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Sponsored by: |
Eisai Limited |
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Information provided by: | Eisai Medical Research Inc. |
ClinicalTrials.gov Identifier: | NCT00413192 |
The purpose of this study is to evaluate the therapeutic activity and safety of E7389 in patients with advanced/metastatic soft tissue sarcoma who have failed standard chemotherapy.
Condition | Intervention | Phase |
---|---|---|
Soft Tissue Sarcoma |
Drug: E7389 |
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 E7389 Administered as an IV Bolus Infusion Day 1 and Day 8 Every 3 Weeks in Pre-Treated Patients With Advanced and/or Metastatic Soft Tissue Sarcoma |
Estimated Enrollment: | 148 |
Study Start Date: | January 2007 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: E7389
1.4 mg/m^2 administered as an intravenous (I.V.) bolus infusion on Days 1 and 8 of every 21 days.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Histologically proven advanced and/or metastatic malignant soft tissue sarcoma of high or intermediate grade, and of one of the following histologies (World Health Organization (WHO) classification 2002):
Exclusion Criteria:
Contact: Eisai Limited | +44 (0)20 8600 1400 |
Belgium | |
Recruiting | |
Brussels, Belgium, BE 1000 | |
Recruiting | |
Leuven, Belgium, BE 3000 | |
Denmark | |
Recruiting | |
Aarhus, Denmark, DK 8000 | |
Recruiting | |
Herlev, Denmark, DK 2730 | |
France | |
Recruiting | |
Lyon, France, 69008 | |
Recruiting | |
Bordeaux, France, 33076 | |
Recruiting | |
Marseille, France, 13385 | |
Recruiting | |
Villejuif, France, 94805 | |
Germany | |
Recruiting | |
Essen, Germany, DE 45122 | |
Recruiting | |
Hannover, Germany, DE 30625 | |
Recruiting | |
Bad Saarow, Germany, 15526 | |
Recruiting | |
Dresden, Germany, DE 01307 | |
Recruiting | |
Tuebingen, Germany, DE 72076 | |
Recruiting | |
Mannheim, Germany, DE 68135 | |
Poland | |
Recruiting | |
Warsaw, Poland, 02 781 |
Study Director: | Jantien Wanders, MD | Eisai Limited |
Responsible Party: | Eisai Limited ( Jantien Wanders MD, Study Director ) |
Study ID Numbers: | E7389-E044-207 |
Study First Received: | December 15, 2006 |
Last Updated: | December 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00413192 |
Health Authority: | European Union: European Medicines Agency |
Neoplasms, Connective and Soft Tissue Malignant mesenchymal tumor Sarcoma Soft tissue sarcomas |
Neoplasms Neoplasms by Histologic Type |