ID

25923

Beskrivning

A Study Evaluating the Efficacy and Safety of Vismodegib (GDC-0449, Hedgehog Pathway Inhibitor) in Patients With Advanced Basal Cell Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00833417

Länk

https://clinicaltrials.gov/show/NCT00833417

Nyckelord

Versioner (2)
  1. 2017-09-27 2017-09-27 -
  2. 2017-09-27 2017-09-27 -
Uppladdad den

27 september 2017

DOI

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Licens

Creative Commons BY-NC 3.0
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Eligibility Basal Cell Carcinoma NCT00833417

Engelsk

Eligibility Basal Cell Carcinoma NCT00833417

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
men and women ≥ 18 years of age.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
for patients with metastatic basal cell carcinoma (bcc), histological confirmation of distant bcc metastasis (eg, lung, liver, lymph nodes, or bone), with metastatic disease that is response evaluation criteria in solid tumors (recist) measurable using computed tomography (ct) or magnetic resonance imaging (mri).
Beskrivning

Metastatic basal cell carcinoma | Basal cell carcinoma Distant metastasis | Basal cell carcinoma Distant metastasis Lung | Basal cell carcinoma Distant metastasis Liver | Basal cell carcinoma Distant metastasis Lymph nodes | Basal cell carcinoma Distant metastasis Bone | Neoplasm Metastasis Measurable CT | Neoplasm Metastasis Measurable MRI

Datatyp

boolean

Alias
UMLS CUI [1]
C1304306
UMLS CUI [2,1]
C0007117
UMLS CUI [2,2]
C1269798
UMLS CUI [3,1]
C0007117
UMLS CUI [3,2]
C1269798
UMLS CUI [3,3]
C0024109
UMLS CUI [4,1]
C0007117
UMLS CUI [4,2]
C1269798
UMLS CUI [4,3]
C0023884
UMLS CUI [5,1]
C0007117
UMLS CUI [5,2]
C1269798
UMLS CUI [5,3]
C0024204
UMLS CUI [6,1]
C0007117
UMLS CUI [6,2]
C1269798
UMLS CUI [6,3]
C0262950
UMLS CUI [7,1]
C0027627
UMLS CUI [7,2]
C1513040
UMLS CUI [7,3]
C0040405
UMLS CUI [8,1]
C0027627
UMLS CUI [8,2]
C1513040
UMLS CUI [8,3]
C0024485
for patients with locally advanced bcc, histologically confirmed disease that is considered to be inoperable.
Beskrivning

Basal cell carcinoma Advanced Locally | Disease Inoperable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007117
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C1517927
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0205187
for patients with locally advanced bcc, radiotherapy must have been previously administered for their locally advanced bcc, unless radiotherapy is contraindicated or inappropriate. for patients whose locally advanced bcc has been irradiated, disease must have progressed after radiation.
Beskrivning

Therapeutic radiology procedure Basal cell carcinoma Advanced Locally | Exception Medical contraindication Therapeutic radiology procedure | Exception Therapeutic radiology procedure Inappropriate | Disease Progression Post Therapeutic radiology procedure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0007117
UMLS CUI [1,3]
C0205179
UMLS CUI [1,4]
C1517927
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1301624
UMLS CUI [2,3]
C1522449
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1522449
UMLS CUI [3,3]
C1548788
UMLS CUI [4,1]
C0242656
UMLS CUI [4,2]
C0687676
UMLS CUI [4,3]
C1522449
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).
Beskrivning

Childbearing Potential Contraceptive methods Quantity | Contraception, Barrier | Vismodegib Discontinuation | GDC-0449 Discontinuation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C1265611
UMLS CUI [2]
C0004764
UMLS CUI [3,1]
C2987716
UMLS CUI [3,2]
C1444662
UMLS CUI [4,1]
C2348949
UMLS CUI [4,2]
C1444662
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.
Beskrivning

Gender Latex condom | Partner Female Childbearing Potential Contraceptive methods | Vismodegib Discontinuation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C3873750
UMLS CUI [2,1]
C0682323
UMLS CUI [2,2]
C0086287
UMLS CUI [2,3]
C3831118
UMLS CUI [2,4]
C0700589
UMLS CUI [3,1]
C2987716
UMLS CUI [3,2]
C1444662
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior treatment with vismodegib or other hedgehog pathway inhibitors.
Beskrivning

Vismodegib Prior Therapy | Hedgehog Pathway Inhibitor

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2987716
UMLS CUI [1,2]
C1514463
UMLS CUI [2]
C3267924
pregnancy or lactation.
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
life expectancy of < 12 weeks.
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
patients with superficial multifocal bcc who may be considered unresectable due to breadth of involvement.
Beskrivning

Multifocal superficial basal cell carcinoma unresectable Due to Involvement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0334256
UMLS CUI [1,2]
C1519810
UMLS CUI [1,3]
C0678226
UMLS CUI [1,4]
C1314939
concurrent non-protocol-specified anti-tumor therapy (eg, chemotherapy, other targeted therapy, radiation therapy, or photodynamic therapy).
Beskrivning

Cancer treatment | Chemotherapy | Targeted Therapy | Therapeutic radiology procedure | Photodynamic therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2]
C0392920
UMLS CUI [3]
C2985566
UMLS CUI [4]
C1522449
UMLS CUI [5]
C0031740
recent, current, or planned participation in an experimental drug study.
Beskrivning

Study Subject Participation Status | Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
history of other malignancies within 3 years of the first day of treatment with vismodegib in this study (day 1), except for tumors with a negligible risk for metastasis or death, such as adequately treated squamous-cell carcinoma of the skin, ductal carcinoma in situ of the breast, or carcinoma in situ of the cervix.
Beskrivning

Malignant Neoplasms | Exception Squamous cell carcinoma of skin Treated | Exception Noninfiltrating Intraductal Carcinoma Treated | Exception Carcinoma in situ of uterine cervix Treated | Vismodegib

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0553723
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007124
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
UMLS CUI [4,3]
C1522326
UMLS CUI [5]
C2987716
uncontrolled medical illnesses such as infection requiring treatment with intravenous antibiotics.
Beskrivning

Illness Uncontrolled | Communicable Disease Requirement Intravenous antibiotic therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0559680
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Similar models

Eligibility Basal Cell Carcinoma NCT00833417

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
men and women ≥ 18 years of age.
boolean
C0001779 (UMLS CUI [1])
Metastatic basal cell carcinoma | Basal cell carcinoma Distant metastasis | Basal cell carcinoma Distant metastasis Lung | Basal cell carcinoma Distant metastasis Liver | Basal cell carcinoma Distant metastasis Lymph nodes | Basal cell carcinoma Distant metastasis Bone | Neoplasm Metastasis Measurable CT | Neoplasm Metastasis Measurable MRI
Item
for patients with metastatic basal cell carcinoma (bcc), histological confirmation of distant bcc metastasis (eg, lung, liver, lymph nodes, or bone), with metastatic disease that is response evaluation criteria in solid tumors (recist) measurable using computed tomography (ct) or magnetic resonance imaging (mri).
boolean
C1304306 (UMLS CUI [1])
C0007117 (UMLS CUI [2,1])
C1269798 (UMLS CUI [2,2])
C0007117 (UMLS CUI [3,1])
C1269798 (UMLS CUI [3,2])
C0024109 (UMLS CUI [3,3])
C0007117 (UMLS CUI [4,1])
C1269798 (UMLS CUI [4,2])
C0023884 (UMLS CUI [4,3])
C0007117 (UMLS CUI [5,1])
C1269798 (UMLS CUI [5,2])
C0024204 (UMLS CUI [5,3])
C0007117 (UMLS CUI [6,1])
C1269798 (UMLS CUI [6,2])
C0262950 (UMLS CUI [6,3])
C0027627 (UMLS CUI [7,1])
C1513040 (UMLS CUI [7,2])
C0040405 (UMLS CUI [7,3])
C0027627 (UMLS CUI [8,1])
C1513040 (UMLS CUI [8,2])
C0024485 (UMLS CUI [8,3])
Basal cell carcinoma Advanced Locally | Disease Inoperable
Item
for patients with locally advanced bcc, histologically confirmed disease that is considered to be inoperable.
boolean
C0007117 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C1517927 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C0205187 (UMLS CUI [2,2])
Therapeutic radiology procedure Basal cell carcinoma Advanced Locally | Exception Medical contraindication Therapeutic radiology procedure | Exception Therapeutic radiology procedure Inappropriate | Disease Progression Post Therapeutic radiology procedure
Item
for patients with locally advanced bcc, radiotherapy must have been previously administered for their 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
C1522449 (UMLS CUI [1,1])
C0007117 (UMLS CUI [1,2])
C0205179 (UMLS CUI [1,3])
C1517927 (UMLS CUI [1,4])
C1705847 (UMLS CUI [2,1])
C1301624 (UMLS CUI [2,2])
C1522449 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1522449 (UMLS CUI [3,2])
C1548788 (UMLS CUI [3,3])
C0242656 (UMLS CUI [4,1])
C0687676 (UMLS CUI [4,2])
C1522449 (UMLS CUI [4,3])
Childbearing Potential Contraceptive methods Quantity | Contraception, Barrier | Vismodegib Discontinuation | GDC-0449 Discontinuation
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])
C1265611 (UMLS CUI [1,3])
C0004764 (UMLS CUI [2])
C2987716 (UMLS CUI [3,1])
C1444662 (UMLS CUI [3,2])
C2348949 (UMLS CUI [4,1])
C1444662 (UMLS CUI [4,2])
Gender Latex condom | Partner Female Childbearing Potential Contraceptive methods | Vismodegib Discontinuation
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.
boolean
C0079399 (UMLS CUI [1,1])
C3873750 (UMLS CUI [1,2])
C0682323 (UMLS CUI [2,1])
C0086287 (UMLS CUI [2,2])
C3831118 (UMLS CUI [2,3])
C0700589 (UMLS CUI [2,4])
C2987716 (UMLS CUI [3,1])
C1444662 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Vismodegib Prior Therapy | Hedgehog Pathway Inhibitor
Item
prior treatment with vismodegib or other hedgehog pathway inhibitors.
boolean
C2987716 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C3267924 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
pregnancy or lactation.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Life Expectancy
Item
life expectancy of < 12 weeks.
boolean
C0023671 (UMLS CUI [1])
Multifocal superficial basal cell carcinoma unresectable Due to Involvement
Item
patients with superficial multifocal bcc who may be considered unresectable due to breadth of involvement.
boolean
C0334256 (UMLS CUI [1,1])
C1519810 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C1314939 (UMLS CUI [1,4])
Cancer treatment | Chemotherapy | Targeted Therapy | Therapeutic radiology procedure | Photodynamic therapy
Item
concurrent non-protocol-specified anti-tumor therapy (eg, chemotherapy, other targeted therapy, radiation therapy, or photodynamic therapy).
boolean
C0920425 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
C2985566 (UMLS CUI [3])
C1522449 (UMLS CUI [4])
C0031740 (UMLS CUI [5])
Study Subject Participation Status | Investigational New Drugs
Item
recent, current, or planned participation in an experimental drug study.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Malignant Neoplasms | Exception Squamous cell carcinoma of skin Treated | Exception Noninfiltrating Intraductal Carcinoma Treated | Exception Carcinoma in situ of uterine cervix Treated | Vismodegib
Item
history of other malignancies within 3 years of the first day of treatment with vismodegib in this study (day 1), except for tumors with a negligible risk for metastasis or death, such as adequately treated squamous-cell carcinoma of the skin, ductal carcinoma in situ of the breast, or carcinoma in situ of the cervix.
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0553723 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0007124 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C2987716 (UMLS CUI [5])
Illness Uncontrolled | Communicable Disease Requirement Intravenous antibiotic therapy
Item
uncontrolled medical illnesses such as infection requiring treatment with intravenous antibiotics.
boolean
C0221423 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0559680 (UMLS CUI [2,3])
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