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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
Volociximab, 15 mg/kg, IV infusion once a week for 8 weeks. Subjects who achieved SD or better at Day 50 ± 2 days (Week 8) were eligible to continue receiving weekly infusions of volociximab until disease progression.
Site Reference ID/Investigator# 70357
Scottsdale, Arizona, 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# 70376
Boston, Massachusetts, United States
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
Time frame: 8 weeks intervals
Pharmacokinetics of volociximab
Time frame: 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
Time frame: Throught study and follow up period,approx. 15 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Site Reference ID/Investigator# 70359
St Louis, Missouri, United States
Site Reference ID/Investigator# 70380
Greenville, South Carolina, United States
Site Reference ID/Investigator# 70377
Dallas, Texas, United States