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ID
22928
Descrição
Study of XL999 in Patients With Metastatic Renal Cell Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00277316
Link
https://clinicaltrials.gov/show/NCT00277316
Palavras-chave
Versões (1)
- 16/06/2017 16/06/2017 -
Transferido a
16 de junho de 2017
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Renal Cell Carcinoma NCT00277316
Eligibility Renal Cell Carcinoma NCT00277316
- StudyEvent: Eligibility
Similar models
Eligibility Renal Cell Carcinoma NCT00277316
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Clear-cell metastatic renal cell carcinoma
Item
males and females with histologically confirmed metastatic clear cell rcc
boolean
C2931852 (UMLS CUI [1])
Measurable Disease
Item
measurable disease according to response criteria for solid tumors (recist)
boolean
C1513041 (UMLS CUI [1])
Cytotoxic Chemotherapy Systemic
Item
no prior systemic cytotoxic chemotherapy
boolean
C0677881 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0205373 (UMLS CUI [1,2])
Renal Cell Carcinoma untreated | Immunotherapy Systemic | Interleukin-2 therapy | Interferon therapy | Pharmaceutical Preparation Targeting Vascular Endothelial Growth Factors | Pharmaceutical Preparation Targeting Vascular Endothelial Growth Factor Receptor | bevacizumab | sorafenib | sunitinib malate
Item
subjects who have received either no prior therapy for rcc, systemic immunotherapy only (such as interleukin-2 or interferon), or one agent targeting vegf or a vegfr (eg, bevacizumab, sorafenib, or sunitinib malate) may be enrolled
boolean
C0007134 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0021083 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C0199975 (UMLS CUI [3])
C0279030 (UMLS CUI [4])
C0013227 (UMLS CUI [5,1])
C1521840 (UMLS CUI [5,2])
C1256770 (UMLS CUI [5,3])
C0013227 (UMLS CUI [6,1])
C1521840 (UMLS CUI [6,2])
C0148199 (UMLS CUI [6,3])
C0796392 (UMLS CUI [7])
C1516119 (UMLS CUI [8])
C1700685 (UMLS CUI [9])
C0332155 (UMLS CUI [1,2])
C0021083 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C0199975 (UMLS CUI [3])
C0279030 (UMLS CUI [4])
C0013227 (UMLS CUI [5,1])
C1521840 (UMLS CUI [5,2])
C1256770 (UMLS CUI [5,3])
C0013227 (UMLS CUI [6,1])
C1521840 (UMLS CUI [6,2])
C0148199 (UMLS CUI [6,3])
C0796392 (UMLS CUI [7])
C1516119 (UMLS CUI [8])
C1700685 (UMLS CUI [9])
ECOG performance status
Item
ecog performance status of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy ≥3 months
boolean
C0023671 (UMLS CUI [1])
Organ function | Bone Marrow function
Item
adequate organ and marrow function
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
Malignant Neoplasms Other Absent
Item
no other malignancies within 5 years
boolean
C0006826 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Informed Consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
Therapeutic radiology procedure Bone Marrow Percentage | XL999
Item
radiation to ≥25% of bone marrow within 30 days of xl999 treatment
boolean
C1522449 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C1541529 (UMLS CUI [2])
C0005953 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C1541529 (UMLS CUI [2])
cancer treatment Systemic | XL999
Item
subjects who have received systemic anticancer therapy within 30 days of xl999 treatment
boolean
C0920425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C1541529 (UMLS CUI [2])
C0205373 (UMLS CUI [1,2])
C1541529 (UMLS CUI [2])
Pharmaceutical Preparations Resulting in Adverse event CTCAE Grades | Recovery Absent
Item
subjects who have not recovered to grade ≤1 or to within 10% of baseline from adverse events due to medications administered >30 days prior to study enrollment
boolean
C0013227 (UMLS CUI [1,1])
C0332294 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C1516728 (UMLS CUI [1,4])
C2004454 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0332294 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C1516728 (UMLS CUI [1,4])
C2004454 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Metastatic malignant neoplasm to brain | Compression of spinal cord | Meningeal Carcinomatosis
Item
history of or known brain metastases, current spinal cord compression or carcinomatous meningitis
boolean
C0220650 (UMLS CUI [1])
C0037926 (UMLS CUI [2])
C0220654 (UMLS CUI [3])
C0037926 (UMLS CUI [2])
C0220654 (UMLS CUI [3])
Illness Uncontrolled | Comorbidity
Item
uncontrolled and/or intercurrent illness
boolean
C0221423 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009488 (UMLS CUI [2])
C0205318 (UMLS CUI [1,2])
C0009488 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
pregnant or breastfeeding females
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0006147 (UMLS CUI [2])
HIV Infection
Item
known hiv
boolean
C0019693 (UMLS CUI [1])