Status:
COMPLETED
A Study of ARQ 501 in Patients With Squamous Cell Carcinoma of the Head and Neck
Lead Sponsor:
ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
Conditions:
Head and Neck Neoplasms
Carcinoma, Squamous Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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).
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
End Date :
August 1 2007
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00358930
Start Date
July 1 2006
End Date
August 1 2007
Last Update
April 28 2009
Active Locations (9)
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1
University of South Alabama
Mobile, Alabama, United States, 36693
2
LA County Hospital
Los Angeles, California, United States, 90033
3
Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90089-0178
4
University of Chicago Medical Center
Chicago, Illinois, United States, 60637