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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00597116 |
A clinical study to assess if a new investigational drug is effective in treating malignant mesothelioma, compared to a chemotherapy treatment (Navelbine®). In this study the patients will be assigned by chance to receive either the new drug or a chemotherapy treatment (Navelbine®). Treatment will continue as long as the cancer does not worsen and the patient wishes to continue in the study. The study will recruit approximately 66 patients.
Condition | Intervention | Phase |
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Mesothelioma |
Drug: Vinorelbine Drug: Vandetanib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomized Phase II Trial To Evaluate The Efficacy And Safety Of Vandetanib (ZD6474, ZACTIMA ™) Versus Vinorelbine In Patients With Inoperable Or Relapsed Malignant Mesothelioma. |
Estimated Enrollment: | 66 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Vinorelbine
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Drug: Vinorelbine |
2: Experimental
Vandetanib
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Drug: Vandetanib
once daily oral dose
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: AstraZeneca Switzerland Clinical Study Information | +0041 41 725 76 14 |
Germany | |
Research Site | Recruiting |
Heidelberg, Germany | |
Research Site | Recruiting |
Essen, Germany | |
Research Site | Recruiting |
Hamburg, Germany | |
Research Site | Recruiting |
Halle-Dolau, Germany | |
Switzerland | |
Research Site | Recruiting |
Zurich, Switzerland | |
Research Site | Recruiting |
Chur, Switzerland |
Principal Investigator: | Rolf Stahel | University of Zurich |
Study Director: | Madeleine Billeter | AstraZeneca |
Study Chair: | Verena Renggli, MSc | AstraZeneca |
Responsible Party: | AstraZeneca ( Peter Langmuir - Medical Science Director ) |
Study ID Numbers: | D4200C00075, EUDRACT Number 2007-003633-16 |
Study First Received: | January 9, 2008 |
Last Updated: | April 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00597116 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices; Switzerland: Swissmedic |
Mesothelioma inoperable relapsed |
Vinorelbine Mesothelioma Adenoma Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Histologic Type Antineoplastic Agents Neoplasms, Mesothelial |
Therapeutic Uses Antineoplastic Agents, Phytogenic Pharmacologic Actions |