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Anti-metabolite

Chemotherapy Combination for Pancreatic Cancer (NAPOLI 3 Trial)

Phase 3
Waitlist Available
Research Sponsored by Ipsen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adequate renal function as evidenced by creatinine clearance ≥30 mL/min
Histological or cytologically confirmed adenocarcinoma of the pancreas that has not been previously treated in the metastatic setting
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessments performed at baseline (within 28 days before start of study treatment), every 8 weeks after first dose until eot visit, (maximum of 893 days)
Awards & highlights

NAPOLI 3 Trial Summary

This trial is testing a new cancer drug combination to see if it can improve overall survival in patients with metastatic pancreatic cancer.

Who is the study for?
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.Check my eligibility
What is being tested?
The study tests Irinotecan liposome injection combined with 5-fluorouracil/Leucovorin and Oxaliplatin against Nab-paclitaxel plus Gemcitabine treatment to see which is better at improving survival rates in patients with untreated metastatic pancreatic cancer.See study design
What are the potential side effects?
Possible side effects include nausea, vomiting, diarrhea, fatigue, decreased appetite, hair loss from Nab-paclitaxel/Gemcitabine; and similar effects from Irinotecan liposome injection combo may also cause mouth sores and increased risk of infection.

NAPOLI 3 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidneys work well enough, with a creatinine clearance rate of at least 30 mL/min.
Select...
My pancreatic cancer is confirmed and untreated in its advanced stage.
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I am fully active or restricted in physically strenuous activity but can do light work.

NAPOLI 3 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessments performed at baseline (within 28 days before start of study treatment), every 8 weeks after first dose, end of treatment (eot) visit, then every 2 months thereafter up to dco date of 23 july 2022 (maximum of 893 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessments performed at baseline (within 28 days before start of study treatment), every 8 weeks after first dose, end of treatment (eot) visit, then every 2 months thereafter up to dco date of 23 july 2022 (maximum of 893 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Survival (OS)
Secondary outcome measures
Overall Response Rate (ORR)
Progression Free Survival (PFS)

NAPOLI 3 Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Irinotecan liposome injection + Oxaliplatin + 5-FU/LVExperimental Treatment4 Interventions
Irinotecan liposome injection, oxaliplatin, 5 FU/LV, will be administered on Days 1 and 15 of each 28-day cycle (until progression or unacceptable toxicity).
Group II: Nab-paclitaxel + GemcitabineActive Control2 Interventions
Nab-paclitaxel and gemcitabine will be administered on Days 1, 8 and 15 of each 28-day cycle (until progression or unacceptable toxicity).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Leucovorin
2005
Completed Phase 4
~5730
5Fluorouracil
2020
Completed Phase 3
~900
Oxaliplatin
2011
Completed Phase 4
~2560

Find a Location

Who is running the clinical trial?

IpsenLead Sponsor
346 Previous Clinical Trials
72,505 Total Patients Enrolled
Ipsen Medical DirectorStudy DirectorIpsen
258 Previous Clinical Trials
54,524 Total Patients Enrolled

Media Library

5Fluorouracil (Anti-metabolite) Clinical Trial Eligibility Overview. Trial Name: NCT04083235 — Phase 3
Pancreatic Cancer Research Study Groups: Nab-paclitaxel + Gemcitabine, Irinotecan liposome injection + Oxaliplatin + 5-FU/LV
Pancreatic Cancer Clinical Trial 2023: 5Fluorouracil Highlights & Side Effects. Trial Name: NCT04083235 — Phase 3
5Fluorouracil (Anti-metabolite) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04083235 — Phase 3
Pancreatic Cancer Patient Testimony for trial: Trial Name: NCT04083235 — Phase 3
~147 spots leftby Jun 2025
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