Retrospective Study on the Efficacy and Tolerability of Liposomal Irinotecan

NCT05095064 | Unknown FDA Drug

• 1 other identifier: EDGE 001385
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Pancreatic Ductal Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Survival rate at 2, 4, 6, 8, 10 months from the start of treatment with Onivyde® + 5-FU/LV

  03/2022

• Progression-free survival (PFS) from the start of Onivyde® + 5-FU/LV treatment

  03/2022

• Disease control rate of patients from the start of treatment with Onivyde® + 5-FU/LV

  03/2022

• Change in baseline performance status of the patient after Onivyde® + 5-FU/LV treatment

  03/2022

• The OS from the date of diagnosis of metastatic disease

  03/2022

Interventions

Onivyde® + 5-FULV DRUG

Nanoliposomal irinotecan (Onivyde®) in combination with 5-fluorouracil and leucovorin (5-FU/LV)

Also known as: Nanoliposomal irinotecan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Metastatic pancreatic ductal adenocarcinoma

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Antwerp: lead
• Universitair Ziekenhuis Brussel: collaborator
• AZ Nikolaas: collaborator
• General Hospital Groeninge: collaborator
• University Hospital St Luc, Brussels: collaborator
• ASZ Aalst: collaborator
• Erasme University Hospital: collaborator
• Centre Hospitalier Universitaire de Liege: collaborator
• OLVZ Ziekenhuis Aalst: collaborator

Study Sites (1)

Antwerp University Hosptital

Edegem, 2650, Belgium

Location

Related Publications (1)

• Verbruggen L, Verheggen L, Vanhoutte G, Loly C, Lybaert W, Borbath I, Vergauwe P, Hendrickx K, Debeuckelaere C, de Haar-Holleman A, Van Laethem JL, Peeters M. A real-world analysis on the efficacy and tolerability of liposomal irinotecan plus 5-fluorouracil and folinic acid in metastatic pancreatic ductal adenocarcinoma in Belgium. Ther Adv Med Oncol. 2023 Aug 18;15:17588359231181500. doi: 10.1177/17588359231181500. eCollection 2023.

  PMID: 37600936 DERIVED

MeSH Terms

Interventions

irinotecan sucrosofate

Study Officials

• Marc Peeters

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2021
• First Posted: October 27, 2021
• Study Start: September 27, 2021
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: February 15, 2022

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)