Clinical trial NCT00358930: A Study of ARQ 501 in Patients With Squamous Cell Carcinoma of the Head and Neck
Official title: A Phase 2 Study of ARQ 501 in Patients With Locally Advanced, Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head and Neck Neoplasms
Carcinoma, Squamous Cell
Keywords: 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)
Sponsor class: INDUSTRY
First posted: 2006-08-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: 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 outcomes:
measure: Determine the progression-free survival (PFS) at six months for those patients treated with ARQ 501.To further characterize the safety ARQ 501.
Other outcomes:
Locations:
city: Mobile
country: United States
facility: University of South Alabama
state: Alabama
city: Los Angeles
country: United States
facility: LA County Hospital
state: California
city: Los Angeles
country: United States
facility: Norris Comprehensive Cancer Center
state: California
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber
state: Massachusetts
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Albany
country: United States
facility: New York Oncology Hematology
state: New York
city: Dallas
country: United States
facility: Mary Crowley Medical Research Center
state: Texas
Study officials:
References: