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])
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])