RecruitingPhase 1Phase 2NCT06648096

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

Phase Ib/II Study to Investigate the Safety and Efficacy of Afatinib When Administered as Therapy in Fanconi Anemia Patients With Unresectable and / or Metastatic Locoregionally Advanced Squamous Cell Carcinoma of the Oral Cavity, Oropharynx or Hypopharynx or Larynx.

Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Enrollment

25 participants

Start Date

Nov 8, 2024

Study Type

INTERVENTIONAL

Conditions

Head and Neck Squamous Cell Carcinoma Fanconi Anemia

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing afatinib — a targeted drug normally used for lung cancer — in patients with Fanconi anemia (a rare genetic disorder) who have advanced head and neck cancer. Because standard chemotherapy is very toxic for people with Fanconi anemia, this trial is exploring a gentler alternative. **You may be eligible if...** - You are 18 or older - You have a confirmed diagnosis of Fanconi anemia - You have advanced squamous cell carcinoma of the head and neck (mouth, throat, larynx, nasal area, or salivary glands) - Your cancer cannot be removed surgically or has spread to distant sites **You may NOT be eligible if...** - You are intolerant to afatinib or similar drugs - Your overall health is too poor to safely receive treatment - You have serious organ dysfunction Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAfatinib

Afatinib starting at 20 mg (weeks 1-2), escalating to 30 mg after two weeks (weeks 3-4) and escalating to 40 mg after one month (week 5 - thereafter) if no hematologic or other relevant toxicities are observed (CTCAE V5.0 \< grade 2)