Afatinib in Patients With Fanconi Anemia (FA) and Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)

Summary

This research study is a phase Ib/II, single-arm, non-randomized, non-blind, multicenter study designed to determine whether Afatinib is effective and safe in patients with locoregionally unresectable and / or metastatic HNSCC with Fanconi Anemia. The main hypothesis, based on preclinical evidence, is that treatment with afatinib, an epithelial growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), could be an effective treatment option to control cancer for patients with FA - HNSCC.

Timeline

Start

2024-11-08

Primary completion

2028-12

Completion

2028-12

Publications

• Anguera G, Gallego O, Llobet M, Berga N, Moreno-Martinez ME, Leon X, Kratz C, Garcia-Escudero R, Minguillon J, Surralles J. Opening of a phase Ib/II study to investigate the safety and efficacy of Afatinib in patients with Fanconi anemia and unresectable locally advanced or metastatic head and neck squamous cell carcinoma. BMC Cancer. 2025 Aug 26;25(1):1374. doi: 10.1186/s12885-025-14619-6.

Drugs

Indications