ID

21235

Beschrijving

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

Trefwoorden

Versies (1)
  1. 14-04-17 14-04-17 -
Geüploaded op

14 april 2017

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Breast Cancer, NCT00620594

Engels

Eligibility Breast Cancer, NCT00620594

1 Formulieren  
Inclusion Criteria
Beschrijving

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.
Beschrijving

histologically-confirmed, advanced unresectable solid tumor

Datatype

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.
Beschrijving

metastatic her2 positive breast cancer

Datatype

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.
Beschrijving

histologically-confirmed, advanced unresectable solid tumors

Datatype

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
Beschrijving

Exclusion Criteria

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

brain metastasis

Datatype

boolean

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

pi3k inhibitor

Datatype

boolean

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

liver disease, renal disease

Datatype

boolean

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

ID.7

Datatype

boolean

patients with unresolved diarrhea ≥ ctcae grade 2
Beschrijving

diarrhea ctcae grade

Datatype

boolean

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

cardiac function, cardiac disease

Datatype

boolean

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

diabetes mellitus insulin treatment

Datatype

boolean

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

coagulopathy

Datatype

boolean

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

photosensitivity reactions to drugs

Datatype

boolean

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

ophthalmological findings

Datatype

boolean

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

progressive eye disease

Datatype

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
Beschrijving

loss during study period

Datatype

boolean

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

ophthalmic procedures

Datatype

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.
Beschrijving

comorbidities

Datatype

boolean

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

inclusion/exclusion criteria

Datatype

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0680251
Terug naar het begin van de pagina

Similar models

Eligibility Breast Cancer, NCT00620594

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial