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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 (NAPOLI 3)

Protocol No
IPSEN-D-US-60010-001-NAPOLI-3
Principal Investigator
Mandana Kamgar
Phase
III
Summary
The purpose of this study is to look at how safe and helpful the study drug, Irinotecan Liposome injection, is when given together with the approved cancer drugs 5-Fluorouracil/Leucovorin (5- FU/LV) plus Oxaliplatin in patients not previously treated for metastatic pancreatic cancer, compared to the approved cancer drugs Nab-Paclitaxel plus Gemcitabine. To determine how helpful the treatments are, your tumor will be measured by scans (CT scans or MRI) and you will be followed for any further treatments you receive for your cancer and followed for your health status. Irinotecan Liposome injection is approved in combination with 5-FU/LV for the treatment of pancreatic cancer after failure of initial therapy with Gemcitabine in the United States, European Union (Including Norway, Iceland and Liechtenstein), Australia, Canada, Switzerland, South Korea, Colombia, Singapore, New Zealand, Taiwan, and Japan. The active ingredient is Irinotecan, a chemotherapy agent which has proven anti-cancer activity. Irinotecan Liposome injection is not as yet approved by the FDA as the initial treatment of metastatic pancreatic cancer in combination with the other drugs as it will be studied in this trial. Therefore, it is considered investigational in this study. We don’t know if this study will help you. Your condition may get better, but it could stay the same or even get worse. We hope the information from this study will help us develop a better treatment for pancreatic cancer in the future.
Description
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.
Participating Institutions
Froedtert Hospital
Status
OPEN TO ACCRUAL