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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborators: |
Bristol-Myers Squibb Department of Defense |
| Information provided by (Responsible Party): | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00652574 |
Purpose
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.
Objectives:
Primary Objectives:
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:
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Malignant Pleural Mesothelioma |
Drug: Dasatinib |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized 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 |
| Estimated Enrollment: | 60 |
| Study Start Date: | March 2008 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Dasatinib
Dasatinib = BMS-354825, Sprycel
|
Drug: Dasatinib
70 mg by mouth twice daily x 28 days, for up to 2 years after surgery.
Other Names:
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Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| UT MD . Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Anne S. Tsao, MD | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00652574 History of Changes |
| Other Study ID Numbers: | 2006-0935 |
| Study First Received: | March 27, 2008 |
| Last Updated: | January 26, 2012 |
| Health Authority: | United States: Institutional Review Board |
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Malignant Pleural Mesothelioma Dasatinib BMS-354825 Sprycel MPM |
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Mesothelioma Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Mesothelial |
Dasatinib Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |