NAPOLI III - Irinotecan Liposome injection in Pancreatic Cancer

• Research type

  Research Study

• Full 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.

• IRAS ID

  274214

• Contact name

  Richard Hubner

• Contact email

  richard.hubner@christie.nhs.uk

• Sponsor organisation

  Ipsen Bioscience Inc.

• Eudract number

  2018-003585-14

• Clinicaltrials.gov Identifier

  NCT04083235

• Duration of Study in the UK

  2 years, 6 months, 3 days

• Research summary

  This is an open-label, randomized, phase III study to evaluate the efficacy and safety of the irinotecan liposome injection + oxaliplatin + 5-FU/LV combination compared to nab-paclitaxel + gemcitabine as first-line treatment in adult patients with metastatic pancreatic cancer. The researchers and patients will know which treatment the patient will be receiving.
  
  Patients will be randomized on a 1:1 ratio (there’s a 50% chance of receiving either) to one of the following treatment regimens:

  • Arm 1: irinotecan liposome injection + oxalaplatin + 5-FU/LV
  • Arm 2: nab-paclitaxel + gemcitabine

  Approximately 750 patients will be recruited at approximately 200-220 clinical sites across North America, South America, Europe and Australia. The study will consist of:

  • A screening period of 28 days
  • A treatment phase 28 day cycles until disease progression
  • A follow up phase until the end of the study

  There is no pre-determined duration for patients receiving treatment on either arm, it is intended that patients will be treated until disease progression, withdrawal from the study or unacceptable levels of toxicity related to the study medication.
  Patients will undergo safety and tolerability assessments throughout the study that include but not limited to: physical examination, blood draws, CT Scans and questionnaires.

• REC name

  East Midlands - Leicester South Research Ethics Committee

• REC reference

  20/EM/0087

• Date of REC Opinion

  7 May 2020

• REC opinion

  Further Information Favourable Opinion