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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT04083235

Public ClinicalTrials.gov record NCT04083235. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 13, 2026, 5:02 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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 identification

NCT ID
NCT04083235
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Ipsen
Industry
Enrollment
770 participants

Conditions and interventions

Interventions

  • 5Fluorouracil Drug
  • Gemcitabine Drug
  • Irinotecan Liposomal Injection Drug
  • Leucovorin Drug
  • Nab-paclitaxel Drug
  • Oxaliplatin Drug

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 10, 2020
Primary completion
Jul 22, 2022
Completion
Feb 17, 2025
Last update posted
Apr 19, 2026

2020 – 2025

United States locations

U.S. sites
72
U.S. states
31
U.S. cities
66
Facility City State ZIP Site status
University of Alabama at Birmingham Birmingham Alabama 35294
Banner Health- MD Anderson Cancer Center Gilbert Arizona 85234
Mayo Clinic - Scottsdale Phoenix Arizona 85054
Comprehensive Blood And Cancer Center Bakersfield California 93309
University of California- Irvine Health Cancer Cente Costa Mesa California 92627
City of Hope National Medical Center Duarte California 91010
University of California, Los Angeles (UCLA) Los Angeles California 90095
St. Jude Hospital Yorba Linda dba St. Joseph Heritage Healthcare Orange California 92835
University of California - Irvine Medical Center Orange California 92868
Torrance Memorial Physician Network Cancer Care Redondo Beach California 90277
Sutter Health Sacramento Sacramento California 95816
Presbyterian Intercommunity Hospital (PIH) Whittier California 90602
UC Health Memorial Hospital Colorado Springs Colorado 80909
Rocky Mountain Cancer Center Denver Colorado 80218
Miami Cancer Institute Miami Florida 33176
Mount Sinai Medical Center of Florida, Inc. Miami Beach Florida 33140
Florida Cancer Specialists - Fort Myers Sarasota Florida 34236
Florida Cancer Specialists - Panhandle Tallahassee Florida 32308
Florida Cancer Specialists - St. Petersburg Tampa Florida 33607
Florida Cancer Specialists - East West Palm Beach Florida 33401
Rush University Medical Center Chicago Illinois 60612
Edward Hospital - Elmhurst Elmhurst Illinois 60540
Illinois CancerCare - Peoria Peoria Illinois 61443
Carle Cancer Center Urbana Illinois 61801
Fort Wayne Medical Oncology and Hematology Fort Wayne Indiana 46804
Siouxland Hematology - Oncology Associates, LLP Sioux City Iowa 51101
University of Kentucky Markey Cancer Center Lexington Kentucky 40536
Pikeville Medical Center Pikeville Kentucky 41501
Hematology Oncology Clinic Baton Rouge Louisiana 70809
Ochsner Clinic Foundation New Orleans Louisiana 70121
Willis-Knighton Cancer Center Shreveport Louisiana 71103
Maine Center for Cancer Medicine Scarborough Maine 04074
Maryland Oncology Hematology Silver Spring Maryland 20904
Beth Israel Deaconess Boston Massachusetts 02215
Henry Ford Health System Detroit Michigan 48202
Cancer and Hematology Centers of Western Michigan Grand Rapids Michigan 49546
Health Partners Institute Minneapolis Minnesota 55425
Mayo Clinic - Rochester Rochester Minnesota 55902
Research Medical Center Kansas City Missouri 64132
Frontier Cancer Center Billings Montana 59102
Oncology Hematology West P.C. dba Nebraska Cancer Specialists Omaha Nebraska 68130
Comprehensive Cancer Centers of Nevada Las Vegas Nevada 89169
Clinical Research Alliance, Inc Lake Success New York 10021
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center New York New York 10065
University of Rochester Rochester New York 14642
Stony Brook University Medical Center Stony Brook New York 11794
Messino Cancer Center Asheville North Carolina 28806
The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solovev Research Institute (OSUCCC - James) Columbus Ohio 43210
Toledo Clinic Cancer Center Toledo Ohio 43623
University of Oklahoma - Health Sciences Center Oklahoma City Oklahoma 73104
Oncology Associates of Oregon Eugene Oregon 97401
Compass Oncology - Rose Quarter Cancer Center Portland Oregon 97227
Kaiser Permanente - Northwest Portland Oregon 97227
Oregon Health & Science University (OHSU) Portland Oregon 97239
University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center Pittsburgh Pennsylvania 15232
Greenville Hospital System Greenville South Carolina 29605
Chattanooga Oncology Hematology Care - Tennessee Oncology Chattanooga Tennessee 37404
The West Cancer Center Memphis Tennessee 38138
Sarah Cannon and HCA Research Institute Nashville Tennessee 37203
Texas Oncology - Austin Austin Texas 78731
Texas Oncology - Baylor Charles A. Sammons Cancer Center Dallas Texas 75246
The Center for Cancer and Blood Disorders Fort Worth Texas 76104
Baylor College of Medicine Houston Texas 77030
Houston Methodist Research Institute Houston Texas 77030
MD Anderson Cancer Center Houston Texas 77030
Oncology Consultants Houston Texas 77030
Texas Oncology - Tyler Tyler Texas 75702
Texas Oncology - Wichita Falls Wichita Falls Texas 76310
Utah Cancer Specialists Salt Lake City Utah 84106
Virginia Cancer Specialists Fairfax Virginia 22031
Blue Ridge Cancer Care Wytheville Virginia 24014
Froedtert Hospital and the Medical College of Wisconsin Milwaukee Wisconsin 53226

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 128 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04083235, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 19, 2026 · Synced May 13, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04083235 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →