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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00085904 |
SB-485232 will be administered as five daily intravenous (IV) infusions repeated every 28 days in adult subjects with advanced solid tumors or lymphomas. Subjects may receive up to 6 cycles of treatment unless progressive disease or unacceptable toxicity is noted. Three dose levels of drug will be investigated. Safety evaluations, including blood sampling for various laboratory tests, will be conducted. Additional blood samples will also be taken to measure the amount of drug in the body at specific times.
Condition | Intervention | Phase |
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Solid Tumor Cancer Lymphoma |
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 Five Daily Intravenous Infusions Repeated Every 28 Days in Adult Patients With Solid Tumors and Lymphomas |
Enrollment: | 12 |
Study Start Date: | April 2004 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion Criteria:
United States, Indiana | |
GSK Investigational Site | |
Indianapolis, Indiana, United States, 46202 | |
United States, Massachusetts | |
GSK Investigational Site | |
Boston, Massachusetts, United States, 02215 | |
United States, Pennsylvania | |
GSK Investigational Site | |
Pittsburgh, Pennsylvania, United States, 15213-2584 |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 485232/003, 003 |
Study First Received: | June 16, 2004 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00085904 |
Health Authority: | United States: Food and Drug Administration |
Advanced cancer IL-18 repeat dosing |
Phase 1 pharmacokinetics oncology |
Lymphatic Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Lymphoma |
Neoplasms Neoplasms by Histologic Type Immune System Diseases |