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

Completed · Phase 2

Conditions studied: Head and Neck Neoplasms, Carcinoma, Squamous Cell

In brief

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).

Key facts

Study ID

NCT00358930

Run by

ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)

People needed

60

Starts

2006-07-01

Expected to finish

2007-08-01

Last updated by the study team

2009-04-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of South Alabama — Mobile, Alabama, United States
• LA County Hospital — Los Angeles, California, United States
• Norris Comprehensive Cancer Center — Los Angeles, California, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Dana-Farber — Boston, Massachusetts, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• New York Oncology Hematology — Albany, New York, United States
• Mary Crowley Medical Research Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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