Chemotherapy Combination for Pancreatic Cancer
(NAPOLI 3 Trial)
Trial Summary
What is the purpose of this trial?
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.
Research Team
Ipsen Medical Director
Principal Investigator
Ipsen
Eligibility Criteria
This trial is for adults with a recent diagnosis of metastatic pancreatic cancer who haven't been treated for it before. They should have measurable tumors, be in good physical condition (ECOG 0 or 1), and have normal blood counts, liver and kidney function. People can't join if they've had only localized disease, certain other cancers within the last two years, or used strong drug inhibitors/inducers recently.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Irinotecan liposome injection with 5-FU/LV and oxaliplatin or nab-paclitaxel with gemcitabine in 28-day cycles until progression or unacceptable toxicity
Follow-up
Participants are monitored for overall survival and progression-free survival every 8 weeks after the first dose, and every 2 months after the end of treatment
Treatment Details
Interventions
- 5Fluorouracil
- Gemcitabine
- Irinotecan Liposomal Injection
- Leucovorin
- Nab-paclitaxel
- Oxaliplatin
5Fluorouracil is already approved in United States, Canada, European Union for the following indications:
- Actinic keratosis
- Basal cell carcinoma
- Actinic keratosis
- Basal cell carcinoma
- Anal Cancer
- Breast Cancer
- Cervical Cancer
- Colorectal Cancer
- Nasopharyngeal Carcinoma
- Pancreatic Cancer
- Stomach Cancer
- Actinic keratosis
- Basal cell carcinoma
- Anal Cancer
- Breast Cancer
- Cervical Cancer
- Colorectal Cancer
- Nasopharyngeal Carcinoma
- Pancreatic Cancer
- Stomach Cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ipsen
Lead Sponsor
David Loew
Ipsen
Chief Executive Officer since 2020
BA in Business Administration and MBA from the University of St. Gallen, Switzerland
Sandra Silvestri
Ipsen
Chief Medical Officer since 2023
MD, PhD