ID

21235

Beskrivning

A Phase I/II Study of BEZ235 in Patients With Advanced Solid Malignancies Enriched by Patients With Advanced Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00620594

Länk

https://clinicaltrials.gov/show/NCT00620594

Nyckelord

Versioner (1)
  1. 2017-04-14 2017-04-14 -
Uppladdad den

14 april 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer, NCT00620594

Engelsk

Eligibility Breast Cancer, NCT00620594

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
[single agent dose escalation arm]: patients with histologically-confirmed, advanced unresectable solid tumors including cs patients who have progressed on (or not been able to tolerate) standard therapy within three months before screening visit or for whom no standard anticancer therapy exists.
Beskrivning

histologically-confirmed, advanced unresectable solid tumor

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1336869
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C0019638
UMLS CUI [1,4]
C2936643
[combination part]: patients with metastatic her2+ breast cancer, after failure of trastuzumab treatment. eligible patients will have to have tumors carrying molecular alterations of pik3ca and/or pten.
Beskrivning

metastatic her2 positive breast cancer

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0006142
UMLS CUI [1,2]
C0242957
UMLS CUI [1,3]
C0027627
UMLS CUI [1,4]
C1335212
UMLS CUI [1,5]
C0694888
UMLS CUI [1,6]
C0728747
[single agent safety expansion arm]: patients with histologically-confirmed, advanced unresectable solid tumors including cs patients who have progressed on (or not been able to tolerate) standard therapy within three months before screening visit or for whom no standard anticancer therapy exists. patients will be prescreened for molecular alterations affecting pik3ca and/or pten. patients with nsclc will also be pre-screened for egfr mutation.
Beskrivning

histologically-confirmed, advanced unresectable solid tumors

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1336869
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C0019638
UMLS CUI [1,4]
C2936643
UMLS CUI [1,5]
C0220908
UMLS CUI [1,6]
C1335212
UMLS CUI [1,7]
C0694888
UMLS CUI [2,1]
C0007131
UMLS CUI [2,2]
C0220908
UMLS CUI [2,3]
C0034802
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who have brain metastases, which are progressive and/or requiring medical intervention for symptom control
Beskrivning

brain metastasis

Datatyp

boolean

Alias
UMLS CUI [1]
C0220650
prior treatment with a pi3k inhibitor
Beskrivning

pi3k inhibitor

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0044602
UMLS CUI [1,2]
C1999216
acute or chronic liver disease or renal disease
Beskrivning

liver disease, renal disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0022658
acute or chronic pancreatitis
Beskrivning

ID.7

Datatyp

boolean

patients with unresolved diarrhea ≥ ctcae grade 2
Beskrivning

diarrhea ctcae grade

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0011991
UMLS CUI [1,2]
C1516728
impaired cardiac function or clinically significant cardiac diseases
Beskrivning

cardiac function, cardiac disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0232164
UMLS CUI [2]
C0018799
patients with diabetes mellitus requiring insulin treatment
Beskrivning

diabetes mellitus insulin treatment

Datatyp

boolean

Alias
UMLS CUI [1]
C0011854
patients with known coagulopathies
Beskrivning

coagulopathy

Datatyp

boolean

Alias
UMLS CUI [1]
C0005779
patients with a history of photosensitivity reactions to other drugs
Beskrivning

photosensitivity reactions to drugs

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0041755
UMLS CUI [1,2]
C0349506
any of the following ophthalmological findings:
Beskrivning

ophthalmological findings

Datatyp

boolean

Alias
UMLS CUI [1]
C0429488
progressive eye disease that could lead to severe loss of visual acuity or visual field
Beskrivning

progressive eye disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0015397
UMLS CUI [1,2]
C0205329
UMLS CUI [1,3]
C0042812
UMLS CUI [1,4]
C0042826
loss during the study period
Beskrivning

loss during study period

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1517945
UMLS CUI [1,2]
C0008972
inability to perform the ophthalmic procedures required in this protocol
Beskrivning

ophthalmic procedures

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0200146
UMLS CUI [1,2]
C0085732
other concurrent severe and/or uncontrolled concomitant medical conditions (e.g. active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol.
Beskrivning

comorbidities

Datatyp

boolean

Alias
UMLS CUI [1]
C0009488
other protocol-defined inclusion/exclusion criteria may apply
Beskrivning

inclusion/exclusion criteria

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0680251
Tillbaka till toppen

Similar models

Eligibility Breast Cancer, NCT00620594

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
histologically-confirmed, advanced unresectable solid tumor
Item
[single agent dose escalation arm]: patients with histologically-confirmed, advanced unresectable solid tumors including cs patients who have progressed on (or not been able to tolerate) standard therapy within three months before screening visit or for whom no standard anticancer therapy exists.
boolean
C1336869 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0019638 (UMLS CUI [1,3])
C2936643 (UMLS CUI [1,4])
metastatic her2 positive breast cancer
Item
[combination part]: patients with metastatic her2+ breast cancer, after failure of trastuzumab treatment. eligible patients will have to have tumors carrying molecular alterations of pik3ca and/or pten.
boolean
C0006142 (UMLS CUI [1,1])
C0242957 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
C1335212 (UMLS CUI [1,4])
C0694888 (UMLS CUI [1,5])
C0728747 (UMLS CUI [1,6])
histologically-confirmed, advanced unresectable solid tumors
Item
[single agent safety expansion arm]: patients with histologically-confirmed, advanced unresectable solid tumors including cs patients who have progressed on (or not been able to tolerate) standard therapy within three months before screening visit or for whom no standard anticancer therapy exists. patients will be prescreened for molecular alterations affecting pik3ca and/or pten. patients with nsclc will also be pre-screened for egfr mutation.
boolean
C1336869 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0019638 (UMLS CUI [1,3])
C2936643 (UMLS CUI [1,4])
C0220908 (UMLS CUI [1,5])
C1335212 (UMLS CUI [1,6])
C0694888 (UMLS CUI [1,7])
C0007131 (UMLS CUI [2,1])
C0220908 (UMLS CUI [2,2])
C0034802 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
brain metastasis
Item
patients who have brain metastases, which are progressive and/or requiring medical intervention for symptom control
boolean
C0220650 (UMLS CUI [1])
pi3k inhibitor
Item
prior treatment with a pi3k inhibitor
boolean
C0044602 (UMLS CUI [1,1])
C1999216 (UMLS CUI [1,2])
liver disease, renal disease
Item
acute or chronic liver disease or renal disease
boolean
C0023895 (UMLS CUI [1])
C0022658 (UMLS CUI [2])
ID.7
Item
acute or chronic pancreatitis
boolean
diarrhea ctcae grade
Item
patients with unresolved diarrhea ≥ ctcae grade 2
boolean
C0011991 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
cardiac function, cardiac disease
Item
impaired cardiac function or clinically significant cardiac diseases
boolean
C0232164 (UMLS CUI [1])
C0018799 (UMLS CUI [2])
diabetes mellitus insulin treatment
Item
patients with diabetes mellitus requiring insulin treatment
boolean
C0011854 (UMLS CUI [1])
coagulopathy
Item
patients with known coagulopathies
boolean
C0005779 (UMLS CUI [1])
photosensitivity reactions to drugs
Item
patients with a history of photosensitivity reactions to other drugs
boolean
C0041755 (UMLS CUI [1,1])
C0349506 (UMLS CUI [1,2])
ophthalmological findings
Item
any of the following ophthalmological findings:
boolean
C0429488 (UMLS CUI [1])
progressive eye disease
Item
progressive eye disease that could lead to severe loss of visual acuity or visual field
boolean
C0015397 (UMLS CUI [1,1])
C0205329 (UMLS CUI [1,2])
C0042812 (UMLS CUI [1,3])
C0042826 (UMLS CUI [1,4])
loss during study period
Item
loss during the study period
boolean
C1517945 (UMLS CUI [1,1])
C0008972 (UMLS CUI [1,2])
ophthalmic procedures
Item
inability to perform the ophthalmic procedures required in this protocol
boolean
C0200146 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
comorbidities
Item
other concurrent severe and/or uncontrolled concomitant medical conditions (e.g. active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol.
boolean
C0009488 (UMLS CUI [1])
inclusion/exclusion criteria
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C1512693 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
Tillbaka till toppen 

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