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Trial record 5 of 61 for:    NRG1
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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05107193
Expanded Access Status : No longer available
First Posted : November 4, 2021
Last Update Posted : November 8, 2022
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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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
Solid Tumors Drug: afatinib

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
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Study Type : Expanded Access
Expanded Access Type : Treatment IND/Protocol
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

Resource links provided by the National Library of Medicine


Interventions
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Intervention Details:
  • Drug: afatinib
    afatinib
    Other Name: GILOTRIF®
Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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More Information
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Additional Information:

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT05107193    
Other Study ID Numbers: 1200-0344
First Posted: November 4, 2021    Key Record Dates
Last Update Posted: November 8, 2022
Last Verified: November 2022
Keywords provided by Boehringer Ingelheim:
NRG1 fusion
Additional relevant MeSH terms:
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Neoplasms
Afatinib
Antineoplastic Agents
 Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action