AXIS: phase III study design with axitinib
•
First phase III head to head st d s a targeted agent in second line mRCC
,
‐ ‐
u y v
‐
Axitinib
R
A
N
Eligibility:
5 mg BID*
(n=361)
1 1
D
O
M
I
mRCC clear‐cell histology
Failure of one first‐line regimen
containing:
S iti ib
Sorafenib
400 mg BID
:
N=723
S
A
T
I
‒
un n
‒
Bevacizumab + IFN‐α
‒
Temsirolimus, or
‒
Cytokines
Stratification by prior regimen and
(n=362)
O
N
ECOG PS
Primary endpoint:
PFS
Rini et al. Lancet 2011