Retrospective Study on the Efficacy and Tolerability of Liposomal Irinotecan

Metastatic Pancreatic Ductal Adenocarcinoma Clinical Trial

— NALIRI  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05095064
• Other study ID #: EDGE 001385
• Status: Active, not recruiting
• Start date: September 27, 2021
• Est. completion date: March 1, 2022

Study information

• Verified date: October 2021
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: March 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Metastatic Pancreatic Ductal Adenocarcinoma

Intervention

Drug:
• Onivyde® + 5-FULV
Nanoliposomal irinotecan (Onivyde®) in combination with 5-fluorouracil and leucovorin (5-FU/LV)

Locations

Country	Name	City	State
Belgium	Antwerp University Hosptital	Edegem

Sponsors (9)

Lead Sponsor	Collaborator
University Hospital, Antwerp	ASZ Aalst, AZ Nikolaas, Centre Hospitalier Universitaire de Liege, Erasme University Hospital, General Hospital Groeninge, OLVZ Ziekenhuis Aalst, Universitair Ziekenhuis Brussel, University Hospital St Luc, Brussels

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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