RWE on Patients With mPDAC Long-term Survival After Treatment With Liposomal Irinotecan (NALLONG)

April 19, 2024 updated by: Servier Affaires Médicales

Real-world Evidence on Patients With Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) Long-term Survival After Treatment With Liposomal Irinotecan (NALLONG)

The objective is to describe mPDAC patients still alive one year after the first cycle of nal-IRI

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

The objectives on patients still alive one year after the first cycle of nal-IRI :

  • Characterize mPDAC patient population according to their demographics
  • Identify PDAC treatment by line of treatment from diagnosis to last treatment
  • Explore prognostic factors of longer Overall Survival (OS) and Progression Free Survivor (PFS) among mPDAC patients showing long-term Survival

Study Type

Observational

Enrollment (Actual)

163

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Munich, Germany, 81377
        • Klinikum der Universität München, - Anstalt des öffentlichen Rechts -

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients still alive one year after the initiation of NAliri

Description

Inclusion Criteria:

  • Age ≥ 18 years (≥ 19 years in South Korea)
  • Cytologically confirmed mPDAC at initiation of the nal-IRI treatment
  • All patients receiving a nal-IRI + 5-flurouracil/leucovorin regimen should have been pre-treated with a gemcitabine-based regimen
  • Initiation of a systemic therapy with nal-IRI (index date) during the study eligibility period (between January 1, 2018, and December 31, 2021)
  • At least one cycle of nal-IRI-containing regimen should have been administered
  • A minimum 1-year survival from the index date (initiation date of nal-IRI-containing regimen)
  • Availability of data related to survival outcomes in the patient medical record
  • Patients deceased or not at the time of enrollment will be eligible for inclusion in the study

Exclusion Criteria:

  • No documentation of systemic therapy outcomes or prior treatments in patient medical records
  • Patients with second concomitant metastatic malignancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease characteristic according to age
Time Frame: Through study completion (approximatively 5 months)
Tumor stage (localized/locally advanced/metastatic)
Through study completion (approximatively 5 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Servier Affaires Médicales

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 6, 2023

Primary Completion (Actual)

March 30, 2024

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

November 24, 2023

First Submitted That Met QC Criteria

November 24, 2023

First Posted (Actual)

December 4, 2023

Study Record Updates

Last Update Posted (Actual)

April 22, 2024

Last Update Submitted That Met QC Criteria

April 19, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • DIM-95013-001-INT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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