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A Phase II, Multi-center, Open-label, Randomized Study Evaluating the Anti-tumor Activity of SB-485232, rhIL-18, Administered as Five Daily Intravenous Infusions Every 28 Days in Subjects With Previously Untreated Metastatic Melanoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Metastatic Melanoma

Thank you

Trial Information

A Phase II, Multi-center, Open-label, Randomized Study Evaluating the Anti-tumor Activity of SB-485232, rhIL-18, Administered as Five Daily Intravenous Infusions Every 28 Days in Subjects With Previously Untreated Metastatic Melanoma

Inclusion Criteria


Inclusion criteria:

- Patients must have melanoma that has spread beyond the original location and has not
yet been treated.

- Tissue from the spreading melanoma should have been tested to confirm it is melanoma.

Exclusion criteria:

- Patients having hepatitis or HIV infection.

- Taking corticosteroids.

- Patients with the primary site being occular melanoma or patients with melanoma of
the brain.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate of tumor.

Principal Investigator

GSK Clinical Trials, MD

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Food and Drug Administration

Study ID:

SB-485232/006

NCT ID:

NCT00107718

Start Date:

November 2004

Completion Date:

May 2006

Related Keywords:

  • Metastatic Melanoma
  • IL-18
  • Phase 2
  • melanoma
  • treatment naive
  • Melanoma

Name

Location

GSK Investigational SiteBakersfield, California  93309
GSK Investigational SiteGainesville, Florida  32610
GSK Investigational SiteIndianapolis, Indiana  46260
GSK Investigational SiteAkron, Ohio  44304
GSK Investigational SitePark Ridge, Illinois  60068
GSK Investigational SiteBaltimore, Maryland  21201
GSK Investigational SitePittsburgh, Pennsylvania  15213
GSK Investigational SiteNew York, New York  10021
GSK Investigational SiteHartford, Connecticut  06106