A Phase II Study of AZD0530 for Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)
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
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.
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
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST). Progression-free survival (PFS) is measured from the date of first treatment to the date of disease progression or death. The Kaplan-Meier method will be used to estimate PFS.
From the start of treatment for up to 12 weeks
Memorial Sloan-Kettering Cancer Center
United States: Food and Drug Administration
|Memorial Sloan Kettering Cancer Center||New York, New York 10021|