A Study of Volociximab in Metastatic Melanoma
- Registration Number
- NCT00369395
- Lead Sponsor
- Abbott
- Brief Summary
This is a Phase 2, multicenter, research study determining the effects of an investigational drug called volociximab in metastatic melanoma.
The purpose of the study is to compare the clinical benefit and safety of volociximab. Pharmacokinetics and mechanism of action will also be evaluated.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 19
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Volociximab volociximab Volociximab 15 mg/kg
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) rate at the Week 8 visit, defined as the number of subjects who have not progressed by the Week 8 visit 8 weeks intervals
- Secondary Outcome Measures
Name Time Method Pharmacokinetics of volociximab Every infusion and follow up visit Assess safety by recording and evaluating adverse events (AEs); changes in vital signs, hematology, blood chemistry, and urinalysis parameters; and anti-volociximab antibody formation Throught study and follow up period,approx. 15 months
Trial Locations
- Locations (7)
Site Reference ID/Investigator# 70376
🇺🇸Boston, Massachusetts, United States
Site Reference ID/Investigator# 70356
🇺🇸La Jolla, California, United States
Site Reference ID/Investigator# 70375
🇺🇸Aurora, Colorado, United States
Site Reference ID/Investigator# 70357
🇺🇸Scottsdale, Arizona, United States
Site Reference ID/Investigator# 70359
🇺🇸St. Louis, Missouri, United States
Site Reference ID/Investigator# 70377
🇺🇸Dallas, Texas, United States
Site Reference ID/Investigator# 70380
🇺🇸Greenville, South Carolina, United States