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

Study Overview
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Brief Summary
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This is a Phase 2, multi-center, open label study of ARQ 501 in patients with locally advanced, recurrent or metastatic squamous cell cancer of the head and neck (SCCHN).

Official Title
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A Phase 2 Study of ARQ 501 in Patients With Locally Advanced, Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

Conditions
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Head and Neck Neoplasms, Carcinoma, Squamous Cell

Intervention / Treatment
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* Drug: ARQ 501


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ARQ 501|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the overall response rate (ORR) of patients with locally advanced, recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) treated with ARQ 501. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the progression-free survival (PFS) at six months for those patients treated with ARQ 501.To further characterize the safety ARQ 501. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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squamous cell carcinoma of the head and neck