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


Phase 2
18 Years
N/A
Not Enrolling
Both
Head and Neck Neoplasms, Carcinoma, Squamous Cell

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

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.

Authority:

United States: Food and Drug Administration

Study ID:

ARQ 501-208

NCT ID:

NCT00358930

Start Date:

July 2006

Completion Date:

August 2007

Related Keywords:

  • Head and Neck Neoplasms
  • Carcinoma, Squamous Cell
  • squamous cell carcinoma of the head and neck
  • Neoplasms
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

Name

Location

Washington University School of MedicineSaint Louis, Missouri  63110
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Mary Crowley Medical Research CenterDallas, Texas  75246
University of Chicago Medical CenterChicago, Illinois  60637
New York Oncology HematologyAlbany, New York  12208
University of South AlabamaMobile, Alabama  36693
Norris Comprehensive Cancer CenterLos Angeles, California  90033
LA County HospitalLos Angeles, California  90033
Dana-FarberBoston, Massachusetts  02218