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Welcome to NAPOLI 3

About NAPOLI 3 Eligibility Checker

About NAPOLI 3

NAPOLI 3 is an open-label, randomized, multicenter, phase III study. The study is being conducted by Ipsen Bioscience.

Patients will be randomized in a 1:1 ratio to one of the following treatment arms:

Arm 1

Irinotecan liposome injection + oxaliplatin + 5-FU/LV

Arm 2

Nab-paclitaxel + gemcitabine

There is no pre-defined duration of treatment for each patient. It is intended that patients will be treated in 28-day cycles until radiologically determined progressive disease per RECIST v1.1, unacceptable study-medication-related toxicity, or withdrawal from the study.

Approximately 750 patients will be randomized with approximately 375 patients participating in each arm.

Primary Efficacy Endpoint

The primary efficacy endpoint is the overall survival of patients treated with irinotecan liposome injection + oxaliplatin + 5-FU/LV compared to patients treated with nab-paclitaxel + gemcitabine.

Secondary Efficacy Endpoint

The secondary efficacy endpoints, progression-free survival and overall response rate, will only be evaluated if the primary efficacy endpoint demonstrates superiority for irinotecan liposome injection + oxaliplatin + 5-FU/LV over nab-paclitaxel + gemcitabine. Investigator-assessed tumor response will be used in efficacy analysis.

Learn more about NAPOLI 3 (study identifier: NCT04083235) at ClinicalTrials.gov.

Eligibility Checker

90 – 100 sites in the US

Eligibility Criteria

There are a number of key eligibility criteria in the NAPOLI 3 study that you should be aware of.

Key Inclusion Criteria
  • Histologically or cytologically confirmed adenocarcinoma of the pancreas that has not been previously treated in the metastatic setting
  • Initial diagnosis of metastatic disease must have occurred ≤ 6 weeks prior to screening
  • Patient has one or more metastatic tumors measurable by CT scan or MRI (if the patient is allergic to CT contrast media) according to RECIST v1.1
  • ECOG performance status of 0 or 1
  • Patient has adequate biological parameters, hepatic function, renal function, and coagulation studies
Key Exclusion Criteria
  • Prior treatment of pancreatic cancer in the metastatic setting with surgery, radiotherapy, chemotherapy, or investigational therapy except palliative radiotherapy and biliary stent/tube
  • Prior treatment of pancreatic adenocarcinoma with chemotherapy in the adjuvant setting, except those where at least 12 months have elapsed since completion of the last dose and no persistent treatment-related toxicities are present
  • Patient has only localized advanced disease
  • Documented serum albumin < 3 g/dL
  • Known history of CNS metastases
  • Clinically significant gastrointestinal disorder
  • History of any second malignancy in the last 2 years
  • Concurrent illnesses that would be a relative contraindication to study participation such as active cardiac or liver disease
  • Use of strong inhibitors or inducers of CYP3A, CYP2C8, and UGT1A1
  • Neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma

Irinotecan Liposome Injection

Irinotecan liposome injection is indicated, in combination with 5-FU/LV, for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy. Irinotecan liposome injection is currently under investigation in patients who have not previously received chemotherapy for metastatic pancreatic adenocarcinoma. Please note that irinotecan liposome injection is not currently approved as a first-line treatment for the disease.

Find a Participating Site

Please use the map below to find a study site near you. Study sites will be added to the map once they begin enrolling patients. If there is no site that is enrolling in your location at the moment, please check back at a later stage or visit ClinicalTrials.gov to see a full list of active sites.

Phase I/II Safety and Efficacy Results

Please see below the safety and efficacy results published as part of the primary analysis of the Phase I/II study evaluating the investigational use of irinotecan liposome injection in combination with 5-FU/LV and oxaliplatin together, in study patients with previously untreated, unresectable, locally advanced, and metastatic pancreatic adenocarcinoma:

Phase I/II Safety Results1:
  • No reported Grade 3 or higher fatigue or peripheral neuropathy
  • Treatment emergent adverse events (TEAEs) Grade 3 or higher were reported by 22 of 32 study patients and included: neutropenia (31.3%), febrile neutropenia (12.5%), hypokalemia (12.5%), anemia (6.3%), diarrhea (9.4%), nausea (9.4%) and decreased neutrophil count (9.4%); vomiting occurred in 6.3% of patients
  • 8 patients reported TEAEs leading to discontinuation of oxaliplatin alone or all four study drugs (n=8/32), with 26 study patients requiring dose adjustment due to AEs
Phase I/II Efficacy Results1:
  • Study patients saw a median PFS (95% CI) of 9.2 months (7.69, 11.96) and median OS of 12.6 months (8.74, 18.69)
  • BOR (Best Overall Response) included: one complete response (CR; study participant diagnosed with locally advanced Stage III disease) in 3% (1/32), 10 partial responses (PR) in 31.3% (10/32) and 15 stable diseases (SD) in 46.9% (15/32) (sum of CR+PR+SD = 81.3%)
  • Disease control achieved by 71.9% (23/32) of study patients at 16 weeks

1Wainberg, Z.A., et al. First-line liposomal irinotecan + 5 fluorouracil/leucovorin + oxaliplatin in patients with pancreatic ductal adenocarcinoma: long-term follow-up results from a phase 1/2 study. Oral/abstract presented at the ESMO World Congress on Gastrointestinal Cancer (WCGI 2020, abstract #LBA-1). Available at https://www.annalsofoncology.org/article/S0923-7534(20)39375-3/fulltext#secsectitle0020

Eligibility Checker

Use the following form to check if your patient may be eligible for NAPOLI 3, then click Submit.

Please note that clicking Submit does not mean that your patient consents to participating in the study.

1

Has histologically or cytologically confirmed adenocarcinoma of the pancreas that has not been previously treated in the metastatic setting

2

Has had an initial diagnosis of metastatic disease (as per American Joint Committee on Cancer 8th Edition [AJCC 2017]) within ≤ 6 weeks prior to screening

3

Is not infected with human immunodeficiency virus (HIV) or, if infected with HIV, meets all the following criteria:

  • CD4 count is ≥ 350 cells/µL, viral load is undetectable, and not taking prohibited cytochrome (CYP) interacting medications

  • Probable long-term survival with HIV if cancer was not present

  • Stable on a highly active antiretroviral therapy (HAART) regimen for ≥ 4 weeks, and willing to adhere to their HAART regimen with minimal overlapping toxicity and drug-drug interactions with the experimental agents in this study

  • HIV is not multi-drug-resistant

  • Taking medication and/or receiving antiretroviral therapy that does not interact or have overlapping toxicities with the study medication

4

Has had prior treatment of pancreatic cancer in the metastatic setting with surgery, radiotherapy, chemotherapy, or investigational therapy

Important! You may select 'No' for this criterion if:

  • The radiotherapy received was palliative

  • The surgery was for a biliary stent or tube placement

5

Has had prior treatment of pancreatic adenocarcinoma with chemotherapy in the adjuvant setting

Important! You may select 'No' for this criterion if both the following sub-criteria are met:

  • 12 months have elapsed since completion of the last dose of chemotherapy

  • No persistent treatment-related toxicities are present

6

Has only locally advanced pancreatic adenocarcinoma; or neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma

7

Has a known history of central nervous system (CNS) metastases

Important! You may select 'No' for this criterion if: 

  • The patient is on a stable/decreasing dose of steroids and deemed clinically stable

8

Has a clinically significant gastrointestinal disorder, including: 

  • Hepatic disorders

  • Bleeding

  • Inflammation

  • Occlusion

  • Diarrhea > Grade 1

  • Malabsorption syndrome

  • Ulcerative colitis

  • Inflammatory bowel disease

  • Partial bowel obstruction

9

Has a history of any second malignancy in the last 2 years

Important! You may select 'No' for this criterion if:

  • The patient's second malignancy was an in-situ cancer or basal/squamous cell skin cancer

  • The patient has been continuously disease free for at least 2 years prior to screening

  • In the case of a patient with a concurrent malignancy, the malignancy is clinically stable and does not require tumor-directed treatment

10

Has concurrent illness/es that would be a relative contraindication to study participation, such as active cardiac or liver disease, including:

  • Severe arterial thromboembolic events (e.g. myocardial infarction, unstable angina pectoris, stroke) less than 6 months before screening

  • High cardiovascular risk, including (but not limited to) recent coronary stenting or myocardial infarction in the past year prior to screening

  • New York Heart Association (NYHA) Class III or IV congestive heart failure, ventricular arrhythmias, or uncontrolled blood pressure

  • Known historical or active infection with hepatitis B

  • Active infection with hepatitis C

  • Patients with hepatitis C who have been clinically cured are permitted. 'Clinically cured' is defined as persistent absence of hepatitis C RNA detected by PCR test in serum 12 weeks after completing antiviral treatment.

Submit

Your patient may be eligible.

Based on your answers, your patient is potentially eligible for the study. If you would like to be contacted by your nearest study site about your patient potentially taking part in this study, please enter your contact details below. Please note, study sites will only be added to this website as they receive IRB approval; for a full list of active sites, please visit ClinicalTrials.gov

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Your patient is not eligible

Based on your answers, this patient is currently not eligible for the study. If the answers to any of these questions change in the future, please check back again to see if your patient is eligible. Thank you for your interest.

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About NAPOLI 3 Irinotecan Liposome Injection Phase I/II Safety and Efficacy Results Eligibility Checker
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