NALIRI: Retrospective Study on the Efficacy and Tolerability of Liposomal Irinotecan

Sponsor

University Hospital, Antwerp (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05095064

Collaborator

Universitair Ziekenhuis Brussel (Other), AZ Nikolaas (Other), General Hospital Groeninge (Other), University Hospital St Luc, Brussels (Other), ASZ Aalst (Other), Erasme University Hospital (Other), Centre Hospitalier Universitaire de Liege (Other), OLVZ Ziekenhuis Aalst (Other)

Enrollment

Location

5.1

Anticipated Duration (Months)

11.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Pancreatic Ductal Adenocarcinoma	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 Design

Study Type:

Observational

Anticipated Enrollment :

60 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Sep 27, 2021

Anticipated Primary Completion Date :

Mar 1, 2022

Anticipated Study Completion Date :

Mar 1, 2022

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Antwerp University Hosptital	Edegem		Belgium	2650

Investigators

Principal Investigator: Marc Peeters, UZA

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Antwerp

ClinicalTrials.gov Identifier:

NCT05095064

Other Study ID Numbers:

EDGE 001385

First Posted:

Oct 27, 2021

Last Update Posted:

Feb 15, 2022

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Adenocarcinoma

Irinotecan

Study Results

No Results Posted as of Feb 15, 2022