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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):
Formalin fixed paraffin embedded tumor blocks and representative H/E (hematoxylin/eosin) slides must be available for histological central review.
Histological central review is not required before treatment start but is mandatory within 10 days of registration. Local histopathological diagnosis will be accepted for entry into the study.
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 History of Changes |
Health Authority: | European Union: European Medicines Agency |
Neoplasms, Connective and Soft Tissue Soft Tissue Sarcomas Malignant Mesenchymal Tumor Sarcoma |
Neoplasms, Connective and Soft Tissue Neoplasms Neoplasms by Histologic Type Sarcoma |