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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00358930
Recruitment Status : Completed
First Posted : August 1, 2006
Last Update Posted : April 28, 2009
Sponsor:
Information provided by:
ArQule

Study Description
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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).

Condition or disease Intervention/treatment Phase
Head and Neck Neoplasms Carcinoma, Squamous Cell Drug: ARQ 501 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2006
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. Determine the progression-free survival (PFS) at six months for those patients treated with ARQ 501.To further characterize the safety ARQ 501.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00358930


Locations
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United States, Alabama
University of South Alabama
Mobile, Alabama, United States, 36693
United States, California
LA County Hospital
Los Angeles, California, United States, 90033
Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90089-0178
United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Dana-Farber
Boston, Massachusetts, United States, 02218
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, New York
New York Oncology Hematology
Albany, New York, United States, 12208
United States, Texas
Mary Crowley Medical Research Center
Dallas, Texas, United States, 75201
Sponsors and Collaborators
ArQule
More Information
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ClinicalTrials.gov Identifier: NCT00358930    
Other Study ID Numbers: ARQ 501-208
First Posted: August 1, 2006    Key Record Dates
Last Update Posted: April 28, 2009
Last Verified: April 2009
Keywords provided by ArQule:
squamous cell carcinoma of the head and neck
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
 Beta-lapachone
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents