ID

31886

Description

A Study of Vismodegib (GDC-0449) in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01160250

Link

https://clinicaltrials.gov/show/NCT01160250

Keywords

Versions (1)
  1. 10/7/18 10/7/18 -
Copyright Holder

Genentech, Inc.

Uploaded on

October 7, 2018

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Basal Cell Carcinoma NCT01160250

English

Eligibility Basal Cell Carcinoma NCT01160250

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
for patients with mbcc, histologic confirmation of distant bcc metastasis
Description

Metastatic BCC

Data type

boolean

Alias
UMLS CUI [1,1]
C0007117
UMLS CUI [1,2]
C0027627
UMLS CUI [1,3]
C0005558
for patients with locally advanced bcc, at least one histologically confirmed lesion 10 mm or more in diameter and written confirmation from a surgical specialist that the tumor is considered inoperable or that surgery is contraindicated
Description

Locally advanced bcc, inoperable or surgery contraindicated

Data type

boolean

Alias
UMLS CUI [1,1]
C0007117
UMLS CUI [1,2]
C0677984
UMLS CUI [1,3]
C0005558
UMLS CUI [1,4]
C0205187
UMLS CUI [2]
C0449453
UMLS CUI [3,1]
C0543467
UMLS CUI [3,2]
C0522473
for patients with locally advanced bcc, radiotherapy must have been previously administered for locally advanced bcc, unless radiotherapy is contraindicated or inappropriate. for patients whose locally advanced bcc has been irradiated, disease must have progressed after radiation.
Description

History of previous radiotherapy unless contraindicated or inappropriate

Data type

boolean

Alias
UMLS CUI [1,1]
C0677984
UMLS CUI [1,2]
C0007117
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0677984
UMLS CUI [2,3]
C0007117
UMLS CUI [3,1]
C0332300
UMLS CUI [3,2]
C1301624
UMLS CUI [4,1]
C0332300
UMLS CUI [4,2]
C1548788
UMLS CUI [5,1]
C0242656
UMLS CUI [5,2]
C0687676
UMLS CUI [5,3]
C1522449
patients with gorlin syndrome may enroll in this study but must meet the criteria for locally advanced or metastatic disease listed above
Description

Gorlin snydrome

Data type

boolean

Alias
UMLS CUI [1,1]
C0004779
UMLS CUI [1,2]
C1879533
patients with measurable and/or non-measurable disease (as defined by recist) are allowed
Description

RECIST

Data type

boolean

Alias
UMLS CUI [1]
C1709926
adequate organ function
Description

Adequate organ function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
for women of childbearing potential, agreement to the use of two acceptable methods of contraception, including one barrier method, during the study and for 12 months after discontinuation of vismodegib (gdc-0449)
Description

Women of childbearing potential willing to use contraception

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0600109
for men with female partners of childbearing potential, agreement to use a latex condom, and to advise their female partner to use an additional method of contraception during the study and for 3 months after discontinuation of vismodegib (gdc-0449)
Description

Men with femal partners willing to use contraception

Data type

boolean

Alias
UMLS CUI [1,1]
C1706180
UMLS CUI [1,2]
C0682323
UMLS CUI [1,3]
C3831118
UMLS CUI [1,4]
C0700589
UMLS CUI [1,5]
C0600109
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnancy or lactation
Description

Pregnant or lactating

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
life expectancy < 12 weeks
Description

Life expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
concurrent non-protocol-specified anti-tumor therapy
Description

Concurrent anti-tumor therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205420
UMLS CUI [1,3]
C1518384
completion of most recent anti-tumor therapy at least 21 days prior to initiation of treatment
Description

Recent anti-tumor therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0332185
uncontrolled medical illnesses such as infection requiring treatment with intravenous antibiotics
Description

Uncontrolled comorbidity

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0338237
UMLS CUI [2,3]
C0348016
history of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or renders the patient at high risk from treatment complications
Description

Comorbidity affecting study, metabolic dysfunction, physical examination finding, clinical labaratory

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C2348563
UMLS CUI [2,1]
C0031809
UMLS CUI [2,2]
C1301624
UMLS CUI [3,1]
C0025517
UMLS CUI [3,2]
C1301624
UMLS CUI [4,1]
C0587081
UMLS CUI [4,2]
C1301624
unwillingness to practice effective birth control
Description

Unwilling to use contraception

Data type

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0558080
Back to the top of the page

Similar models

Eligibility Basal Cell Carcinoma NCT01160250

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Metastatic BCC
Item
for patients with mbcc, histologic confirmation of distant bcc metastasis
boolean
C0007117 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
C0005558 (UMLS CUI [1,3])
Locally advanced bcc, inoperable or surgery contraindicated
Item
for patients with locally advanced bcc, at least one histologically confirmed lesion 10 mm or more in diameter and written confirmation from a surgical specialist that the tumor is considered inoperable or that surgery is contraindicated
boolean
C0007117 (UMLS CUI [1,1])
C0677984 (UMLS CUI [1,2])
C0005558 (UMLS CUI [1,3])
C0205187 (UMLS CUI [1,4])
C0449453 (UMLS CUI [2])
C0543467 (UMLS CUI [3,1])
C0522473 (UMLS CUI [3,2])
History of previous radiotherapy unless contraindicated or inappropriate
Item
for patients with locally advanced bcc, radiotherapy must have been previously administered for locally advanced bcc, unless radiotherapy is contraindicated or inappropriate. for patients whose locally advanced bcc has been irradiated, disease must have progressed after radiation.
boolean
C0677984 (UMLS CUI [1,1])
C0007117 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0677984 (UMLS CUI [2,2])
C0007117 (UMLS CUI [2,3])
C0332300 (UMLS CUI [3,1])
C1301624 (UMLS CUI [3,2])
C0332300 (UMLS CUI [4,1])
C1548788 (UMLS CUI [4,2])
C0242656 (UMLS CUI [5,1])
C0687676 (UMLS CUI [5,2])
C1522449 (UMLS CUI [5,3])
Gorlin snydrome
Item
patients with gorlin syndrome may enroll in this study but must meet the criteria for locally advanced or metastatic disease listed above
boolean
C0004779 (UMLS CUI [1,1])
C1879533 (UMLS CUI [1,2])
RECIST
Item
patients with measurable and/or non-measurable disease (as defined by recist) are allowed
boolean
C1709926 (UMLS CUI [1])
Adequate organ function
Item
adequate organ function
boolean
C0678852 (UMLS CUI [1])
Women of childbearing potential willing to use contraception
Item
for women of childbearing potential, agreement to the use of two acceptable methods of contraception, including one barrier method, during the study and for 12 months after discontinuation of vismodegib (gdc-0449)
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
Men with femal partners willing to use contraception
Item
for men with female partners of childbearing potential, agreement to use a latex condom, and to advise their female partner to use an additional method of contraception during the study and for 3 months after discontinuation of vismodegib (gdc-0449)
boolean
C1706180 (UMLS CUI [1,1])
C0682323 (UMLS CUI [1,2])
C3831118 (UMLS CUI [1,3])
C0700589 (UMLS CUI [1,4])
C0600109 (UMLS CUI [1,5])
Item Group
C0680251 (UMLS CUI)
Pregnant or lactating
Item
pregnancy or lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Life expectancy
Item
life expectancy < 12 weeks
boolean
C0023671 (UMLS CUI [1])
Concurrent anti-tumor therapy
Item
concurrent non-protocol-specified anti-tumor therapy
boolean
C0920425 (UMLS CUI [1,1])
C0205420 (UMLS CUI [1,2])
C1518384 (UMLS CUI [1,3])
Recent anti-tumor therapy
Item
completion of most recent anti-tumor therapy at least 21 days prior to initiation of treatment
boolean
C0920425 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Uncontrolled comorbidity
Item
uncontrolled medical illnesses such as infection requiring treatment with intravenous antibiotics
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C0338237 (UMLS CUI [2,2])
C0348016 (UMLS CUI [2,3])
Comorbidity affecting study, metabolic dysfunction, physical examination finding, clinical labaratory
Item
history of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or renders the patient at high risk from treatment complications
boolean
C0009488 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
C0031809 (UMLS CUI [2,1])
C1301624 (UMLS CUI [2,2])
C0025517 (UMLS CUI [3,1])
C1301624 (UMLS CUI [3,2])
C0587081 (UMLS CUI [4,1])
C1301624 (UMLS CUI [4,2])
Unwilling to use contraception
Item
unwillingness to practice effective birth control
boolean
C0700589 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

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