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

Head and Neck Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00358930
• Other study ID #: ARQ 501-208
• Status: Completed
• Phase: Phase 2
• First received: July 28, 2006
• Last updated: April 27, 2009
• Start date: July 2006
• Est. completion date: August 2007

Study information

• Verified date: April 2009
• Source: ArQule
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Neoplasms

Intervention

Drug:
• ARQ 501

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
ArQule

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Determine the progression-free survival (PFS) at six months for those patients treated with ARQ 501.To further characterize the safety ARQ 501.