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Phase II Study of the c-SRC Inhibitor AZD0530 After Four Cycles of Cytoreductive Chemotherapy for Patients With Extensive Stage Small Cell Lung Carcinoma
AZD0530 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This phase II study is studying how well giving AZD0530 works in treating patients with extensive-stage small cell lung cancer.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
North Central Cancer Treatment Group
Rochester, Minnesota, United States
Start Date
November 1, 2007
Primary Completion Date
November 1, 2008
Completion Date
May 1, 2013
Last Updated
December 7, 2017
23
ACTUAL participants
saracatinib
DRUG
Lead Sponsor
National Cancer Institute (NCI)
NCT05672108
NCT07037758
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06651658