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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    750
  • sponsor
    Ipsen
Updated on 28 July 2021

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.

Details
Condition Metastatic Adenocarcinoma of the Pancreas
Treatment Gemcitabine, Oxaliplatin, Nab-paclitaxel, Leucovorin, 5Fluorouracil, Irinotecan Liposomal Injection
Clinical Study IdentifierNCT04083235
SponsorIpsen
Last Modified on28 July 2021

Eligibility

Yes No Not Sure

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 tumours 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
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