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

Phase 2

Completed

• Conditions: Head and Neck Neoplasms; Carcinoma, Squamous Cell

• Registration Number: NCT00358930
• Lead Sponsor: ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2006-07-28
• Study First Submitted QC: 2006-07-28
• Study First Posted: 2006-08-01
• Primary Completion: 2007-08
• Study Completion: 2007-08
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-27
• Last Update Posted: 2009-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Determine the progression-free survival (PFS) at six months for those patients treated with ARQ 501.To further characterize the safety ARQ 501.

Trial Locations

Locations (9)

Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States

LA County Hospital; 🇺🇸 Los Angeles, California, United States

University of South Alabama; 🇺🇸 Mobile, Alabama, United States

Washington University School of Medicine; 🇺🇸 St. Louis, Missouri, United States

New York Oncology Hematology; 🇺🇸 Albany, New York, United States

University of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States

Mary Crowley Medical Research Center; 🇺🇸 Dallas, Texas, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Dana-Farber; 🇺🇸 Boston, Massachusetts, United States