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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborators: |
Bristol-Myers Squibb Department of Defense |
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00652574 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Malignant Pleural Mesothelioma |
Drug: Dasatinib |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Phase I Trial of Induction Dasatinib Therapy in Patients With Resectable Malignant Pleural Mesothelioma |
| Estimated Enrollment: | 24 |
| Study Start Date: | March 2008 |
| Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Dasatinib: Experimental
Dasatinib = BMS-354825, Sprycel
|
Drug: Dasatinib
70 mg by mouth twice daily x 28 days, for up to 2 years after surgery.
|
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| Contact: Anne S. Tsao, MD | 713-792-6363 | |
| Contact: James Gil, RN | 713-745-6766 |
| United States, Texas | |
| U.T.M.D. Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Anne S. Tsao, MD | |
| Principal Investigator: | Anne S. Tsao, MD | U.T.M.D. Anderson Cancer Center |
More Information
| Responsible Party: | U.T.M.D. Anderson Cancer Center ( Anne S. Tsao, MD/Assistant Professor ) |
| Study ID Numbers: | 2006-0935 |
| Study First Received: | March 27, 2008 |
| Last Updated: | June 30, 2009 |
| ClinicalTrials.gov Identifier: | NCT00652574 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Malignant Pleural Mesothelioma Dasatinib BMS-354825 Sprycel MPM |
|
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Neoplasms, Mesothelial Dasatinib Mesothelioma |
Enzyme Inhibitors Protein Kinase Inhibitors Adenoma Pharmacologic Actions Neoplasms, Glandular and Epithelial |