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

Sponsor
Servier Affaires Médicales (Industry)
Overall Status
Recruiting
CT.gov ID
NCT06155136
Collaborator
(none)
150
Enrollment
1
Location
3.8
Anticipated Duration (Months)
39
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    150 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Real-world Evidence on Patients With Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) Long-term Survival After Treatment With Liposomal Irinotecan (NALLONG)
    Actual Study Start Date :
    Oct 6, 2023
    Anticipated Primary Completion Date :
    Jan 31, 2024
    Anticipated Study Completion Date :
    Jan 31, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Disease characteristic according to age [Through study completion (approximatively 5 months)]

      Tumor stage (localized/locally advanced/metastatic)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Klinikum der Universität München, - Anstalt des öffentlichen Rechts - Munich Germany 81377

    Sponsors and Collaborators

    • Servier Affaires Médicales

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Servier Affaires Médicales
    ClinicalTrials.gov Identifier:
    NCT06155136
    Other Study ID Numbers:
    • DIM-95013-001-INT
    First Posted:
    Dec 4, 2023
    Last Update Posted:
    Dec 4, 2023
    Last Verified:
    Nov 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Dec 4, 2023