Rare Diseases Symptoms Automatic Extraction
Home
A random Abstract
Our Project
Our Team
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
"glioblastoma"
symptom
alexander disease
canavan disease
cholangiocarcinoma
erdheim-chester disease
homocystinuria without methylmalonic aciduria
kallmann syndrome
proteus syndrome
severe combined immunodeficiency
zellweger syndrome
This symptom has already been validated