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

History of Changes

Tracking Information
First Received Date ^ICMJE	July 28, 2006
Last Updated Date	April 27, 2009
Start Date ^ICMJE	July 2006
Primary Completion Date	August 2007 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 28, 2006)	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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00358930 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: July 28, 2006)	Determine the progression-free survival (PFS) at six months for those patients treated with ARQ 501.To further characterize the safety ARQ 501.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Study of ARQ 501 in Patients With Squamous Cell Carcinoma of the Head and Neck
Official Title ^ICMJE	A Phase 2 Study of ARQ 501 in Patients With Locally Advanced, Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
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).
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Head and Neck Neoplasms Carcinoma, Squamous Cell
Intervention ^ICMJE	Drug: ARQ 501
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	60
Completion Date	August 2007
Primary Completion Date	August 2007 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Able to provide signed and dated informed consent document prior to study-specific screening procedures. Histologically or cytologically confirmed locally advanced, recurrent or metastatic SCCHN. Measurable disease per RECIST. ≥ 18 years old. Karnofsky performance status (KPS) ≥ 70%. 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. Hemoglobin (Hgb) ≥ 10 g/dL. Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L (≥ 1,500/mm³). Platelet count ≥ 100 x 10^9/L ( ≥ 100,000/mm³). 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. 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. Creatinine less than or equal to 1.5 x ULN. Exclusion Criteria: Primary tumor of nasopharyngeal origin. Eligible for curative surgery or radiotherapy. Received three or more systemic anticancer regimens. Have active, uncontrolled systemic infection considered opportunistic, life threatening or clinically significant at the time of treatment. Have received anticancer chemotherapy, immunotherapy, radiotherapy, or investigational agents within three weeks of first infusion. Surgery within two weeks of first infusion. Have symptomatic or untreated central nervous system (CNS) involvement. Are pregnant or lactating. Previous exposure to ARQ 501.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00358930
Other Study ID Numbers ^ICMJE	ARQ 501-208
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	ArQule
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	ArQule
Verification Date	April 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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