Phase II Study of the c-SRC Inhibitor AZD0530 After Four Cycles of Cytoreductive Chemotherapy for Patients With Extensive Stage Small Cell Lung Carcinoma
PRIMARY OBJECTIVES:
I. To determine the 12-week progression-free survival rate of patients with extensive stage
small cell lung cancer treated with AZD0530.
SECONDARY OBJECTIVES:
I. To determine the response rate in patients treated with this drug. II. To determine the
overall survival and time-to-progression in patients treated with this drug.
III. To determine the adverse events of AZD0530 in these patients IV. To determine the
effect of AZD0530 treatment on levels of circulating tumor cells in these patients.
V. To determine potential predictive markers of response in circulating tumor cells after
treatment with this drug.
VI. To evaluate the rate of tumor marker (i.e., circulating tumor cells) stabilization in
patients treated with this drug.
TERTIARY OBJECTIVES:
I. To determine the effect of AZD0530 treatment on levels of circulating tumor cells.
II. To determine potential predictive markers of response in circulating tumor cells after
treatment with this drug.
III. To evaluate the rate of tumor marker (i.e., circulating tumor cells) stabilization in
patients treated with this drug.
OUTLINE: Patients receive oral AZD0530 once daily for up to 2 years in the absence of
disease progression or unacceptable toxicity. Blood samples are obtained at baseline and
periodically during study to determine levels of circulating tumor cells for defined
translational studies.
After completion of study therapy, patients are followed periodically for up to 2 years.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival rate at 12 weeks
The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients, unless we have a lost to follow-up issue. All patients meeting the eligibility criteria who have signed a consent form, begun AZD treatment, and are not lost to follow-up before 12 weeks, will be considered evaluable for the 12-week progression-free survival (PFS) rate.
12 weeks
No
Julian Molina
Principal Investigator
North Central Cancer Treatment Group
United States: Food and Drug Administration
NCI-2012-01831
NCT00528645
November 2007
Name | Location |
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North Central Cancer Treatment Group | Rochester, Minnesota 55905 |