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Sponsored by: |
Istituto Clinico Humanitas |
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Information provided by: | Istituto Clinico Humanitas |
ClinicalTrials.gov Identifier: | NCT00407459 |
The primary objective is to assess antitumor activity of the combination of bevacizumab, pemetrexed and carboplatin, in terms of time to progression.
Condition | Intervention | Phase |
---|---|---|
Mesothelioma |
Drug: Bevacizumab, Pemetrexed, Carboplatin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II Study of the Combination of Bevacizumab Plus Pemetrexed and Carboplatin as First-Line Therapy in Patients With Malignant Pleural Mesothelioma |
Estimated Enrollment: | 77 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Secondary endpoints are to evaluate:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Armando Santoro, MD | +39 02 8224 ext 4080 | armando.santoro@humanitas.it |
Contact: Paolo Andrea L Zucali, MD | +39 02 8224 ext 4559 | paolo.zucali@humanitas.it |
Italy, Milan | |
Istituto Clinico Humanitas | Recruiting |
Rozzano, Milan, Italy, 20089 | |
Contact: Armando Santoro, MD +39 02 8224 ext 4080 armando.santoro@humanitas.it | |
Contact: Paolo Andrea L Zucali, MD +39 02 8224 ext 4559 paolo.zucali@humanitas.it |
Principal Investigator: | Armando Santoro, MD | Istituto Clinico Humanitas |
Responsible Party: | Istituto Clinico Humanitas ( Dr. Armando Santoro ) |
Study ID Numbers: | ONC-2006-003, EUDRACT 2006-004429-27 |
Study First Received: | December 4, 2006 |
Last Updated: | December 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00407459 |
Health Authority: | Italy: Ministry of Health |
Folic Acid Pemetrexed Mesothelioma Carboplatin |
Bevacizumab Adenoma Neoplasms, Glandular and Epithelial |
Antimetabolites Neoplasms by Histologic Type Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Neoplasms, Mesothelial Antineoplastic Agents Growth Substances Physiological Effects of Drugs |
Enzyme Inhibitors Folic Acid Antagonists Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents |