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| Sponsored by: |
Gruppo Italiano MEsotelioma |
| Information provided by: | Gruppo Italiano MEsotelioma |
| ClinicalTrials.gov Identifier: | NCT00551252 |
Purpose
The purpose of this study is to evaluate the antitumor activity of a combination of Imatinib mesylate and Gemcitabine in patients with unresectable malignant mesothelioma expressing either PDGFR-beta or C-kit
| Condition | Intervention | Phase |
|
Mesothelioma |
Drug: Imatinib mesylate plus Gemcitabine |
Phase II |
| MedlinePlus related topics: | Mesothelioma |
| Drug Information available for: | Gemcitabine hydrochloride Gemcitabine Imatinib Imatinib mesylate |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
| Official Title: | A Phase II Study of the Association of Glivec® (Imatinib Mesylate, Formerly Known as STI 571) Plus Gemzar® (Gemcitabine) in Patients With Unresectable, Refractory, Malignant Mesothelioma Expressing Either PDGFR-Beta or C-Kit |
| Estimated Enrollment: | 56 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | December 2009 |
| Arms | Assigned Interventions |
| I: Experimental |
Drug: Imatinib mesylate plus Gemcitabine
Imatinib (400 mg daily) + Gemcitabine (500 mg/sqm, days 1 and 8 every 21 days) for a maximum of 6 cycles
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Show Detailed Description |
Eligibility
| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Any of the following abnormal baseline hematological values:
Contacts and Locations| Contact: Camillo Porta, MD | +39-0382-501355 | c.porta@smatteo.pv.it |
| Italy | |||||
| Medical Oncology, IRCCS San Matteo University Hospital Foundation | |||||
| Pavia, Italy, 27100 | |||||
| Gruppo Italiano MEsotelioma |
| Principal Investigator: | Camillo Porta, MD | Medical Oncology, IRCCS San Matteo University Hospital Foundation, pavia, Italy |
More Information
Italian Mesothelioma Group Homepage 
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| Study ID Numbers: | GIMe/01/06 |
| First Received: | October 29, 2007 |
| Last Updated: | October 29, 2007 |
| ClinicalTrials.gov Identifier: | NCT00551252 |
| Health Authority: | Italy: Ethics Committee |
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