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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00085878 |
This is a phase I, open-label, dose-escalation study of SB-485232. Subjects will receive SB-485232 administered as subcutaneous injections daily for 14 days. Dose escalation (enrollment into the next cohort) cannot occur until all three subjects have completed the previous cohort; 5 doses will be tested. An additional dosing regimen has been added to evaluate higher doses given twice weekly for 7 weeks. Therefore, the full evaluation period for each patient will extend out to approximately eleven weeks after the first day of SB-485232 dosing.
Condition | Intervention | Phase |
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Solid Tumor Cancer |
Drug: SB-485232 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study |
Official Title: | A Phase I, Dose Escalation Study to Assess the Safety and Pharmacokinetics of SB- 485232 Administered as Daily Subcutaneous Injections in Adult Patients With Solid Tumors |
Enrollment: | 25 |
Study Start Date: | January 2003 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
GSK Investigational Site | |
Santa Monica, California, United States, 90404-2104 | |
United States, Indiana | |
GSK Investigational Site | |
Indianapolis, Indiana, United States, 46202 | |
United States, North Carolina | |
GSK Investigational Site | |
Durham, North Carolina, United States, 27705 | |
United States, Pennsylvania | |
GSK Investigational Site | |
Philadelphia, Pennsylvania, United States, 19111 |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 485232/002, 002 |
Study First Received: | June 16, 2004 |
Last Updated: | October 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00085878 |
Health Authority: | United States: Food and Drug Administration |
IL-18 subcutaneous pharmacokinetics Phase 1 |