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

This study has been completed.
Sponsor:
Information provided by:
ArQule
ClinicalTrials.gov Identifier:
NCT00358930
First received: July 28, 2006
Last updated: April 27, 2009
Last verified: April 2009
  Purpose

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 Intervention Phase
Head and Neck Neoplasms
Carcinoma, Squamous Cell
Drug: ARQ 501
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by ArQule:

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

Estimated Enrollment: 60
Study Start Date: July 2006
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00358930

Locations
United States, Alabama
University of South Alabama
Mobile, Alabama, United States, 36693
United States, California
Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90089-0178
LA County Hospital
Los Angeles, California, United States, 90033
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

No publications provided

ClinicalTrials.gov Identifier: NCT00358930     History of Changes
Other Study ID Numbers: ARQ 501-208
Study First Received: July 28, 2006
Last Updated: April 27, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by ArQule:
squamous cell carcinoma of the head and neck

Additional relevant MeSH terms:
Neoplasms
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Neoplasms by Site
Beta-lapachone
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents

ClinicalTrials.gov processed this record on August 28, 2014