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Retrospective Study on the Efficacy and Tolerability of Liposomal Irinotecan

NCT05095064 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2022-02-15

No results posted yet for this study

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

Interventions

DRUG

Onivyde® + 5-FULV

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

Sponsors & Collaborators

  • Universitair Ziekenhuis Brussel

    collaborator OTHER

  • AZ Nikolaas

    collaborator OTHER

  • General Hospital Groeninge

    collaborator OTHER

  • University Hospital St Luc, Brussels

    collaborator OTHER

  • ASZ Aalst

    collaborator OTHER

  • Erasme University Hospital

    collaborator OTHER

  • Centre Hospitalier Universitaire de Liege

    collaborator OTHER

  • OLVZ Ziekenhuis Aalst

    collaborator UNKNOWN

  • University Hospital, Antwerp

    lead OTHER

Principal Investigators

  • Marc Peeters · University Hospital, Antwerp

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-27
Primary Completion
2022-03-01
Completion
2022-03-01
FDA Drug
Yes

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05095064 on ClinicalTrials.gov