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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00297258 |
The purpose of this study is to evaluate the activity and tolerability of GW786034 in subjects with advanced and/or metastatic soft tissue sarcoma who have relapsed following standard therapies or for whom no standard therapy exists and to characterize the pharmacokinetics of GW786034 in this subject population.
Condition | Intervention | Phase |
---|---|---|
Sarcoma Leiomyosarcoma Adipocytic Tumors Synovial Sarcoma |
Drug: GW786034 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II Study of GW786034 in Patients With Relapsed or Refractory Soft Tissue Sarcoma |
Estimated Enrollment: | 148 |
Study Start Date: | November 2005 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Belgium | |
GSK Investigational Site | |
Bruxelles, Belgium, 1000 | |
GSK Investigational Site | |
Leuven, Belgium, 3000 | |
France | |
GSK Investigational Site | |
Lyon cedex 03, France, 69437 | |
GSK Investigational Site | |
Paris Cedex 05, France, 75248 | |
GSK Investigational Site | |
Villejuif, France, 94805 | |
GSK Investigational Site | |
Marseille, France, 13385 | |
Hungary | |
GSK Investigational Site | |
Budapest, Hungary, 01135 | |
Netherlands | |
GSK Investigational Site | |
Rotterdam, Netherlands, 3075 EA | |
GSK Investigational Site | |
GRONINGEN, Netherlands, 9713 GZ | |
GSK Investigational Site | |
Leiden, Netherlands, 2300 RC | |
United Kingdom | |
GSK Investigational Site | |
Glasgow, United Kingdom, G11 6NT | |
GSK Investigational Site | |
London, United Kingdom, SW3 6JJ | |
GSK Investigational Site | |
Sheffield, United Kingdom, S10 2SJ | |
United Kingdom, Lancashire | |
GSK Investigational Site | |
Manchester, Lancashire, United Kingdom, M20 4BX | |
United Kingdom, Northumberland | |
GSK Investigational Site | |
Newcastle Upon Tyne, Northumberland, United Kingdom, NE4 6BE |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | VEG20002, EORTC-62043, EUDRACT-2004-004 |
Study First Received: | February 24, 2006 |
Last Updated: | October 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00297258 |
Health Authority: | European Union: European Medicines Agency |
Pazopanib(GW786034) Sarcoma Phase II |
Sarcoma, Synovial Neoplasms, Connective and Soft Tissue Leiomyosarcoma Synovial sarcoma |
Malignant mesenchymal tumor Sarcoma Soft tissue sarcomas |
Neoplasms, Muscle Tissue Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue |