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

A Phase 2 Study of ARQ 501 in Patients With Locally Advanced, Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

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).

Study Overview

• Status: Completed
• Conditions: Head and Neck Neoplasms; Carcinoma, Squamous Cell
• Intervention / Treatment: Drug: ARQ 501

• Study Type: Interventional
• Enrollment: 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36693
      • University Of South Alabama
  • California
    • Los Angeles, California, United States, 90033
      • LA County Hospital
    • Los Angeles, California, United States, 90089-0178
      • Norris Comprehensive Cancer Center
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Dana-Farber Cancer Institute
    • Boston, Massachusetts, United States, 02218
      • Dana-Farber
  • Missouri
    • St. Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • New York
    • Albany, New York, United States, 12208
      • New York Oncology Hematology
  • Texas
    • Dallas, Texas, United States, 75201
      • Mary Crowley Medical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: ArQule, Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)

Study record dates

Study Major Dates

• Study Start: July 1, 2006
• Primary Completion (Actual): August 1, 2007
• Study Completion (Actual): August 1, 2007

Study Registration Dates

• First Submitted: July 28, 2006
• First Submitted That Met QC Criteria: July 28, 2006
• First Posted (Estimate): August 1, 2006

Study Record Updates

• Last Update Posted (Estimate): April 28, 2009
• Last Update Submitted That Met QC Criteria: April 27, 2009
• Last Verified: April 1, 2009

More Information

Terms related to this study

• Keywords: squamous cell carcinoma of the head and neck
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Head and Neck Neoplasms; Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Beta-lapachone
• Other Study ID Numbers: ARQ 501-208