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
Completed · Phase 3 · NCT04083235
Conditions: Metastatic Adenocarcinoma of the Pancreas
At a glance
- Research payments reported, 2025
- $683,114
- U.S. investigators named
- 46
- Sites paid
- 32
- Planned or actual enrollment
- 770
About the trial
- Sponsor
- Ipsen
- Tested
- Irinotecan Liposomal Injection (drug), Oxaliplatin (drug), 5Fluorouracil (drug), Leucovorin (drug), Nab-paclitaxel (drug), Gemcitabine (drug)
- Dates
- Started 2020-02-11; completion 2025-02-18
- Results posted
- Yes
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.
From ClinicalTrials.gov, last updated 2026-04-20. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Ipsen Bioscience Inc. reported $683,114 in research payments for this study in 2025 (95 payments).
Products named: Onivyde
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Daniel M. Schreeder, MD, PHD Hematology & Oncology · Huntsville, AL
- Grant R. Williams, MD Hematology & Oncology · Birmingham, AL
- Tanios S. Bekaii-saab, M.D. Hematology & Oncology · Scottsdale, AZ
- Vincent Chung, MD Medical Oncology · Duarte, CA
- Farshid Dayyani, M.D., PH.D. Medical Oncology · Orange, CA
- David J. Park, M.D. Medical Oncology · Fullerton, CA
- Zev A. Wainberg, MD Hematology & Oncology · Santa Monica, CA
- Allen L. Cohn, MD Hematology & Oncology · Denver, CO
- Pablo Ferraro, MD Hematology & Oncology · Pembroke Pines, FL
- Anjan J. Patel, M.D. Medical Oncology · Sarasota, FL
- Donald B. Wender, M.D. Hematology & Oncology · Sioux City, IA
- Alexander Hantel, MD Hematology & Oncology · Naperville, IL
- Sunil Babu, M.D. Medical Oncology · Fort Wayne, IN
- Reema A. Patel, M.D. Medical Oncology · Lexington, KY
- Michael J. Castine III, MD Medical Oncology · Baton Rouge, LA
- Suma P. Satti, M.D. Hematology · New Orleans, LA
- Anil Veluvolu, MD Hematology & Oncology · Shreveport, LA
- Andrea J. Bullock, M.D. Internal Medicine · Boston, MA
- Kashif Ali, M.D. Hematology & Oncology · Silver Spring, MD
- Sreenivasa Chandana, MD Hematology & Oncology · Grand Rapids, MI
- Gazala N. Khan, M.D. Internal Medicine · Ann Arbor, MI
- Daniel M. Anderson, MD Hematology & Oncology · Saint Paul, MN
- Deepti Behl, M.D. Hematology & Oncology · Rochester, MN
- Patrick W. Cobb, M.D. Hematology & Oncology · Billings, MT
- Christopher H. Chay, M.D. Hematology & Oncology · Asheville, NC
- Nagendra Natarajan, MD.,MPH Hematology & Oncology · Omaha, NE
- Brian D. Vicuna, MD Medical Oncology · Las Vegas, NV
- Aram F. Hezel, MD Hematology & Oncology · Rochester, NY
- Amna F. Sher, MD Medical Oncology · Stony Brook, NY
- Alice A. Zervoudakis, M.D. Medical Oncology · West Harrison, NY
- Anne M. Noonan, MD Hematology & Oncology · Columbus, OH
- Hassan Hatoum, MD Hematology & Oncology · Oklahoma City, OK
- Pradip K. Rustagi, MD Hematology & Oncology · Bend, OR
- Spencer H. Shao, M.D. Medical Oncology · Portland, OR
- Marc Uemura, M.D. Internal Medicine · Eugene, OR
- David R. Spigel, M.D. Medical Oncology · Nashville, TN
- Mark S. Womack IV, M.D. Hematology & Oncology · Chattanooga, TN
- Tannaz Armaghany, M.D. Hematology & Oncology · Houston, TX
- Vivian Cline, MD Medical Oncology · Round Rock, TX
- Andrew S. Paulson, MD Medical Oncology · Dallas, TX
- Julio A. Peguero, M.D Medical Oncology · Corpus Christi, TX
- Brian K. Ulrich, M.D. Medical Oncology · Wichita Falls, TX
- Henry Q. Xiong, M.D. Hematology & Oncology · Fort Worth, TX
- Stephan D. Kendall, M.D. Medical Oncology · Salt Lake City, UT
- Mark D. Kochenderfer, MD Hematology & Oncology · Roanoke, VA
- Keeran R. Sampat, MD Hematology & Oncology · Arlington, VA
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- City of Hope National Medical Ctr $91,708
- Ronald Reagan UCLA Medical Center, CA $81,456
- Translational Oncology Research Intl $67,298
- Nebraska Cancer Specialists $45,843
- Cancer and Hematology Centers of Western Michigan, PC $43,947
- Sarah Cannon Cancer Institute at Hdh $37,238
- Uci Health Chao Family Comprehensive Cancer Center $35,261
- Memorial Sloan Kettering $34,348
- Stony Brook Surgical Associates $26,577
- US Oncology Research LLC $26,549
- Oncology Consultants, PA $23,438
- University of Rochester Medical Center School of Medicine and Dentistry $21,158
- Beth Israel Deaconess Medical Center, MA $19,081
- Mayo Clinic $16,643
- Ohio State University Research Compliance $13,493
- Utah Cancer Specialists $12,083
- Ochsner Medical Center Acute, LA $11,349
- Ky Medical Services Foundation $9,949
- Wk Physicians Network $9,799
- Oncology Hematology Consultants, PA $9,720
- Intermountain Health St Vincent Regional Hospital, MT $8,250
- University of Alabama Hospital, AL $7,925
- Baylor College of Medicine $7,800
- Board of Regents of the University of Oklahoma Health Sciences Center $7,346
- Virginia Cancer Specialists $4,000
- Siouxland Regional Cancer Center $2,100
- Oncology Specialties PC $2,000
- Linden Oaks Behavioral Health $1,750
- Henry Ford Health Hospital, MI $1,567
- Sutter Amador Hospital, CA $1,438
- Comprehensive Cancer Centers of Nevada $1,050
- Health PArtners $950
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.