ID

31750

Description

A Study of Two Vismodegib Regimens in Patients With Multiple Basal Cell Carcinomas; ODM derived from: https://clinicaltrials.gov/show/NCT01815840 Sponsor: Hoffmann-La Roche Information provided by (Responsible Party): Hoffmann-La Roche Study Director: Clinical Trials Hoffmann-La Roche

Link

https://clinicaltrials.gov/show/NCT01815840

Keywords

Versions (2)
  1. 9/23/18 9/23/18 -
  2. 9/25/18 9/25/18 -
Copyright Holder

Hoffmann-La Roche

Uploaded on

September 25, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Basal Cell Carcinoma NCT01815840

English

Eligibility Basal Cell Carcinoma NCT01815840

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult patients, >/= 18 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients with multiple basal cell carcinomas, including patients with gorlin syndrome, with at least 6 clinically evident basal cell carcinomas at the time of randomization, of which 3 measure 5 mm or more in diameter and are considered target lesions. all other lesions are considered to be non-target lesions
Description

Multiple basal cell carcinomas as for example in gorlin syndromes, at least 6 basal cell carcinomas of which 3 measure at least 5mm in diameter and are considered target lesions

Data type

boolean

Alias
UMLS CUI [1,1]
C1854245
UMLS CUI [1,2]
C0449788
UMLS CUI [2,1]
C1854245
UMLS CUI [2,2]
C0475440
UMLS CUI [3]
C0004779
UMLS CUI [4]
C2986546
histopathologic confirmation that at least one of the three target lesions is basal cell carcinoma
Description

histopathologic confirmation that at least one of the three target lesions is basal cell carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0007117
UMLS CUI [1,2]
C0449575
eastern cooperative oncology group (ecog) performance status of 0, 1 or 2
Description

ecog status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
adequate renal and hepatic function and hematopoietic capacity
Description

adequate renal and hepatic function and hematopoietic capacity

Data type

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0018951
women of childbearing potential must agree to use contraception as defined by protocol during treatment and for at least 7 months after completion of study treatment
Description

Women of childbearing potential agreeing to use contraception as defined by protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C0043210
UMLS CUI [1,2]
C3831118
UMLS CUI [1,3]
C0700589
male patients with female partners of childbearing potential must agree to use contraception as defined by protocol during treatment and for 2 months after completion of study treatment
Description

male patients with female partners of childbearing potential agreeing to use contraception as defined by protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C0086582
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0682323
UMLS CUI [1,4]
C3831118
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
inability or unwillingness to swallow capsules
Description

inability or unwillingness to swallow capsules

Data type

boolean

Alias
UMLS CUI [1,1]
C0566355
UMLS CUI [1,2]
C0006935
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0558080
UMLS CUI [2,2]
C4521686
UMLS CUI [2,3]
C0006935
pregnant or breastfeeding women
Description

pregnancy or breastfeeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
any metastatic basal cell carcinoma
Description

metastatic basal cell carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0007117
UMLS CUI [1,2]
C0036525
locally advanced basal cell carcinoma lesion that is considered to be inoperable or to have medical contraindications to surgery
Description

inoperable basal cell carcinoma lesion

Data type

boolean

Alias
UMLS CUI [1,1]
C0205187
UMLS CUI [1,2]
C0007117
recent (.i.e. within the past 28 days prior to randomization) or current participation in another experimental drug study
Description

recent or current participation in another experimental drug study

Data type

boolean

Alias
UMLS CUI [1,1]
C0521116
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0013230
UMLS CUI [2,1]
C0332185
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C0013230
known or suspected alcohol abuse
Description

known or suspected alcohol abuse

Data type

boolean

Alias
UMLS CUI [1,1]
C0085762
UMLS CUI [1,2]
C0750491
UMLS CUI [2]
C0085762
one of the following known rare hereditary conditions: galactose intolerance, primary hypolactasia or glucose-galactose malabsorption
Description

galactose intolerance, primary hypolactasia or glucose-galactose malabsorption

Data type

boolean

Alias
UMLS CUI [1]
C0268186
UMLS CUI [2]
C0016952
UMLS CUI [3]
C0022951
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Similar models

Eligibility Basal Cell Carcinoma NCT01815840

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
adult patients, >/= 18 years of age
boolean
C0001779 (UMLS CUI [1])
Multiple basal cell carcinomas as for example in gorlin syndromes, at least 6 basal cell carcinomas of which 3 measure at least 5mm in diameter and are considered target lesions
Item
patients with multiple basal cell carcinomas, including patients with gorlin syndrome, with at least 6 clinically evident basal cell carcinomas at the time of randomization, of which 3 measure 5 mm or more in diameter and are considered target lesions. all other lesions are considered to be non-target lesions
boolean
C1854245 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C1854245 (UMLS CUI [2,1])
C0475440 (UMLS CUI [2,2])
C0004779 (UMLS CUI [3])
C2986546 (UMLS CUI [4])
histopathologic confirmation that at least one of the three target lesions is basal cell carcinoma
Item
histopathologic confirmation that at least one of the three target lesions is basal cell carcinoma
boolean
C0007117 (UMLS CUI [1,1])
C0449575 (UMLS CUI [1,2])
ecog status
Item
eastern cooperative oncology group (ecog) performance status of 0, 1 or 2
boolean
C1520224 (UMLS CUI [1])
adequate renal and hepatic function and hematopoietic capacity
Item
adequate renal and hepatic function and hematopoietic capacity
boolean
C0232804 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0018951 (UMLS CUI [3])
Women of childbearing potential agreeing to use contraception as defined by protocol
Item
women of childbearing potential must agree to use contraception as defined by protocol during treatment and for at least 7 months after completion of study treatment
boolean
C0043210 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
male patients with female partners of childbearing potential agreeing to use contraception as defined by protocol
Item
male patients with female partners of childbearing potential must agree to use contraception as defined by protocol during treatment and for 2 months after completion of study treatment
boolean
C0086582 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0682323 (UMLS CUI [1,3])
C3831118 (UMLS CUI [1,4])
Item Group
C0680251 (UMLS CUI)
inability or unwillingness to swallow capsules
Item
inability or unwillingness to swallow capsules
boolean
C0566355 (UMLS CUI [1,1])
C0006935 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0558080 (UMLS CUI [2,1])
C4521686 (UMLS CUI [2,2])
C0006935 (UMLS CUI [2,3])
pregnancy or breastfeeding
Item
pregnant or breastfeeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
metastatic basal cell carcinoma
Item
any metastatic basal cell carcinoma
boolean
C0007117 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
inoperable basal cell carcinoma lesion
Item
locally advanced basal cell carcinoma lesion that is considered to be inoperable or to have medical contraindications to surgery
boolean
C0205187 (UMLS CUI [1,1])
C0007117 (UMLS CUI [1,2])
recent or current participation in another experimental drug study
Item
recent (.i.e. within the past 28 days prior to randomization) or current participation in another experimental drug study
boolean
C0521116 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
C0332185 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
known or suspected alcohol abuse
Item
known or suspected alcohol abuse
boolean
C0085762 (UMLS CUI [1,1])
C0750491 (UMLS CUI [1,2])
C0085762 (UMLS CUI [2])
galactose intolerance, primary hypolactasia or glucose-galactose malabsorption
Item
one of the following known rare hereditary conditions: galactose intolerance, primary hypolactasia or glucose-galactose malabsorption
boolean
C0268186 (UMLS CUI [1])
C0016952 (UMLS CUI [2])
C0022951 (UMLS CUI [3])
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