Anti-Tumor Activity Of SB-485232 In Patients With Previously Untreated Metastatic Melanoma
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00107718
First received: April 7, 2005
Last updated: October 1, 2010
Last verified: October 2010
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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
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 June 18, 2013