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Bosutinib plus capecitabine for selected advanced solid tumours: results of a phase 1 dose-escalation study.
[cholangiocarcinoma]
Background
:
This
phase
1
study
evaluated
the
maximum
tolerated
dose
(
MTD
)
,
safety
,
and
efficacy
of
bosutinib
(
competitive
Src
/
Abl
tyrosine
kinase
inhibitor
)
plus
capecitabine
.
Methods
:
Patients
with
locally
advanced
/
metastatic
breast
,
pancreatic
,
or
colorectal
cancers
;
cholangiocarcinoma
;
or
glioblastoma
received
bosutinib
plus
capecitabine
at
eight
of
nine
possible
dose
combinations
using
an
'
up-down
'
design
to
determine
the
toxicity
contour
of
the
combination
.
Results
:
Among
32
enrolled
patients
,
none
of
the
9
patients
receiving
MTD
(
bosutinib
300
mg
once
daily
plus
capecitabine
1000
mg
m
(
-
2
)
twice
daily
)
experienced
dose-limiting
toxicities
(
DLTs
)
.
Overall
,
2
out
of
31
(
6
%
)
evaluable
patients
experienced
DLTs
(
grade
3
neurologic
pain
(
n
=
1
)
;
grade
3
pruritus
/
rash
and
increased
alanine
aminotransferase
(
n
=
1
)
)
.
Most
common
treatment-related
adverse
events
(
AEs
)
were
diarrhoea
,
nausea
,
vomiting
,
palmar
-
plantar
erythrodysesthesia
(
PPE
)
,
fatigue
;
most
frequent
grade
3
/
4
AEs
:
PPE
,
fatigue
,
and
increased
alanine
/
aspartate
aminotransferase
.
Although
diarrhoea
was
common
,
91
%
of
affected
patients
experienced
maximum
grade
1
/
2
events
that
resolved
.
Best
overall
confirmed
partial
response
or
stable
disease
>
24
weeks
(
all
tumour
types
)
was
observed
in
6
and
13
%
of
patients
.
Conclusions
:
In
this
population
of
patients
with
advanced
solid
tumours
,
bosutinib
plus
capecitabine
demonstrated
a
safety
profile
similar
to
that
previously
reported
for
bosutinib
or
capecitabine
monotherapy
;
limited
efficacy
was
observed
.
British
Journal
of
Cancer
advance
online
publication
,
7
October
2014
.
doi
:
10
.
1038
/
bjc
.
2014
.
508
www
.
bjcancer
.
com
.
Diseases
Validation
Diseases presenting
"fatigue"
symptom
benign recurrent intrahepatic cholestasis
cholangiocarcinoma
congenital adrenal hyperplasia
cowden syndrome
cutaneous mastocytosis
dedifferentiated liposarcoma
dracunculiasis
erdheim-chester disease
esophageal carcinoma
fabry disease
familial hypocalciuric hypercalcemia
familial mediterranean fever
hydrocephalus with stenosis of the aqueduct of sylvius
inclusion body myositis
kabuki syndrome
lymphangioleiomyomatosis
neuralgic amyotrophy
pleomorphic liposarcoma
systemic capillary leak syndrome
triple a syndrome
typhoid
von hippel-lindau disease
waldenström macroglobulinemia
x-linked adrenoleukodystrophy
This symptom has already been validated