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NCT05107193 Clinical Trial

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

Solid Tumors Clinical Trial

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

Clinical Trial Details — Status: No longer available

Administrative data
NCT number NCT05107193
Other study ID # 1200-0344
Secondary ID
Status No longer available
Phase
First received
Last updated

Study information
Verified date November 2022
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.

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.

Recruitment information / eligibility
Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• afatinib
afatinib

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Boehringer Ingelheim
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