Clinical trial NCT04083235: A Study to Assess the Effectiveness and Safety of Irinotecan Liposome Injection, 5-fluorouracil/Leucovorin Plus Oxaliplatin in Patients Not Previously Treated for Metastatic Pancreatic Cancer, Compared to Nab-paclitaxel+Gemcitabine Treatment
Official title: An Open-label, Randomised, Multicentre, Phase III Study of Irinotecan Liposome Injection, Oxaliplatin, 5-fluorouracil/Leucovorin Versus Nab-paclitaxel Plus Gemcitabine in Subjects Who Have Not Previously Received Chemotherapy for Metastatic Adenocarcinoma of the Pancreas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Metastatic Adenocarcinoma of the Pancreas
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2019-09-10
Enrollment: 770
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 look at the efficacy and safety of Irinotecan liposome injection in combination with other approved drugs used for cancer therapy, namely 5 fluorouracil/leucovorin (5FU/LV) plus oxaliplatin compared to nab-paclitaxel + gemcitabine treatment in improving the overall survival of patients not previously treated for metastatic pancreatic cancer.


Eligibility criteria: Inclusion Criteria:

* Histological or cytologically confirmed adenocarcinoma of the pancreas that has not been previously treated in the metastatic setting.
* Initial diagnosis of metastatic disease must have occurred ≤6 weeks prior to screening.
* Subject has one or more metastatic lesions measurable by computed tomography (CT) scan (or magnetic resonance imaging (MRI), if the subject is allergic to CT contrast media) according to RECIST Version 1.1 criteria.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Subject has adequate biological parameters as demonstrated by the following blood counts:(a) Absolute neutrophil count (ANC) ≥2000/mm3 without the use of hemopoietic growth factors within the last 7 days prior to randomisation (b) Platelet count ≥100,000/mm3 (c) Haemoglobin (Hgb) ≥9 g/dL obtained ≤14 days prior to randomisation.
* Adequate hepatic function as evidenced by: (a) Serum total bilirubin ≤1.5x ULN (biliary drainage is allowed for biliary obstruction), and (b) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5x upper limit of normal (ULN) (≤5x ULN is acceptable if liver metastases are present).
* Adequate renal function as evidenced by creatinine clearance ≥30 mL/min.
* Adequate coagulation studies (obtained ≤14 days prior to randomisation) as demonstrated by prothrombin time and partial thromboplastin time within normal limits (≤1.5xULN ).

Exclusion Criteria:

* Prior treatment of pancreatic cancer in the metastatic setting with surgery, radiotherapy, chemotherapy or investigational therapy
* Prior treatment of pancreatic adenocarcinoma with chemotherapy in the adjuvant setting, except those where at least 12 months have elapsed since completion of the last dose and no persistent treatment-related toxicities are present.
* Subject has only localised advanced disease.
* Documented serum albumin \<3 g/dL
* Known history of central nervous system (CNS) metastases.
* Clinically significant gastrointestinal disorder
* History of any second malignancy in the last 2 years
* Concurrent illnesses that would be a relative contraindication to trial participation
* Use of strong inhibitors or inducers of CYP3A, CYP2C8 and UGT1A1
* Neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma
* Known low or absent dihydropyrimidine dehydrogenase (DPD) activity

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Assessments performed at baseline (within 28 days before start of study treatment), every 8 weeks after first dose, end of treatment (EoT) visit, then every 2 months thereafter up to DCO date of 23 July 2022 (maximum of 893 days)
Secondary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: Assessments performed at baseline (within 28 days before start of study treatment), every 8 weeks after first dose until EoT visit (maximum of 893 days)
measure: Overall Response Rate (ORR)
timeFrame: Assessments performed at baseline (within 28 days before start of study treatment), every 8 weeks after first dose until EoT visit, (maximum of 893 days)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Gilbert
country: United States
facility: Banner Health- MD Anderson Cancer Center
state: Arizona
city: Phoenix
country: United States
facility: Mayo Clinic - Scottsdale
state: Arizona
city: Bakersfield
country: United States
facility: Comprehensive Blood And Cancer Center
state: California
city: Costa Mesa
country: United States
facility: University of California- Irvine Health Cancer Cente
state: California
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: Los Angeles
country: United States
facility: University of California, Los Angeles (UCLA)
state: California
city: Orange
country: United States
facility: St. Jude Hospital Yorba Linda dba St. Joseph Heritage Healthcare
state: California
city: Orange
country: United States
facility: University of California - Irvine Medical Center
state: California
city: Redondo Beach
country: United States
facility: Torrance Memorial Physician Network Cancer Care
state: California
city: Sacramento
country: United States
facility: Sutter Health Sacramento
state: California
city: Whittier
country: United States
facility: Presbyterian Intercommunity Hospital (PIH)
state: California
city: Colorado Springs
country: United States
facility: UC Health Memorial Hospital
state: Colorado
city: Denver
country: United States
facility: Rocky Mountain Cancer Center
state: Colorado
city: Miami Beach
country: United States
facility: Mount Sinai Medical Center of Florida, Inc.
state: Florida
city: Miami
country: United States
facility: Miami Cancer Institute
state: Florida
city: Sarasota
country: United States
facility: Florida Cancer Specialists - Fort Myers
state: Florida
city: Tallahassee
country: United States
facility: Florida Cancer Specialists - Panhandle
state: Florida
city: Tampa
country: United States
facility: Florida Cancer Specialists - St. Petersburg
state: Florida
city: West Palm Beach
country: United States
facility: Florida Cancer Specialists - East
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Elmhurst
country: United States
facility: Edward Hospital - Elmhurst
state: Illinois
city: Peoria
country: United States
facility: Illinois CancerCare - Peoria
state: Illinois
city: Urbana
country: United States
facility: Carle Cancer Center
state: Illinois
city: Fort Wayne
country: United States
facility: Fort Wayne Medical Oncology and Hematology
state: Indiana
city: Sioux City
country: United States
facility: Siouxland Hematology - Oncology Associates, LLP
state: Iowa
city: Lexington
country: United States
facility: University of Kentucky Markey Cancer Center
state: Kentucky
city: Pikeville
country: United States
facility: Pikeville Medical Center
state: Kentucky
city: Baton Rouge
country: United States
facility: Hematology Oncology Clinic
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Shreveport
country: United States
facility: Willis-Knighton Cancer Center
state: Louisiana
city: Scarborough
country: United States
facility: Maine Center for Cancer Medicine
state: Maine
city: Silver Spring
country: United States
facility: Maryland Oncology Hematology
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Grand Rapids
country: United States
facility: Cancer and Hematology Centers of Western Michigan
state: Michigan
city: Minneapolis
country: United States
facility: Health Partners Institute
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic - Rochester
state: Minnesota
city: Kansas City
country: United States
facility: Research Medical Center
state: Missouri
city: Billings
country: United States
facility: Frontier Cancer Center
state: Montana
city: Omaha
country: United States
facility: Oncology Hematology West P.C. dba Nebraska Cancer Specialists
state: Nebraska
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Lake Success
country: United States
facility: Clinical Research Alliance, Inc
state: New York
city: New York
country: United States
facility: David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
state: New York
city: Asheville
country: United States
facility: Messino Cancer Center
state: North Carolina
city: Columbus
country: United States
facility: The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solovev Research Institute (OSUCCC - James)
state: Ohio
city: Toledo
country: United States
facility: Toledo Clinic Cancer Center
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma - Health Sciences Center
state: Oklahoma
city: Eugene
country: United States
facility: Oncology Associates of Oregon
state: Oregon
city: Portland
country: United States
facility: Compass Oncology - Rose Quarter Cancer Center
state: Oregon
city: Portland
country: United States
facility: Kaiser Permanente - Northwest
state: Oregon
city: Portland
country: United States
facility: Oregon Health & Science University (OHSU)
state: Oregon
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center
state: Pennsylvania
city: Greenville
country: United States
facility: Greenville Hospital System
state: South Carolina
city: Chattanooga
country: United States
facility: Chattanooga Oncology Hematology Care - Tennessee Oncology
state: Tennessee
city: Memphis
country: United States
facility: The West Cancer Center
state: Tennessee
city: Nashville
country: United States
facility: Sarah Cannon and HCA Research Institute
state: Tennessee
city: Austin
country: United States
facility: Texas Oncology - Austin
state: Texas
city: Dallas
country: United States
facility: Texas Oncology - Baylor Charles A. Sammons Cancer Center
state: Texas
city: Fort Worth
country: United States
facility: The Center for Cancer and Blood Disorders
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: Houston Methodist Research Institute
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Houston
country: United States
facility: Oncology Consultants
state: Texas
city: Tyler
country: United States
facility: Texas Oncology - Tyler
state: Texas
city: Wichita Falls
country: United States
facility: Texas Oncology - Wichita Falls
state: Texas
city: Salt Lake City
country: United States
facility: Utah Cancer Specialists
state: Utah
city: Fairfax
country: United States
facility: Virginia Cancer Specialists
state: Virginia
city: Wytheville
country: United States
facility: Blue Ridge Cancer Care
state: Virginia
city: Milwaukee
country: United States
facility: Froedtert Hospital and the Medical College of Wisconsin
state: Wisconsin
city: Bankstown
country: Australia
facility: Bankstown-Lidcombe Hospital
city: Clayton
country: Australia
facility: Monash Medical Centre
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital
city: Subiaco
country: Australia
facility: St John of God Subiaco Hospital
city: Woodville South
country: Australia
facility: Queen Elizabeth Hospital
city: Graz
country: Austria
facility: Medizinische Universitaet Graz
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH Barmherzige Schwestern
city: Salzburg
country: Austria
facility: SCRI-CCCIT Gemeinnutzige Gmbh- Gemeinnutzige Salzburger Landeskliniken Betriebsgesmbh
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Aalst
country: Belgium
facility: Onze-Lieve-Vrouwziekenhuis
city: Charleroi
country: Belgium
facility: ASBL Grand Hôpital de Charleroi (GHdC), Site Notre Dame
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen (UZA)
city: Gent
country: Belgium
facility: University Hospital Gent
city: Haine-Saint-Paul
country: Belgium
facility: Hospital centre Jolimont
city: Leuven
country: Belgium
facility: University Hospital (UZ) Leuven
city: Yvoir
country: Belgium
facility: University Hospital Mont-Godinne
city: Barretos
country: Brazil
facility: Fundação Pio XII - Hospital de Câncer de Barretos
city: Ceara
country: Brazil
facility: Centro Regional Integrado de Oncologia (CRIO)
city: Curitiba
country: Brazil
facility: Instituto de Oncologia do Parana - IOP
city: Florianópolis
country: Brazil
facility: Centro de Pesquisas Oncológicas - CEPON
city: Ijuí
country: Brazil
facility: Hospital de Caridade de Ijui
city: Itajaí
country: Brazil
facility: Clinica Neoplasias Litoral
city: Lajeado
country: Brazil
facility: Hospital Bruno Born
city: Natal
country: Brazil
facility: Centro de Pesquisas Clinicas de Natal - CPCLIN
city: Porto Alegre
country: Brazil
facility: Irmandade da Santa Casa de Misericordia de Porto Alegre
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional Do Cancer (INCA)
city: Rio De Janeiro
country: Brazil
facility: Instituto COI
city: San Paolo
country: Brazil
facility: Instituto Brasileiro de Controle do Cancer - IBCC (Sao Paulo)
city: São José Do Rio Preto
country: Brazil
facility: CIP Centro Integrado de Pesquisas do Hospital de Base
city: São Paulo
country: Brazil
facility: Hospital Alemão Oswaldo Cruz
city: São Paulo
country: Brazil
facility: Instituto do Cancer do Estado de São Paulo (ICESP)
city: Edmonton
country: Canada
facility: Alberta Health Services Cross Cancer Institute
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre
city: Montréal
country: Canada
facility: McGill University Faculty of Medicine - Royal Victoria Hospital
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke
city: Brno
country: Czechia
facility: Masarykuv onkologicky ustav
city: Hradec Králové
country: Czechia
facility: Fakultni nemocnice Hradec Kralove
city: Olomouc
country: Czechia
facility: University Hospital Olomouc, Department of Oncology
city: Praha
country: Czechia
facility: Thomayerova Nemocnice
city: Chambray-lès-Tours
country: France
facility: CHRU de Tours - Hôpital Trousseau
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lyon
country: France
facility: Hôpital Edouard Herriot
city: Lyon
country: France
facility: Centre Leon Berard
city: Lyon
country: France
facility: Hopital Prive Jean Mermoz
city: Nice
country: France
facility: Centre Antoine-Lacassagne
city: Paris
country: France
facility: Hopital Saint Louis
city: Pessac
country: France
facility: CHU Bordeaux - Hopital Haut-Leveque
city: Poitiers Cedex
country: France
facility: Centre Hospitalier Universitaire de Poitiers - Poitiers University Hospital
city: Strasbourg
country: France
facility: Strasbourg Oncologie Liberale
city: Berlin
country: Germany
facility: Charité - Universitaetsmedizin Berlin
city: Bochum
country: Germany
facility: St. Josef-Hospital
city: Esslingen
country: Germany
facility: Klinikum Esslingen GmbH
city: Frankfurt
country: Germany
facility: Krankenhaus Nordwest
city: Halle
country: Germany
facility: Studiengesellschaft BSF
city: Halle
country: Germany
facility: Martin Luther Universitat Halle-Wittenberg
city: Hamburg
country: Germany
facility: Facharztzentrum Eppendorf
city: Hamburg
country: Germany
facility: Marienkrankenhaus Hamburg
city: Hamburg
country: Germany
facility: Asklepios Klinik Altona
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Heilbronn
country: Germany
facility: Slk-Kliniken
city: Mannheim
country: Germany
facility: Klinikum Mannheim
city: Mönchengladbach
country: Germany
facility: Krankenhaus St. Franziskus - Kliniken Maria Hilf GmbH
city: Tuebingen
country: Germany
facility: Universitaetsklinikum Tuebingen
city: Ulm
country: Germany
facility: Universitaetsklinikum Ulm
city: Athens
country: Greece
facility: Agios Savvas Anticancer Hospital
city: Athens
country: Greece
facility: General Hospital of Athens - Laiko
city: Athens
country: Greece
facility: National and Kapodistrian University of Athens
city: Ioánnina
country: Greece
facility: University General Hospital of Ioannina
city: Thessaloníki
country: Greece
facility: Theagenion Hospital
city: Budapest
country: Hungary
facility: Dél-pesti Centrumkórház - Szent László Kórház telephely
city: Budapest
country: Hungary
facility: Országos Onkológiai Intézet
city: Budapest
country: Hungary
facility: Semmelweis Egyetem Belgyógyászati és Hematológiai Klinika
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Kaposvár
country: Hungary
facility: Somogy Megyei Kaposi Mor Oktato Korhaz
city: Szolnok
country: Hungary
facility: Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Rendelointézet
city: Beer Sheva
country: Israel
facility: Soroka Medical Center
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Bologna
country: Italy
facility: Policlinico S. Orsola-Malpighi
city: Meldola
country: Italy
facility: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia
city: Modena
country: Italy
facility: Azienda Ospedaliero-Universitaria di Modena
city: Piacenza
country: Italy
facility: AUSL di Piacenza-Ospedale Guglielmo Da Saliceto
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
city: Torrette
country: Italy
facility: AOU Ospedali Riuniti di Ancona
city: Verona
country: Italy
facility: Azienda Ospedaliera - Universitaria Integrata di Verona - Ospedale Borgo Roma
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
city: Gyeonggi-do
country: Korea, Republic of
facility: CHA Bundang Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital, The Catholic University of Korea
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Braga
country: Portugal
facility: Hospital de Braga
city: Lisboa
country: Portugal
facility: Centro Hospitalar Universitario de Lisboa Norte - Hospital de Santa Maria
city: Lisbon
country: Portugal
facility: Champalimaud Cancer Center
city: Senhora da Hora
country: Portugal
facility: Unidade Local de Saude Matosinhos E.P.E. Hospital Pedro Hispano
city: Vila Nova de Gaia
country: Portugal
facility: Centro Hospitalar de Vila Nova de Gaia/Espinho EPE
city: Chelyabinsk
country: Russian Federation
facility: Evimed LLC
city: Kazan
country: Russian Federation
facility: Limited Liability Company- Clinica Druzhkovyh
city: Kursk
country: Russian Federation
facility: Kursk Regional Clinical Oncology Dispensary
city: Moscow
country: Russian Federation
facility: Main Military Clinical Hospital named after N.N. Burdenko
city: Novgorod
country: Russian Federation
facility: Volga District Medical Centre
city: Saint-Petersburg
country: Russian Federation
facility: Federal State Budgetary Institution - Russian Scientific Center of Radiology and Surgical Technologies n.a. academician A.M.Granov
city: Alicante
country: Spain
facility: Hospital General Universitario de Elche
city: Badajoz
country: Spain
facility: Hospital Universitario de Badajoz
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Hospital Quironsalud Barcelona
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau Barcelona
city: Barcelona
country: Spain
facility: Hospital Vall D Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic Barcelona
city: Barcelona
country: Spain
facility: Corporacio Sanitaria Parc Tauli - Hospital de Sabadell
city: Barcelona
country: Spain
facility: Institut Catala d'Oncologia - L'Hospitalet
city: Granada
country: Spain
facility: Complejo Hospitalario Universitario de Granada - Hospital Universitario Virgen de las Nieves
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
city: Madrid
country: Spain
facility: Fundacion Jimenez Diaz
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Centro Integral Oncologico Clara Campal
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Malaga
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: London
country: United Kingdom
facility: Guy's and St. Thomas' NHS Foundation Trust
city: London
country: United Kingdom
facility: Royal Marsden Foundation Trust
city: London
country: United Kingdom
facility: Royal Marsden Foundation Trust
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
city: Manchester
country: United Kingdom
facility: Cancer Research UK - Christie Hospital Foundation NHS Trust - Dept of Medical Oncology
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: