ID

21235

Description

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

Link

https://clinicaltrials.gov/show/NCT00620594

Keywords

Versions (1)
  1. 4/14/17 4/14/17 -
Uploaded on

April 14, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer, NCT00620594

English

Eligibility Breast Cancer, NCT00620594

1 forms  
Inclusion Criteria
Description

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.
Description

histologically-confirmed, advanced unresectable solid tumor

Data type

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.
Description

metastatic her2 positive breast cancer

Data type

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.
Description

histologically-confirmed, advanced unresectable solid tumors

Data type

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
Description

Exclusion Criteria

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

brain metastasis

Data type

boolean

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

pi3k inhibitor

Data type

boolean

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

liver disease, renal disease

Data type

boolean

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

ID.7

Data type

boolean

patients with unresolved diarrhea ≥ ctcae grade 2
Description

diarrhea ctcae grade

Data type

boolean

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

cardiac function, cardiac disease

Data type

boolean

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

diabetes mellitus insulin treatment

Data type

boolean

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

coagulopathy

Data type

boolean

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

photosensitivity reactions to drugs

Data type

boolean

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

ophthalmological findings

Data type

boolean

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

progressive eye disease

Data type

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
Description

loss during study period

Data type

boolean

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

ophthalmic procedures

Data type

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.
Description

comorbidities

Data type

boolean

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

inclusion/exclusion criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0680251
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Similar models

Eligibility Breast Cancer, NCT00620594

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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