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.
Written informed consent according to local guidelines, must be signed and dated by the participant and investigator prior to performing any protocol procedure.
Patient is ≥ 18 years of age.
Confirmed diagnosis of Fanconi anemia.
Histologically or cytologically confirmed unresectable or locoregionally advanced squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, larynx, nasopharynx, paranasal sinuses or salivary glands. Patients with distal metastasis (M1, American Joint Cancer Committee (AJCC) 8th ed.) are also eligible.
Patients who are candidates for surgery with curative intent are not eligible.
Less than two weeks from surgical resection or other major surgical procedure at start of treatment. Planned surgery for other diseases.
Previous treatment with EGFR small molecule inhibitors, EGFR inhibitory antibodies and / or any investigational agents for the treatment of HNSCC within 4 weeks prior to the selection was not allowed.
Patient must have recovered from any previous treatment toxicity to Grade ≤ 2.
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Lead sponsor
MFAR Clinical Research S.L.
Collaborator