A Study of ARQ 501 in Patients With Squamous Cell Carcinoma of the Head and Neck

Inclusion Criteria

• •1. Able to provide signed and dated informed consent document prior to study-specific screening procedures.
• •2. Histologically or cytologically confirmed locally advanced, recurrent or metastatic SCCHN.
• •3. Measurable disease per RECIST.
• •4. ≥ 18 years old.
• •5. Karnofsky performance status (KPS) ≥ 70%.
• •6. Male or female patients of child-producing potential must agree to use contraception or avoidance of pregnancy measures during the study and for 30 days after the last infusion of ARQ 501.
• •7. Hemoglobin (Hgb) ≥ 10 g/dL.
• •8. Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L (≥ 1,500/mm³).
• •9. Platelet count ≥ 100 x 10\^9/L ( ≥ 100,000/mm³).
• •10. Total bilirubin less than or equal to 1.5 x upper limit of normal (ULN) or less than or equal to 3.0 x ULN with metastatic liver disease.
• •11. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 2.5 x ULN or less than or equal to 5.0 x ULN with metastatic liver disease.
• •12. Creatinine less than or equal to 1.5 x ULN.