A Phase 2 Study of AZD0530 in Patients With Advanced, Recurrent Non-Small Cell Lung Cancer Who Have Previously Received Platinum-Based Combination Chemotherapy
I. Assess the rate of disease control (i.e., lack of disease progression, objective complete
and partial response, and stable disease) in patients with recurrent, stage IIIB or IV
non-small cell lung cancer treated with AZD0530 (saracatinib).
I. Assess the objective response rate (complete and partial response), stable disease rate,
and duration of response or stable disease in patients treated with AZD0530.
II. Assess the progression-free, median, and 6-month overall survival rates in patients
treated with AZD0530.
III. Assess the safety and tolerability of AZD0530 in these patients. IV. 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: This is a multicenter study.
Patients receive saracatinib orally (PO) once daily (QD) on days 1-28. Courses repeat every
28 days in the absence of unacceptable toxicity or disease progression.
Tumor tissue samples are collected at baseline and at 2 weeks after beginning treatment and
are analyzed for c-Src protein expression and activity by immunofluorescence staining.
P-glycoprotein levels and phosphorylation of focal adhesion kinase (FAK), paxillin,
caveolin, and Stat-3 are also measured using tumor tissue samples. Blood samples are also
used to measure levels of VEGF by ELISA.
After completion of study treatment, patients are followed every 4 weeks.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Rate of disease control (freedom from disease progression)
Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible.
University Health Network-Princess Margaret Hospital
United States: Food and Drug Administration