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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00350727 |
This study is being conducted to characterize the safety/tolerability of pazopanib and lapatinib when administered in combination with enzyme-inducing anticonvulsants in patients with recurrent Grade III or IV malignant gliomas.
Condition | Intervention | Phase |
---|---|---|
Glioma Malignant Disease |
Drug: pazopanib Drug: lapatinib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study |
Official Title: | Phase I and II, Open-Label, Multi-Center Trials of Pazopanib in Combination With Lapatinib in Adult Patients With Relapsed Malignant Glioma |
Estimated Enrollment: | 105 |
Study Start Date: | December 2006 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Phase I
Phase I and II
A woman is eligible to enter and participate in the study if she is of:
- Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who:
Is post-menopausal (total cessation of menses for at least 1 year)
- Childbearing potential, has a negative serum pregnancy test at screening, and agrees to use adequate contraception. Acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follows:
Exclusion criteria:
Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
United States, Alabama | |
GSK Investigational Site | Completed |
Birmingham, Alabama, United States, 35294 | |
United States, California | |
GSK Investigational Site | Withdrawn |
San Francisco, California, United States, 94115 | |
United States, Florida | |
GSK Investigational Site | Withdrawn |
Tampa, Florida, United States, 33612-9497 | |
United States, Georgia | |
GSK Investigational Site | Withdrawn |
Atlanta, Georgia, United States, 30322 | |
United States, Illinois | |
GSK Investigational Site | Recruiting |
Chicago, Illinois, United States, 60611 | |
United States, Massachusetts | |
GSK Investigational Site | Completed |
Boston, Massachusetts, United States, 02115 | |
United States, Michigan | |
GSK Investigational Site | Recruiting |
Detroit, Michigan, United States, 48202 | |
United States, New York | |
GSK Investigational Site | Completed |
New York, New York, United States, 10032 | |
United States, North Carolina | |
GSK Investigational Site | Recruiting |
Durham, North Carolina, United States, 27710 | |
United States, Ohio | |
GSK Investigational Site | Completed |
Cleveland, Ohio, United States, 44195 | |
United States, Pennsylvania | |
GSK Investigational Site | Withdrawn |
Philadelphia, Pennsylvania, United States, 19104 | |
United States, Texas | |
GSK Investigational Site | Recruiting |
Houston, Texas, United States, 77030-4009 | |
India | |
GSK Investigational Site | Withdrawn |
Mumbai, India, 400012 | |
United Kingdom, Surrey | |
GSK Investigational Site | Recruiting |
Sutton, Surrey, United Kingdom, SM2 5PT |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | VEG102857 |
Study First Received: | July 10, 2006 |
Last Updated: | October 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00350727 |
Health Authority: | United States: Food and Drug Administration; European Union: European Medicines Agency; United States: Food and Drug Administration |
Pazopanib glioblastoma lapatinib relapsed |
Neuroectodermal Tumors Glioblastoma Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Lapatinib Glioma Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Neoplasms, Nerve Tissue Enzyme Inhibitors Neoplasms, Neuroepithelial Protein Kinase Inhibitors Pharmacologic Actions |