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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00478725 |
To study the absorption, distribution, metabolism and excretion of GSK786034, and the absorption of a single IV dose of GSK786034
Condition | Intervention | Phase |
---|---|---|
Cancer |
Drug: GSK786034 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study |
Official Title: | An Open-Label, Two-Part Study to Characterize the Pharmacokinetics of a Single Intravenous Dose of Pazopanib (GW786034) and the Absorption, Distribution, Metabolism and Elimination of a Single Oral [14C] Labeled Dose of Pazopanib in Subjects With Solid Tumor Malignancies |
Estimated Enrollment: | 10 |
Study Start Date: | July 2007 |
Study Completion Date: | July 2008 |
Primary Completion Date: | July 2008 (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:
A male subject with a female partner of childbearing potential is eligible to enter and participate in this study if he:
A female subject is eligible to enter and participate in this study if she is of:
Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who has had:
Childbearing potential and has a negative serum pregnancy test within 2 weeks prior to the first dose of study treatment, preferably as close to the first dose as possible, and agrees to use adequate contraception. GSK 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:
United States, Minnesota | |
GSK Investigational Site | |
Minneapolis, Minnesota, United States, 55404 | |
United States, Tennessee | |
GSK Investigational Site | |
Nashville, Tennessee, United States, 37203 |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | VEG10004 |
Study First Received: | May 24, 2007 |
Last Updated: | October 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00478725 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Advanced Cancer Metastatic Cancer |
Neoplasm Metastasis |