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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 belowSelect...
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.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
NAPOLI 3 Trial 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 until eot visit (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 until eot visit (maximum of 893 days)
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
345 Previous Clinical Trials
72,458 Total Patients Enrolled
Ipsen Medical DirectorStudy DirectorIpsen
257 Previous Clinical Trials
54,375 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have at least one cancer spot that can be measured on a scan.My kidneys work well enough, with a creatinine clearance rate of at least 30 mL/min.My body has low or no DPD enzyme activity.I have a history of cancer spreading to my brain or spinal cord.My pancreatic cancer is confirmed and untreated in its advanced stage.My cancer is a type of pancreatic or neuroendocrine tumor.I had chemotherapy for pancreatic cancer over a year ago with no lasting side effects.I have a serious stomach or intestine problem.My liver is functioning well according to recent blood tests.I have not had any other type of cancer in the past 2 years.My cancer has not spread beyond its original area.I am not taking medication that strongly affects certain liver enzymes.My metastatic disease was diagnosed less than 6 weeks ago.I am fully active or restricted in physically strenuous activity but can do light work.I have had treatment for pancreatic cancer after it spread, including surgery, radiation, or chemotherapy.
Research Study Groups:
This trial has the following groups:- Group 1: Nab-paclitaxel + Gemcitabine
- Group 2: Irinotecan liposome injection + Oxaliplatin + 5-FU/LV
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Pancreatic Cancer Patient Testimony for trial: Trial Name: NCT04083235 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
At how many hospitals or other medical facilities is this clinical trial taking place?
"University of South Alabama - Division of Clinical Research in Mobile, Alabama, University of Calfornia- Irvine Health Cancer Cente in Costa Mesa, California, and Memorial Cancer Institute in Hollywood, Florida are some of the 100 locations running this trial."
Answered by AI
Has the FDA okayed Irinotecan Liposomal Injection for patient use?
"There is some evidence of efficacy and extensive data supporting safety, so our team at Power estimated the safety of Irinotecan Liposomal Injection to be a 3."
Answered by AI
How many people total are allowed to participate in this clinical trial?
"As of now, this clinical trial is no longer recruiting patients. The trial was originally posted on February 19th, 2020 and was last updated on October 26th, 2020. If you are looking for other studies, there are presently 781 studies actively admitting participants with pancreas and 1702 trials for Irinotecan Liposomal Injection actively searching for patients."
Answered by AI
Are volunteers still being recruited for this research?
"This study is no longer enrolling patients. Recruitment for this trial ended on October 26th, 2020. 781 other clinical trials are currently enrolling patients for pancreas-related studies and 1702 studies are enrolling patients for Irinotecan Liposomal Injection."
Answered by AI
Do we have any historical precedent for Irinotecan Liposomal Injection?
"There are currently 1702 active medical trials researching Irinotecan Liposomal Injection, with 495 of those in Phase 3. Most of the clinical trials for Irinotecan Liposomal Injection are located in Guangzhou, Guangdong, but there are 82684 total locations conducting research on this medication."
Answered by AI
What are the conditions that Irinotecan Liposomal Injection is used to treat?
"Carcinomas like non-small cell lung cancer, malignant neoplasms, and rectal carcinoma can all be treated with Irinotecan Liposomal Injection."
Answered by AI
Who else is applying?
What state do they live in?
Louisiana
What site did they apply to?
Hematology Oncology Clinic
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I'm just starting this journey and want to be involved with any treatment that could extend my life.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
What is the estimated time to begin?
PatientReceived 1 prior treatment
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