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])