A Phase 2 Study of AZD0530 in Patients With Metastatic or Locally Advanced Gastric Carcinoma
I. To assess the objective disease control rate (i.e., partial or complete response as
defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria or stable disease
for ≥ 16 weeks) in patients with locally advanced or metastatic adenocarcinoma of the
stomach or gastroesophageal junction treated with AZD0530 (saracatinib).
I. To assess the median time to disease progression, median overall survival, and 1-year
survival rate in these patients.
II. To assess the toxicity of AZD0530 in these patients. III. To evaluate potential
predictive markers by assessing pretreatment intratumoral levels of src, Y419 phospho-src
(P-Src), and c-terminal src kinase (Csk) in archival tumor biopsies.
Patients receive saracatinib orally (PO) once daily (QD) in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at least every 2 months.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective tumor response (defined as partial [PR] or complete response [CR] by RECIST criteria)
PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. CR is defined as disappearance of all non-target lesions and normalization of tumor marker level.
Every 2 weeks for the first 4 weeks, and then every 4-8 weeks thereafter
University Health Network-Princess Margaret Hospital
United States: Food and Drug Administration
|Hamilton Medical Center||Dalton, Georgia 30720|