Anti-Tumor Activity Of SB-485232 In Patients With Previously Untreated Metastatic Melanoma

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00107718
First received: April 7, 2005
Last updated: October 1, 2010
Last verified: October 2010
  Purpose

This Phase II study is designed to evaluate the anti-tumor activity of three dose groups of SB-485232 (0.01, 0.1, and 1.0 mg/kg/day) administered intravenously as a single agent in subjects with previously untreated metastatic melanoma.


Condition Intervention Phase
Metastatic Melanoma
Drug: SB-485232
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Overall response rate of tumor.

Secondary Outcome Measures:
  • Progression free survival. Response duration. Time to response. Safety and tolerability. The immune response to SB-485232.

Estimated Enrollment: 64
Study Start Date: November 2004
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: SB-485232
    Other Name: SB-485232
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00107718

Locations
United States, California
GSK Investigational Site
Los Angeles, California, United States, 90089
GSK Investigational Site
San Francisco, California, United States, 94115
GSK Investigational Site
Santa Monica, California, United States, 90404-2104
United States, Connecticut
GSK Investigational Site
New Haven, Connecticut, United States, 06520
United States, Florida
GSK Investigational Site
Jacksonville, Florida, United States, 32209
GSK Investigational Site
Miami Beach, Florida, United States, 33140
United States, Illinois
GSK Investigational Site
Chicago, Illinois, United States, 60637
United States, Indiana
GSK Investigational Site
Indianapolis, Indiana, United States, 46202
United States, Maryland
GSK Investigational Site
Lutherville Timonium, Maryland, United States, 21093
United States, New York
GSK Investigational Site
New York, New York, United States, 10016
United States, Ohio
GSK Investigational Site
Toledo, Ohio, United States, 43614-5809
United States, Pennsylvania
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15213-2584
Australia, New South Wales
GSK Investigational Site
Waratah, New South Wales, Australia, 2298
GSK Investigational Site
Westmead, New South Wales, Australia, 2145
Australia, Queensland
GSK Investigational Site
Douglas, Queensland, Australia, 4814
GSK Investigational Site
South Brisbane, Queensland, Australia, 4101
GSK Investigational Site
Woolloongabba, Queensland, Australia, 4102
Australia, Tasmania
GSK Investigational Site
Hobart, Tasmania, Australia, 7000
Australia, Victoria
GSK Investigational Site
East Melbourne, Victoria, Australia, 3002
Australia, Western Australia
GSK Investigational Site
Nedlands, Western Australia, Australia, 6009
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00107718     History of Changes
Other Study ID Numbers: SB-485232/006, 006
Study First Received: April 7, 2005
Last Updated: October 1, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
IL-18
Phase 2
melanoma
treatment naive

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on August 28, 2014