Phase 2 Study of Afatinib in Advanced Cutaneous Squamous Cell Carcinoma
H. Lee Moffitt Cancer Center and Research Institute
Summary
The primary purpose of this study is to find out if Afatinib can help treat participants with advanced cSCC.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age ≥ 18 years at the time of informed consent * ECOG performance status ≤2 * Adequate bone marrow, organ function and laboratory parameters: * ANC ≥ 1.0 × 109/L; * Hemoglobin ≥ 8 g/dL; * Platelets ≥ 75 × 109/L; * AST and ALT ≤5 × ULN * Calculated creatinine clearance \> 15mL/min by Cockroft-Gault formula * Histologic diagnosis of invasive cutaneous squamous cell carcinoma, that is deemed not appropriate for further surgical intervention and/or radiation therapy. Participants may have either locally advanced or metastatic disease. * At least 1 measurable lesion - either…
Interventions
- DrugAfatinib 40 MG
Participants will receive 40 mg Afatinib, once daily.
Location
- Moffitt Cancer CenterTampa, Florida