ID

31886

Descripción

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

Palabras clave

Versiones (1)
  1. 7/10/18 7/10/18 -
Titular de derechos de autor

Genentech, Inc.

Subido en

7 de octubre de 2018

DOI

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Licencia

Creative Commons BY-NC 3.0
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Eligibility Basal Cell Carcinoma NCT01160250

Inglés

Eligibility Basal Cell Carcinoma NCT01160250

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

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

Metastatic BCC

Tipo de datos

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
Descripción

Locally advanced bcc, inoperable or surgery contraindicated

Tipo de datos

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.
Descripción

History of previous radiotherapy unless contraindicated or inappropriate

Tipo de datos

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
Descripción

Gorlin snydrome

Tipo de datos

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
Descripción

RECIST

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1709926
adequate organ function
Descripción

Adequate organ function

Tipo de datos

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)
Descripción

Women of childbearing potential willing to use contraception

Tipo de datos

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)
Descripción

Men with femal partners willing to use contraception

Tipo de datos

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
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnancy or lactation
Descripción

Pregnant or lactating

Tipo de datos

boolean

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

Life expectancy

Tipo de datos

boolean

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

Concurrent anti-tumor therapy

Tipo de datos

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
Descripción

Recent anti-tumor therapy

Tipo de datos

boolean

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

Uncontrolled comorbidity

Tipo de datos

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
Descripción

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

Tipo de datos

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
Descripción

Unwilling to use contraception

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0558080
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Similar models

Eligibility Basal Cell Carcinoma NCT01160250

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
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