for people ages 18 years and up (full criteria)
at Costa Mesa, California and other locations
study started
completion around



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.

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


Metastatic Adenocarcinoma of the Pancreas, Adenocarcinoma, Leucovorin, Paclitaxel, Gemcitabine, Oxaliplatin, Fluorouracil, Irinotecan, Irinotecan Liposomal Injection, 5Fluorouracil, Nab-paclitaxel, Irinotecan liposome injection + Oxaliplatin + 5-FU/LV, Nab-paclitaxel + Gemcitabine


You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join 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


  • University of California- Irvine Health Cancer Cente
    Costa Mesa California 92627 United States
  • University of California - Irvine Medical Center
    Orange California 92868 United States
  • St. Jude Hospital Yorba Linda dba St. Joseph Heritage Healthcare
    Orange California 92835 United States
  • Presbyterian Intercommunity Hospital (PIH)
    Whittier California 90602 United States
  • University of California, Los Angeles (UCLA)
    Los Angeles California 90095 United States


in progress, not accepting new patients
Start Date
Completion Date
Phase 3 Pancreatic Cancer Research Study
Study Type
About 770 people participating
Last Updated