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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

Must not have

Known low or absent dihydropyrimidine dehydrogenase (DPD) activity

Known history of central nervous system (CNS) metastases

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

No Placebo-Only Group

Pivotal 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.

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.

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.

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.

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My body has low or no DPD enzyme activity.

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I have a history of cancer spreading to my brain or spinal cord.

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My cancer is a type of pancreatic or neuroendocrine tumor.

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I have a serious stomach or intestine problem.

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I have not had any other type of cancer in the past 2 years.

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My cancer has not spread beyond its original area.

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I am not taking medication that strongly affects certain liver enzymes.

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I have had treatment for pancreatic cancer after it spread, including surgery, radiation, or chemotherapy.

Timeline

Screening ~ 3 weeks3 visits

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)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Survival (OS)

Secondary study objectives

Overall Response Rate (ORR)

Progression Free Survival (PFS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

~6010

5Fluorouracil

2020