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
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
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 Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal |
Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas |
ClinicalTrials.gov processed this record on March 02, 2015