Dasatinib in Resectable Malignant Pleural Mesothelioma
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|ClinicalTrials.gov Identifier: NCT00652574|
Recruitment Status : Unknown
Verified September 2018 by M.D. Anderson Cancer Center.
Recruitment status was: Active, not recruiting
First Posted : April 3, 2008
Last Update Posted : September 27, 2018
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.
This research study is financially supported by the United States Department of Defense.
|Condition or disease||Intervention/treatment||Phase|
|Malignant Pleural Mesothelioma||Drug: Dasatinib||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Trial of Induction Dasatinib Therapy in Patients With Resectable Malignant Pleural Mesothelioma|
|Actual Study Start Date :||March 2008|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||March 2019|
Dasatinib = BMS-354825, Sprycel
70 mg by mouth twice daily x 28 days, for up to 2 years after surgery.
- Modulation of biomarker p-Src Tyr419 expression [ Time Frame: Weekly during treatment followed by 5-6 core biopsies during surgery. ]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. ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|