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

Inclusion criteria

• Able to provide signed and dated informed consent document prior to study-specific screening procedures.
• Histologically or cytologically confirmed locally advanced, recurrent or metastatic SCCHN.
• Measurable disease per RECIST.
• ≥ 18 years old.
• Karnofsky performance status (KPS) ≥ 70%.
• 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.
• Hemoglobin (Hgb) ≥ 10 g/dL.
• Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L (≥ 1,500/mm³).
• Platelet count ≥ 100 x 10^9/L ( ≥ 100,000/mm³).
• 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.
• 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.
• Creatinine less than or equal to 1.5 x ULN.

Exclusion criteria

• Primary tumor of nasopharyngeal origin.
• Eligible for curative surgery or radiotherapy.
• Received three or more systemic anticancer regimens.
• Have active, uncontrolled systemic infection considered opportunistic, life threatening or clinically significant at the time of treatment.
• Have received anticancer chemotherapy, immunotherapy, radiotherapy, or investigational agents within three weeks of first infusion.
• Surgery within two weeks of first infusion.
• Have symptomatic or untreated central nervous system (CNS) involvement.
• Are pregnant or lactating.
• Previous exposure to ARQ 501.