ID

36280

Description

A Phase 2 Study of B-701 in Treatment of Locally Advanced or Metastatic Urothelial Cell Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT02401542

Link

https://clinicaltrials.gov/show/NCT02401542

Keywords

Versions (1)
  1. 4/29/19 4/29/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 29, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Locally Advanced or Metastatic Urothelial Cell Carcinoma NCT02401542

English

Eligibility Locally Advanced or Metastatic Urothelial Cell Carcinoma NCT02401542

1 forms  
Criteria
Description

Criteria

provide tumor tissue obtained within 18 months of enrollment of suitable quality and quantity and to demonstrate fgfr3 positive tumor by ihc. for subjects participating in the randomized phase only, if suitable archival tissue is unavailable, then a core biopsy of tumor tissue (metastatic or primary) must be obtained prior to randomization
Description

Tumor tissue sample | Tumor FGF3 Positive Immunohistochemistry | Tumor tissue metastatic Core biopsy | Tumor tissue Primary Core biopsy

Data type

boolean

Alias
UMLS CUI [1]
C0475358
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C0812290
UMLS CUI [2,3]
C1514241
UMLS CUI [2,4]
C0021044
UMLS CUI [3,1]
C0475358
UMLS CUI [3,2]
C1522484
UMLS CUI [3,3]
C1318309
UMLS CUI [4,1]
C0475358
UMLS CUI [4,2]
C0205225
UMLS CUI [4,3]
C1318309
stage iv, locally advanced or metastatic urothelial bladder cancer or transitional cell carcinoma arising in another location of the urinary tract, including urethra, ureter, and renal pelvis
Description

Urothelial carcinoma bladder Advanced Locally TNM clinical staging | Urothelial carcinoma bladder metastatic TNM clinical staging | Transitional cell carcinoma of the urinary tract | Transitional cell carcinoma urethra | Transitional cell carcinoma of ureter | Transitional cell carcinoma of renal pelvis

Data type

boolean

Alias
UMLS CUI [1,1]
C0279680
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C1517927
UMLS CUI [1,4]
C3258246
UMLS CUI [2,1]
C0279680
UMLS CUI [2,2]
C1522484
UMLS CUI [2,3]
C3258246
UMLS CUI [3]
C2145472
UMLS CUI [4]
C0863015
UMLS CUI [5]
C0577692
UMLS CUI [6]
C4087468
relapsed after or are refractory to one or two prior lines of chemotherapy which have not included a taxane platinum agent, as long as a platinum agent is not contraindicated for the subject (i.e., if a platinum agent is contraindicated for a subject, the one or two prior regimen need not have included a platinum agent)
Description

Status post Prior Chemotherapy Course Quantity | Recurrent disease | Refractory Disease | Taxane Absent | Platinum-based chemotherapy Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0231290
UMLS CUI [1,2]
C1514457
UMLS CUI [1,3]
C0750729
UMLS CUI [1,4]
C1265611
UMLS CUI [2]
C0277556
UMLS CUI [3]
C1514815
UMLS CUI [4,1]
C0215136
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C3536920
UMLS CUI [5,2]
C0332197
measurable disease according to recist v1.1 criteria
Description

Measurable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
≥ 18 years old
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
ecog 0 or 1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
main exclusion criteria:
Description

Exclusion Criteria Main

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
prior anti-cancer therapy within 4 weeks prior to cycle 1, day 1
Description

Cancer treatment

Data type

boolean

Alias
UMLS CUI [1]
C0920425
weight > 100kg
Description

Body Weight

Data type

boolean

Alias
UMLS CUI [1]
C0005910
clinically significant comorbid medical conditions or lab abnormalities
Description

Comorbidity Clinical Significance | Laboratory test result abnormal

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C2826293
UMLS CUI [2]
C0438215
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Similar models

Eligibility Locally Advanced or Metastatic Urothelial Cell Carcinoma NCT02401542

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Tumor tissue sample | Tumor FGF3 Positive Immunohistochemistry | Tumor tissue metastatic Core biopsy | Tumor tissue Primary Core biopsy
Item
provide tumor tissue obtained within 18 months of enrollment of suitable quality and quantity and to demonstrate fgfr3 positive tumor by ihc. for subjects participating in the randomized phase only, if suitable archival tissue is unavailable, then a core biopsy of tumor tissue (metastatic or primary) must be obtained prior to randomization
boolean
C0475358 (UMLS CUI [1])
C0027651 (UMLS CUI [2,1])
C0812290 (UMLS CUI [2,2])
C1514241 (UMLS CUI [2,3])
C0021044 (UMLS CUI [2,4])
C0475358 (UMLS CUI [3,1])
C1522484 (UMLS CUI [3,2])
C1318309 (UMLS CUI [3,3])
C0475358 (UMLS CUI [4,1])
C0205225 (UMLS CUI [4,2])
C1318309 (UMLS CUI [4,3])
Urothelial carcinoma bladder Advanced Locally TNM clinical staging | Urothelial carcinoma bladder metastatic TNM clinical staging | Transitional cell carcinoma of the urinary tract | Transitional cell carcinoma urethra | Transitional cell carcinoma of ureter | Transitional cell carcinoma of renal pelvis
Item
stage iv, locally advanced or metastatic urothelial bladder cancer or transitional cell carcinoma arising in another location of the urinary tract, including urethra, ureter, and renal pelvis
boolean
C0279680 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C1517927 (UMLS CUI [1,3])
C3258246 (UMLS CUI [1,4])
C0279680 (UMLS CUI [2,1])
C1522484 (UMLS CUI [2,2])
C3258246 (UMLS CUI [2,3])
C2145472 (UMLS CUI [3])
C0863015 (UMLS CUI [4])
C0577692 (UMLS CUI [5])
C4087468 (UMLS CUI [6])
Status post Prior Chemotherapy Course Quantity | Recurrent disease | Refractory Disease | Taxane Absent | Platinum-based chemotherapy Absent
Item
relapsed after or are refractory to one or two prior lines of chemotherapy which have not included a taxane platinum agent, as long as a platinum agent is not contraindicated for the subject (i.e., if a platinum agent is contraindicated for a subject, the one or two prior regimen need not have included a platinum agent)
boolean
C0231290 (UMLS CUI [1,1])
C1514457 (UMLS CUI [1,2])
C0750729 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
C0277556 (UMLS CUI [2])
C1514815 (UMLS CUI [3])
C0215136 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C3536920 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
Measurable Disease
Item
measurable disease according to recist v1.1 criteria
boolean
C1513041 (UMLS CUI [1])
Age
Item
≥ 18 years old
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog 0 or 1
boolean
C1520224 (UMLS CUI [1])
Exclusion Criteria Main
Item
main exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Cancer treatment
Item
prior anti-cancer therapy within 4 weeks prior to cycle 1, day 1
boolean
C0920425 (UMLS CUI [1])
Body Weight
Item
weight > 100kg
boolean
C0005910 (UMLS CUI [1])
Comorbidity Clinical Significance | Laboratory test result abnormal
Item
clinically significant comorbid medical conditions or lab abnormalities
boolean
C0009488 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0438215 (UMLS CUI [2])
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