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Abstract
Purpose
Blogger's Note: stats removed for ease of reading (eg. CI):
Progression-free survival (the primary endpoint) in the phase 2 study was 7.2 months in the AMG 386 10 mg/kg QW dose group and 5.7 months in the 3 mg/kg group, compared with 4.6 months for placebo. Results from Tarone’s test and dose-exposure analyses suggested a dose–response effect for PFS across the three arms....
To characterize exposure–response relationships of AMG 386 in a phase 2 study in advanced ovarian cancer for the facilitation
of dose selection in future studies.
.....AMG 386 (previously referred to as 2xCon4) is an investigational peptide-Fc fusion protein that mediates antiangiogenic effects
by potently and selectively inhibiting the interaction of angiopoietin-1 and angiopoietin-2 with Tie2 [16].
Primary endpoint results from a phase 2 study of AMG 386 in combination
with weekly paclitaxel for the treatment of recurrent
ovarian cancer showed longer median progression-free
survival (PFS) for patients receiving AMG 386 at 10 and 3 mg/kg once
weekly (QW), compared with placebo (the data are
described in the primary analysis [17]). Additional dose-exposure analyses suggested a dose–response effect across treatment arms......
Blogger's Note: stats removed for ease of reading (eg. CI):
Progression-free survival (the primary endpoint) in the phase 2 study was 7.2 months in the AMG 386 10 mg/kg QW dose group and 5.7 months in the 3 mg/kg group, compared with 4.6 months for placebo. Results from Tarone’s test and dose-exposure analyses suggested a dose–response effect for PFS across the three arms....
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