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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00500058 |
Purpose
The purpose is to identify a dose of SB-485232 which is safe, tolerable and effective when used in combination with Rituximab in patients with non-Hodgkin's lymphoma (NHL). This study will use a standard treatment regimen of Rituximab in combination with rising doses of SB-485232. The dose selected from this study will be used in a future studies.
| Condition | Intervention | Phase |
|---|---|---|
|
B-Cell Lymphomas Lymphoma, Non-Hodgkin |
Drug: interleukin-18, Rituxan, Rituximab |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I, Dose-Escalation Study to Assess the Safety and Biological Activity of Recombinant Human Interleukin-18 (SB- 485232) Administered by Intravenous Infusion in Combination With Rituximab in Adult Patients With B Cell Non-Hodgkin's Lymphoma" |
| Enrollment: | 24 |
| Study Start Date: | July 2007 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
The subject is likely to maintain good venous blood access for PK and PD sampling throughout the study.
A female is eligible to enter and participate in the study if she is of:
a. non-childbearing potential (i.e., physiologically incapable of becoming pregnant) including any female who:
any intrauterine device (IUD) with a documented failure rate of less than
1% per year.
Exclusion Criteria:
Contacts and Locations| United States, Illinois | |
| GSK Investigational Site | |
| Chicago, Illinois, United States, 60637 | |
| United States, Indiana | |
| GSK Investigational Site | |
| Indianapolis, Indiana, United States, 46202 | |
| Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
More Information
| Responsible Party: | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure |
| ClinicalTrials.gov Identifier: | NCT00500058 History of Changes |
| Other Study ID Numbers: | ILI105618 |
| Study First Received: | July 10, 2007 |
| Last Updated: | March 10, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Rituximab, oncology IL-18, combination study, cytokine, |
|
Lymphoma Lymphoma, Non-Hodgkin Lymphoma, B-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Rituximab Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents |