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Sponsored by: |
Gruppo Italiano MEsotelioma |
Information provided by: | Gruppo Italiano MEsotelioma |
ClinicalTrials.gov Identifier: | NCT00551252 |
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 |
ChemIDplus related topics: | 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 |
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:
Contact: Camillo Porta, MD | +39-0382-501355 | c.porta@smatteo.pv.it |
Italy | |||||
Medical Oncology, IRCCS San Matteo University Hospital Foundation | Not yet recruiting | ||||
Pavia, Italy, 27100 | |||||
Principal Investigator: Camillo Porta, MD |
Gruppo Italiano MEsotelioma |
Principal Investigator: | Camillo Porta, MD | Medical Oncology, IRCCS San Matteo University Hospital Foundation, pavia, Italy |
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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