oropharynx or hypopharynx or larynx secondary to Fanconi anemia., Patients diagnosed with unresectable and / or metastatic locoregionally advanced squamous cell carcinoma of the oral cavity
Conditions
Brief summary
Efficacy: To evaluate antitumor activity by means of: ORR according to RECIST V1.1
Detailed description
Duration of response (DoR)., Disease control rate (DCR)., Disease-free survival (DFS) according to RECIST V1.1., Overall survival (OS)., Health-related quality of life (HRQoL), Pharmacodinamics, Safety: To evaluate safety and tolerability of afatinib in participants with FA and HNSCC. Safety will be assessed by the frequency and severity of adverse events and Treatment-related adverse events (TRAEs) assessed by NCI CTCAE v5.0
Interventions
Sponsors
Fundacio Institut De Recerca De L Hospital De La Santa Creu I Sant Pau
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy: To evaluate antitumor activity by means of: ORR according to RECIST V1.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of response (DoR)., Disease control rate (DCR)., Disease-free survival (DFS) according to RECIST V1.1., Overall survival (OS)., Health-related quality of life (HRQoL), Pharmacodinamics, Safety: To evaluate safety and tolerability of afatinib in participants with FA and HNSCC. Safety will be assessed by the frequency and severity of adverse events and Treatment-related adverse events (TRAEs) assessed by NCI CTCAE v5.0 | — |
Countries
Germany, Spain
Outcome results
None listed