Phase 2 Head and Neck Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 or older who have signed and dated a consent form before any trial procedures begin.
• People who have been diagnosed with Fanconi anemia.
• People who have been confirmed (through tissue or cell testing) to have a type of head or neck cancer called squamous cell carcinoma — affecting the mouth, throat, voice box, nasal area, or salivary glands — that cannot be surgically removed, or that has spread to distant parts of the body.
• People whose tumour cannot be surgically removed before starting the study drug (Afatinib) because of how the tumour has grown into surrounding structures, or because surgery is unlikely to cure it.
• People who have at least one area of cancer that can be measured on a CT or MRI scan, according to standard measurement guidelines (RECIST v1.1).
• People who have had previous cancer treatments, provided those treatments ended at least 6 weeks (or 5 half-lives of the drug, whichever is shorter) before the planned start of the study treatment.
• People who have previously had local treatments such as radiotherapy.
• People who are well enough to carry out basic daily activities — specifically, those with an ECOG performance score of 0 or 1 (confirm with trial site).
• People whose blood, kidney, and liver function results meet the minimum levels required by the trial (confirm specific values with trial site).
• Female participants who are past menopause (at least one year without a period) or who have had a surgical procedure that means they cannot become pregnant.
• Female participants of childbearing potential who agree not to try to become pregnant during the study and for at least one month after the last dose, have a negative pregnancy test within 7 days before starting, and agree to use appropriate contraception throughout.
• Female participants who agree not to breastfeed or donate eggs during the study and for at least one month after the last dose.
• Male participants who agree not to donate sperm during the study and for at least one month after the last dose.
• Male participants whose partner could become pregnant, or who is pregnant or breastfeeding, who agree to use a condom plus one highly effective form of contraception throughout the study and for at least one month after the last dose.
• People who agree not to join another interventional (treatment-based) clinical trial while participating in this study.

Who may not be able to join:

• People whose cancer could be treated with surgery aimed at curing the disease.
• People who have had major surgery less than two weeks before the planned start of treatment, or who have surgery planned for another condition.
• People who have received certain targeted cancer drugs (EGFR inhibitors or related antibody treatments) or other investigational treatments for this type of head and neck cancer within 4 weeks before entering the trial.
• People who have not yet recovered from side effects of previous cancer treatments to a mild level (Grade 2 or lower) (confirm with trial site).
• People who have had another separate cancer within the past 2 years (with some exceptions, such as certain treated skin cancers, localised prostate cancer treated with curative intent, or fully removed carcinoma in situ — confirm with trial site).
• People who have had a serious active infection in the 4 weeks before starting treatment, or who have a known HIV infection or chronic Hepatitis B or C.
• People who have had a stroke or mini-stroke, or who have a history of certain serious heart conditions, including a heart attack or unstable chest pain within the past 6 months, serious heart rhythm problems, significant heart failure, or a history of a prolonged QT interval on a heart trace (ECG).
• People who have a corrected QT interval of more than 470 milliseconds on a heart trace (ECG) at the time of screening (confirm with trial site).
• People who have a history of a serious lung condition called interstitial lung disease that required steroid treatment, or pneumonitis (lung inflammation).
• People with digestive conditions that may stop the study drug from being properly absorbed, or who have ongoing diarrhoea.
• People who are known to be allergic to Afatinib or any of its ingredients.
• Female participants who are pregnant, planning to become pregnant, or breastfeeding during the study or within one month after the last dose.
• People who, in the investigator's judgement, would not be able to follow the study requirements.
• People who are already in another clinical trial that would interfere with the scans or other measurements required in this study.
• People who have other medical conditions that, in the investigator's opinion, would make it unsafe or difficult to receive and tolerate the planned treatment.
• People with psychiatric conditions that may make it difficult to be monitored safely during the trial.

Important: Always verify eligibility with the trial site directly before applying.