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

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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