Angiopoietin-2 (Ang-2) is a protein in the body which destabilizes blood vessels and is important in stimulating tumor blood vessels. There is evidence suggesting that Ang-2 may be important for the growth and progression of Glioblastoma multiforme (GBM). PF- 04856884 (CVX-060) is a compound which binds Ang-2 and prevents its activity. The hypothesis is that PF-04856884 will be safe and effective in patients with recurrent Glioblastoma multiforme (GBM).
Notification of study being cancelled resulted in update in overall status change from "not yet recruiting" to "withdrawn."
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
PF-04856884 at a dose of 15 mg/kg/week
PF-04856884 at a dose of 15 mg/kg/week
Progression free survival rate at Month 6 (PFS6) defined as the patient progression free status at Month 6.
Time frame: 1 year
Corticosteroid doses at baseline and on-study
Time frame: 4 months
Overall Response Rate (ORR)
Time frame: 2 years
PFS defined as the time from 1st dose of study drug to the 1st documentation of disease progression or death from any cause, whichever comes first.
Time frame: 2 years
Time to death is defined as the time from first study drug to death due to any cause.
Time frame: 2 years
Overall survival (OS) defined as the time from first dose of study drug to death due to any cause.
Time frame: 2 years
OS6 defined as the patient survival status at Month 6. The OS6 rate will be obtained as a Kaplan-Meier estimate of the time to death at Month 6.
Time frame: 2 years
Immunogenicity determined by measuring anti-PF-04856884 antibodies following therapy
Time frame: 4 months
Dynamic Contrast Enhanced Magnetic Resonance Imaging [DCE-MRI] endpoints to include changes from baseline volume transfer coefficient [Ktrans] and/or the initial area under the contrast agent concentration-time curve [IAUC] or Ki following therapy
Time frame: 4 months
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