This clinical trial is being conducted to determine tumor response and preliminary safety of a monoclonal antibody that specifically binds to a cell surface receptor (α5β1 integrin) that is required for the establishment of new blood vessels during tumor growth, a process known as angiogenesis.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Volociximab: 10 mg/kg or 15mg/kg every week or every other week (qowk) via IV infusion for up to 104 weeks.
Gemcitabine: Standard chemotherapy regime at 1 g/m2 once per week for 3 weeks via IV infusion, followed by one week with no treatment
Site Reference ID/Investigator# 70538
Pittsburgh, Pennsylvania, United States
Site Reference ID/Investigator# 70537
Nashville, Tennessee, United States
Site Reference ID/Investigator# 70534
Glasgow, United Kingdom
Site Reference ID/Investigator# 70533
Leeds, United Kingdom
The proportion of patients, in each dose cohort, with a confirmed tumor response
Time frame: Any time during the course of the trial (up to 104 weeks)
Duration of progression-free survival
Time frame: During the course of the trial (up to 104 weeks)
Time to disease progression
Time frame: During the course of the trial (up to 104 weeks)
Duration of overall survival
Time frame: During the course of the trial (up to 104 weeks)
To evaluate the safety in of M200 in combination with gemcitabine
Time frame: During the course of the trial (up to 104 weeks)
To evaluate the pharmacokinetics of M200
Time frame: During the course of the trial (up to 104 weeks)
To evaluate the immunogenicity of M200
Time frame: During the course of the trial (up to 104 weeks)
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Site Reference ID/Investigator# 70536
Manchester, United Kingdom
Site Reference ID/Investigator# 70535
Northwood, United Kingdom