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NCT00107718 · ClinicalTrials.gov registry record · Phase 2
Anti-Tumor Activity Of SB-485232 In Patients With Previously Untreated Metastatic Melanoma
A Phase 2 study of Melanoma, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 64
- Enrollment target
- 20
- Study locations
NCT00107718: Completed Phase 2 study of Melanoma, sponsored by GlaxoSmithKline.
NCT00107718 is a Phase 2 study of Melanoma that has completed, run by GlaxoSmithKline. The registered enrollment target is 64 participants, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (91% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00107718, a Phase 2 study of Melanoma, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 64 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
Tumor response rate (RR) is defined as the percentage of participants achieving either a complete or partial response. Response was at least one measurable lesion as defined by response evaluation criteria for solid tumors (RECIST) criteria or a cutaneous or subcutaneous lesion of at least 1 centimeter (cm) in diameter in one dimension. A distinction was drawn between responses that are confirmed at a repeat assessment and those that are not. If there were unconfirmed responses, then a sensitivi
Conditions Studied
Interventions
- DRUG SB-485232
Study Locations (20)
California
- GSK Investigational Site - Los Angeles
- GSK Investigational Site - San Francisco
- GSK Investigational Site - Santa Monica
Queensland
- GSK Investigational Site - Douglas
- GSK Investigational Site - South Brisbane
- GSK Investigational Site - Woolloongabba
Florida
- GSK Investigational Site - Jacksonville
- GSK Investigational Site - Miami Beach
New South Wales
- GSK Investigational Site - Waratah
- GSK Investigational Site - Westmead
Connecticut
- GSK Investigational Site - New Haven
Illinois
- GSK Investigational Site - Chicago
Indiana
- GSK Investigational Site - Indianapolis
Maryland
- GSK Investigational Site - Lutherville-Timonium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2004-11-15 |
| Est. Completion | 2006-05-19 |
| Phase | Phase 2 |
What the finished NCT00107718 record still lists
NCT00107718 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Melanoma appearing as the primary indexed condition, and to 1 intervention - of which SB-485232 is the first listed.
NCT00107718 names 20 study sites across 14 states, led by California, Queensland, Florida.
Frequently Asked Questions
What is clinical trial NCT00107718 about?
NCT00107718 is a clinical study titled "Anti-Tumor Activity Of SB-485232 In Patients With Previously Untreated Metastatic Melanoma". 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.
What is the current status of trial NCT00107718?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 64 participants. The study started on 2004-11-15. Estimated completion is 2006-05-19.
What conditions does trial NCT00107718 study?
This clinical trial studies the following conditions: Melanoma.
What interventions are being tested in trial NCT00107718?
The interventions under investigation include: SB-485232 (DRUG).
Who is sponsoring clinical trial NCT00107718?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00107718 being conducted?
This trial has 20 study locations across California, Connecticut, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00107718's enrollment target sits among peer trials
64 147th of 266 higher than 119 of 266 other Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Melanoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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