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])
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])