A Phase I, Dose-Escalation Study to Assess the Safety and Biological Activity of Recombinant Human Interleukin-18

Part of paid clinical trials in Chicago, Illinois.

Sponsor
GlaxoSmithKline
Study ID
NCT00500058
Phase
PHASE1
Status
Completed

Conditions

  • Lymphoma, Non-Hodgkin

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SB-485232 — DRUG
    SB-485232 for injection, 7 mg/vial, will be available as a lyophilized cake. It will be reconstituted with 1.4 mL of water for injection. Each vial of this drug product is a clear, colorless solution containing 5 mg/mL of SB-485232.
  • Rituximab — DRUG
    Rituximab 375 mg/m\^2 will be administered by IV infusion.

Study Details

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.

Key Dates

First listed
Jul 12, 2007
Start date
Jul 31, 2007
Status verified
Jul 2017
Primary completion
Mar 4, 2010
Completion
Mar 4, 2010

Study Design

Enrollment
24 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: SB-485232+Rituximab
    Rituximab 375 milligrams per square meter (mg/m\^2) will be administered to subjects with CD20+ B cell lymphoma by intravenous (IV) infusion once a week for four consecutive weeks on Day 1 of Weeks 1 to 4. SB-485232 will be administered by IV infusion over a 2 hour period, at doses ranging from 1 microgram (μg)/kilogram (kg) to 100 μg/kg. SB-485232 will be given once a week for 12 consecutive weeks on Day 2 of Weeks 1 to 4 and Day 2 (± 1 day) of Weeks 5 to 12. SB-485232 will be infused at least 24 hours after the Rituximab infusion was started.

Primary Outcome Measure

safety/tolerability of combination treatment for 4 weeks safety/tolerability of SB-485232 for additional 8 weeks [ Time Frame: 12 weeks ]

Locations (2)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteChicagoIllinois60637-
GSK Investigational SiteIndianapolisIndiana46202-

Find similar trials in Chicago, IL

By research site
GSK Investigational Site· Chicago, ILGSK Investigational Site· Indianapolis, IN

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