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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
"pain"
symptom
achondroplasia
acute rheumatic fever
adrenal incidentaloma
adrenomyeloneuropathy
aniridia
aromatase deficiency
carcinoma of the gallbladder
cholangiocarcinoma
coats disease
congenital diaphragmatic hernia
congenital toxoplasmosis
cushing syndrome
cutaneous mastocytosis
cystinuria
dedifferentiated liposarcoma
dentin dysplasia
dracunculiasis
dystrophic epidermolysis bullosa
epidermolysis bullosa simplex
erdheim-chester disease
erythropoietic protoporphyria
esophageal adenocarcinoma
esophageal carcinoma
esophageal squamous cell carcinoma
fabry disease
familial mediterranean fever
focal myositis
hirschsprung disease
hodgkin lymphoma, classical
holt-oram syndrome
junctional epidermolysis bullosa
kabuki syndrome
kindler syndrome
lamellar ichthyosis
liposarcoma
locked-in syndrome
lymphangioleiomyomatosis
malignant atrophic papulosis
neuralgic amyotrophy
oligodontia
oral submucous fibrosis
papillon-lefèvre syndrome
phenylketonuria
pleomorphic liposarcoma
primary hyperoxaluria type 1
proteus syndrome
pyomyositis
scrub typhus
sneddon syndrome
systemic capillary leak syndrome
thoracic outlet syndrome
trochlear dysplasia
typhoid
von hippel-lindau disease
waldenström macroglobulinemia
well-differentiated liposarcoma
wolf-hirschhorn syndrome
This symptom has already been validated