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Afatinib (GILOTRIF®) in Patients Suffering From Tumors Harboring Neuregulin 1 (NRG1) Gene Alterations (Specifically NRG1 Gene Fusion-positive Advanced Solid Tumors)

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Available
CT.gov ID
NCT05107193
Collaborator
(none)

Study Details

Study Description

Brief Summary

Gene fusions are defined as two separate genes joined together (gene 1, gene 2), generating a novel fusion gene. NRG1 fusions are rare and complex with regard to the fusion/fusion partner. The specific NRG1 gene fusion will be identified by a specialized molecular testing lab.

Condition or Disease Intervention/Treatment Phase

Detailed Description

Afatinib is provided on a single-patient protocol basis to patients suffering from tumors harboring NRG1 fusions, a disease for which no satisfactory authorised alternative therapy exists.

In the context of this mechanism it is planned to collect and analyze limited clinical data in order to investigate the safety and efficacy of afatinib in patients with advanced and/or metastatic solid tumours harboring NRG1 gene fusions.

Study Design

Study Type:
Expanded Access
Official Title:
Assessment of Prospective Real-world Outcomes Based on Single-patient Protocol Data Collection of Afatinib (GILOTRIF®) Use in Patients With Solid Tumors Harboring NRG1 Gene Fusions

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria to participate in this program:
    • Confirmed diagnosis of an advanced, unresectable and/or metastatic tumor harboring
    NRG1 gene fusions characterized as follows:

    • Gene 1: NRG1 (prerequisite: conservation of the epidermal growth factor (EGF) domain - this will be identified by the lab performing the molecular testing)

    • Gene 2: All fusion partners are allowed (prerequisite: the region must be a coding region - this will be identified by the lab performing the molecular testing)

    • Patient must have measurable or evaluable lesions (according to RECIST 1.1).

    • At least 18 years of age at the time of consent.

    Exclusion Criteria:

    • Treatment with a systemic anti-cancer therapy or investigational drug within 14 days or 5 half-lives (whichever is shorter) of the first treatment with the study medication.

    • Tumors carrying additional gene mutations other than NRG1 fusion where FDA-approved targeted therapy is available

    • Prior treatment with a therapy targeting erythroblastic leukemia viral oncogene homologue receptors (ErbB)

    • Any patient considered ineligible by the treating physician.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Boehringer Ingelheim

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Boehringer Ingelheim
    ClinicalTrials.gov Identifier:
    NCT05107193
    Other Study ID Numbers:
    • 1200-0344
    First Posted:
    Nov 4, 2021
    Last Update Posted:
    Aug 9, 2022
    Last Verified:
    Aug 1, 2022
    Keywords provided by Boehringer Ingelheim
    NRG1 fusion
    Additional relevant MeSH terms:
    Neoplasms
    Afatinib

    Study Results

    No Results Posted as of Aug 9, 2022