Tongue Cancer Clinical Trial
Official title:
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.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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