Dasatinib in Resectable Malignant Pleural Mesothelioma
The goal of this clinical research study is to learn how dasatinib affects biomarker levels in patients with malignant pleural mesothelioma that may be able to be removed by surgery. The safety and effectiveness of this drug will also be studied.
The primary objective of this novel phase I trial will be the level of biomarker modulation of p-Src Tyr 419 by induction dasatinib therapy in patients with resectable malignant pleural mesothelioma.
Secondary objectives include overall and progression-free survival, tumor radiographic and pathologic response, and safety-toxicity profiles. Exploratory analyses will include additional biomarker evaluation in pre- and post-treatment tumor specimens, and serum/platelet/pleural effusion biomarker modulation.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Trial of Induction Dasatinib Therapy in Patients With Resectable Malignant Pleural Mesothelioma|
- Modulation of biomarker p-Src Tyr419 expression [ Time Frame: Weekly during treatment followed by 5-6 core biopsies during surgery. ] [ Designated as safety issue: Yes ]McNemar's test used to compare the p-Src Tyr 419 expression before and after dasatinib treatment. The magnitude of modulation tested and quantified via paired-t test and Wilcoxon signed-rank test. For continuous data, paired-t test used for testing the biomarker modulation pre- and post-treatment.
- Progression-free Survival [ Time Frame: 3 Years, or until disease progression. ] [ Designated as safety issue: No ]Kaplan-Meier method used to estimate the distribution of time-to-event-endpoints. Pearson and Spearman's correlation coefficients computed to correlate baseline biomarker values and biomarker modulation with participant's medical demographic variables as well as clinical outcomes.
|Study Start Date:||March 2008|
|Estimated Primary Completion Date:||March 2018 (Final data collection date for primary outcome measure)|
Dasatinib = BMS-354825, Sprycel
70 mg by mouth twice daily x 28 days, for up to 2 years after surgery.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00652574
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Anne S. Tsao, MD||M.D. Anderson Cancer Center|