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A Phase II Study of AZD0530 for Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)
This phase II trial is studying the how well saracatinib works in treating patients with metastatic or recurrent head and neck cancer. Saracatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
PRIMARY OBJECTIVES: I. To determine the median progression-free survival for patients with advanced or recurrent squamous cell carcinoma of the head and neck (HNSCC) treated with AZD0530 (saracatinib). SECONDARY OBJEC TIVES: I. To determine overall survival for patients with advanced or recurrent HNSCC treated with AZD0530. II. To determine objective response rate for patients with advanced or recurrent HNSCC treated with AZD0530. III. For patients with accessible tumors, to perform pre and post-treatment biopsies to assess the pharmacodynamic effects of AZD0530 on c-Src and downstream signaling molecules STAT3 and STAT5. OUTLINE: Patients receive saracatinib orally (PO) or by percutaneous endoscopic gastrostomy (PEG) tube once daily (QD) on days 1-56. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 12 weeks and then periodically thereafter.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Start Date
July 1, 2007
Primary Completion Date
March 1, 2011
Completion Date
March 1, 2011
Last Updated
April 30, 2014
9
ACTUAL participants
saracatinib
DRUG
laboratory biomarker analysis
OTHER
Lead Sponsor
National Cancer Institute (NCI)
NCT01473784
NCT00939627
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