Afatinib (GILOTRIF®) in Patients Suffering From Tumors Harboring Neuregulin 1 (NRG1) Gene Alterations (Specifically NRG1 Gene Fusion-positive Advanced Solid Tumors)
- Conditions
- Solid Tumors
- Registration Number
- NCT05107193
- Lead Sponsor
- Boehringer Ingelheim
- 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.
- 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.
Recruitment & Eligibility
- Status
- NO_LONGER_AVAILABLE
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Not provided
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
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method