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Home > Protocol Summaries: Compounds > iboctadekin > Protocol Summary for SB-485232/006

Protocol Summary for SB-485232/006

Protocol Summary
Protocol Id: SB-485232/006
Secondary Ids:
  • 006
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
Phase: Phase 2
Acronym:
FDA Regulated Intervention?:
Section 801 Clinical Trial?:
Delayed Posting:
IND/IDE Protocol?: yes
IND/IDE Grantor: CBER
IND/IDE Number: 10125
IND/IDE Serial Number: 0038
Has Expanded Access?: None
Study Type: interventional
Oversight Authority:
  • United States: Food and Drug Administration
Collaborators:
Brief 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.
Detailed Description:
Record Verification Date: September 2009
Status: Completed
Why Study Stopped:
Study Start Date: November 2004
Study Completion Date:
Study Completion Date Type: None
Primary Completion Date:
Primary Completion Date Type:
Primary Purpose: Treatment
Allocation: Randomized
Masking: Open Label
Masked Subject:
Masked Caregiver:
Masked Investigator:
Masked Assessor:
Study Design (Assignment): Parallel Assignment
Study Classification (Endpoint): Safety/Efficacy Study
Primary Outcomes:
  • Overall response rate of tumor.
Secondary Outcomes:
  • Progression free survival. Response duration. Time to response. Safety and tolerability. The immune response to SB-485232.
Conditions:
  • Melanoma
Keywords:
  • IL-18
  • Phase 2
  • melanoma
  • treatment naive
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 18 Years
Maximum Age: N/A N/A
Enrollment: 64
Enrollment Type:
Healthy Volunteers?: no
Central Contact: US GSK Clinical Trials Call Center
Central Contact Phone: 877-379-3718
Central Contact Email: GSKClinicalSupportHD@gsk.com
Backup Central Contact: EU GSK Clinical Trials Call Center
Backup Central Contact Phone: +44 (0) 20 8990 4466
Backup Central Contact Email: GSKClinicalSupportHD@gsk.com
Overall Study Official: GSK Clinical Trials
Overall Study Official Affiliation: GlaxoSmithKline
Overall Study Official Role: Study Director
Responsible Party Name/Official Title: Cheri Hudson; Clinical Disclosure Advisor
Responsible Party Organization: GSK Clinical Disclosure
Location and Contact Information: Click to view location information