OncoMatch/Clinical Trials/NCT06648096
Afatinib in Patients with Fanconi Anemia (FA) and Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)
Is NCT06648096 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Afatinib for fanconi anemia.
Treatment: Afatinib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: egfr tyrosine kinase inhibitor
Lab requirements
Blood counts
Neutrophils > 1000/μL; Platelets > 50,000/μL; Hemoglobin > 8 g/dL
Kidney function
Creatinine < 1.5 x ULN with clearance > 50 mL/min
Liver function
Total bilirubin < 1.5 x ULN (Gilbert's < 2 x ULN); AST and ALT < 2.5 x ULN or < 5 x ULN if liver metastases present
Cardiac function
INR and PT < 1.5 x ULN; QTc interval (corrected) ≤ 470 msec; No NYHA class III or greater CHF or LVEF < 40%
Adequate organ and bone marrow functions, as defined below: Neutrophils > 1000 cells / microliter. Platelets > 50,000 cells / microliter. Hemoglobin > 8 g / dL. Creatinine < 1.5 x upper limit normal (ULN) with clearance > 50 mL / min. Total bilirubin < 1.5 x ULN. Note: patients with Gilbert's may be included with bilirubin <2 x ULN. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 x ULN or < 5 ULN if liver metastases are present. International normalized ratio (INR) and prothrombin time (PT) <1.5 x ULN. Participants with QTc interval (corrected) > 470 msec at screening [excluded]. NYHA class III or greater congestive heart failure or left ventricular ejection fraction of < 40% [excluded].
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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