Retrospective Study on the Efficacy and Tolerability of Liposomal Irinotecan (NALIRI)

Retrospective Study on the Efficacy and Tolerability of Liposomal irinotecanN (MM398, PEP02, Onivyde) for the Treatment of Pancreatic Adenocarcinoma.

The aim of this retrospective study is to confirm the efficacy and safety results obtained in the NAPOLI-1-study, when Onivyde® in combination with 5-FU/LV is used in real-life practice in Belgium. The data needed to do so will be obtained using information that is routinely collected as part of patient's medical care.

Study Overview

• Status: Active, not recruiting
• Conditions: Metastatic Pancreatic Ductal Adenocarcinoma
• Intervention / Treatment: Drug: Onivyde® + 5-FULV

Detailed Description

Patients with pancreatic cancer have a poor prognosis with a 5-years survival of only 1-2%. This arises from the fact that it is typically diagnosed late, when curative resection is impossible. These patients are thus restricted to chemotherapy, with gemcitabine-based therapies being the standard of care for patients with locally advanced or metastatic pancreatic ductal adenocarcinoma (mPDAC). However, even after second or subsequent lines of therapy, disease progression is inevitable. Therefore, the need for new treatment options is high. Recently, the advantage of using nanoliposomal irinotecan (Onivyde®) in combination with 5-fluorouracil and leucovorin (5-FU/LV) over the use of 5-FU/LV alone was demonstrated in a phase-3 randomized clinical trial (NAPOLI-1 trial). As this study showed significant improvement on overall survival, progression-free survival, time to treatment failure, overall response rate and tumor marker CA19-9 response, on October 14 2016 this therapy was approved by the EMA to be used for patients with mPDAC previously treated with gemcitabine-based therapy.

While randomized clinical trials, like the NAPOLI-1 trial, are considered the reference standard for comparing the efficacy and safety of treatments, these studies do not always reflect the everyday clinical practice. Therefore, the aim of this study is to evaluate the efficacy and safety of Onivyde® in real-life practice in Belgium. This information would be very valuable to determine the value of the drug and improve the knowledge of the actual use of Onivyde® after marketing authorization.

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• Belgium
  • Edegem, Belgium, 2650
    • Antwerp University Hosptital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Metastatic pancreatic ductal adenocarcinoma

Description

Inclusion Criteria:

• Patient has diagnosis of pancreatic adenocarcinoma with documented metastatic disease.
• Patient progressed after gemcitabine-based therapy.
• Patient received at least one treatment cycle with Onivyde® + 5-FU/LV 5FU in the context of post-gemcitabine based therapy of mPDAC.

Exclusion Criteria:

• Patient has not received at least one treatment cycle with Onivyde® + 5-FU/LV.
• Previous irinotecan-based therapy in metastatic setting.
• Patientstarted the treatment with Onivyde® + 5-FU/LV after 01/04/2021

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The overall survival (OS) from start of treatment with Onivyde® + 5-FU/LV	All this info is retrospectively obtained from the patients medical fistory. Data analysis is forseen to be finished 03/2022.	03/2022

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival rate at 2, 4, 6, 8, 10 months from the start of treatment with Onivyde® + 5-FU/LV	All this info is retrospectively obtained from the patients medical history. Data analysis is forseen to be finished 03/2022.	03/2022
Progression-free survival (PFS) from the start of Onivyde® + 5-FU/LV treatment	All this info is retrospectively obtained from the patients medical history. Data analysis is forseen to be finished 03/2022.	03/2022
Disease control rate of patients from the start of treatment with Onivyde® + 5-FU/LV	All this info is retrospectively obtained from the patients medical history. Data analysis is forseen to be finished 03/2022.	03/2022
Change in baseline performance status of the patient after Onivyde® + 5-FU/LV treatment	All this info is retrospectively obtained from the patients medical history. Data analysis is forseen to be finished 03/2022.	03/2022
The OS from the date of diagnosis of metastatic disease	All this info is retrospectively obtained from the patients medical history. Data analysis is forseen to be finished 03/2022.	03/2022

Collaborators and Investigators

• Sponsor: University Hospital, Antwerp
• Collaborators: Universitair Ziekenhuis Brussel; General Hospital Groeninge; AZ Nikolaas; Erasme University Hospital; Centre Hospitalier Universitaire de Liege; ASZ Aalst; University Hospital St Luc, Brussels; OLVZ Ziekenhuis Aalst
• Investigators: Principal Investigator: Marc Peeters, University Hospital, Antwerp

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2021
• Primary Completion (Anticipated): March 1, 2022
• Study Completion (Anticipated): March 1, 2022

Study Registration Dates

• First Submitted: September 21, 2021
• First Submitted That Met QC Criteria: October 13, 2021
• First Posted (Actual): October 27, 2021

Study Record Updates

• Last Update Posted (Actual): February 15, 2022
• Last Update Submitted That Met QC Criteria: January 31, 2022
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase Inhibitors; Topoisomerase I Inhibitors; Irinotecan
• Other Study ID Numbers: EDGE 001385

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No