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

Conditions studied: Metastatic Adenocarcinoma of the Pancreas

In brief

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.

Key facts

Study ID

NCT04083235

Run by

Ipsen

People needed

770

Starts

2020-02-11

Expected to finish

2025-02-18

Last updated by the study team

2026-04-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 ).

You may not qualify if…

• 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

Where it is running

• Banner Health- MD Anderson Cancer Center — Gilbert, Arizona, United States
• Mayo Clinic - Scottsdale — Phoenix, Arizona, United States
• Comprehensive Blood And Cancer Center — Bakersfield, California, United States
• University of California- Irvine Health Cancer Cente — Costa Mesa, California, United States
• City of Hope National Medical Center — Duarte, California, United States
• University of California, Los Angeles (UCLA) — Los Angeles, California, United States
• St. Jude Hospital Yorba Linda dba St. Joseph Heritage Healthcare — Orange, California, United States
• University of California - Irvine Medical Center — Orange, California, United States
• Torrance Memorial Physician Network Cancer Care — Redondo Beach, California, United States
• Sutter Health Sacramento — Sacramento, California, United States
• Presbyterian Intercommunity Hospital (PIH) — Whittier, California, United States
• UC Health Memorial Hospital — Colorado Springs, Colorado, United States
• Rocky Mountain Cancer Center — Denver, Colorado, United States
• Miami Cancer Institute — Miami, Florida, United States
• Mount Sinai Medical Center of Florida, Inc. — Miami Beach, Florida, United States
• Florida Cancer Specialists - Fort Myers — Sarasota, Florida, United States
• Florida Cancer Specialists - Panhandle — Tallahassee, Florida, United States
• Florida Cancer Specialists - St. Petersburg — Tampa, Florida, United States
• Florida Cancer Specialists - East — West Palm Beach, Florida, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Edward Hospital - Elmhurst — Elmhurst, Illinois, United States
• Illinois CancerCare - Peoria — Peoria, Illinois, United States
• Carle Cancer Center — Urbana, Illinois, United States
• Fort Wayne Medical Oncology and Hematology — Fort Wayne, Indiana, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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