Adenocarcinoma of the Gastroesophageal Junction Clinical Trial
Official title:
A Phase 2 Study of AZD0530 in Patients With Metastatic or Locally Advanced Gastric Carcinoma
This phase II trial is studying how well saracatinib works in treating patients with locally advanced or metastatic stomach or gastroesophageal junction cancer. Saracatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
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).
SECONDARY OBJECTIVES:
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.
OUTLINE:
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.
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