or Gemcitabine. "Related" TEAE refers to relation to study drug (IP).	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).
Secondary	The Number of Participants With Clinical Chemistry Laboratory-Detected Abnormalities (Grade 3-4)	The number of participants with grade 3-4 laboratory abnormalities in selected clinically significant parameters. Grades for chemistry parameters were coded using National Cancer Institute Common Terminology Criteria for Adverse Events (Grade 3= severe, Grade 4= life-threatening).	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).

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