ID

22928

Beskrivning

Study of XL999 in Patients With Metastatic Renal Cell Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00277316

Länk

https://clinicaltrials.gov/show/NCT00277316

Nyckelord

Versioner (1)
  1. 2017-06-16 2017-06-16 -
Uppladdad den

16 juni 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Renal Cell Carcinoma NCT00277316

Engelsk

Eligibility Renal Cell Carcinoma NCT00277316

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
males and females with histologically confirmed metastatic clear cell rcc
Beskrivning

Clear-cell metastatic renal cell carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C2931852
measurable disease according to response criteria for solid tumors (recist)
Beskrivning

Measurable Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C1513041
no prior systemic cytotoxic chemotherapy
Beskrivning

Cytotoxic Chemotherapy Systemic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0677881
UMLS CUI [1,2]
C0205373
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
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007134
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C0021083
UMLS CUI [2,2]
C0205373
UMLS CUI [3]
C0199975
UMLS CUI [4]
C0279030
UMLS CUI [5,1]
C0013227
UMLS CUI [5,2]
C1521840
UMLS CUI [5,3]
C1256770
UMLS CUI [6,1]
C0013227
UMLS CUI [6,2]
C1521840
UMLS CUI [6,3]
C0148199
UMLS CUI [7]
C0796392
UMLS CUI [8]
C1516119
UMLS CUI [9]
C1700685
ecog performance status of 0 or 1
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy ≥3 months
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
adequate organ and marrow function
Beskrivning

Organ function | Bone Marrow function

Datatyp

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
no other malignancies within 5 years
Beskrivning

Malignant Neoplasms Other Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0332197
signed informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
radiation to ≥25% of bone marrow within 30 days of xl999 treatment
Beskrivning

Therapeutic radiology procedure Bone Marrow Percentage | XL999

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0005953
UMLS CUI [1,3]
C0439165
UMLS CUI [2]
C1541529
subjects who have received systemic anticancer therapy within 30 days of xl999 treatment
Beskrivning

cancer treatment Systemic | XL999

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205373
UMLS CUI [2]
C1541529
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
Beskrivning

Pharmaceutical Preparations Resulting in Adverse event CTCAE Grades | Recovery Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0332294
UMLS CUI [1,3]
C0877248
UMLS CUI [1,4]
C1516728
UMLS CUI [2,1]
C2004454
UMLS CUI [2,2]
C0332197
history of or known brain metastases, current spinal cord compression or carcinomatous meningitis
Beskrivning

Metastatic malignant neoplasm to brain | Compression of spinal cord | Meningeal Carcinomatosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2]
C0037926
UMLS CUI [3]
C0220654
uncontrolled and/or intercurrent illness
Beskrivning

Illness Uncontrolled | Comorbidity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0009488
pregnant or breastfeeding females
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
known hiv
Beskrivning

HIV Infection

Datatyp

boolean

Alias
UMLS CUI [1]
C0019693
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Similar models

Eligibility Renal Cell Carcinoma NCT00277316

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
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])
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])
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])
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])
Informed Consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
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])
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])
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])
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])
Illness Uncontrolled | Comorbidity
Item
uncontrolled and/or intercurrent illness
boolean
C0221423 (UMLS CUI [1,1])
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])
HIV Infection
Item
known hiv
boolean
C0019693 (UMLS CUI [1])
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