ID

20190

Description

Study of XL999 in Patients With Metastatic Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00277303

Link

https://clinicaltrials.gov/show/NCT00277303

Keywords

Versions (1)
  1. 11/02/2017 11/02/2017 -
Uploaded on

11 février 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Colorectal Cancer NCT00277303

English

Eligibility Colorectal Cancer NCT00277303

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
males and females with histologically confirmed metastatic colorectal cancer
Description

Gender | Colorectal cancer metastatic

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0948380
measurable disease according to response criteria for solid tumors (recist)
Description

Measurable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
at least 1 prior therapeutic regimen (chemotherapy or biologic)
Description

Chemotherapy Regimen Quantity | Biological treatment Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C1531518
UMLS CUI [2,2]
C1265611
ecog performance status of 0 or 1
Description

ECOG performance status

Data type

boolean

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

Life Expectancy

Data type

boolean

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

Organ function | Bone Marrow function

Data type

boolean

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

Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0006826
signed informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

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

Therapeutic radiology procedure Bone Marrow Percentage | XL999

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0005953
UMLS CUI [1,3]
C0439165
UMLS CUI [2]
C1541529
treatment with systemic anticancer therapy within 30 days of xl999 treatment
Description

cancer treatment Systemic | XL999

Data type

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205373
UMLS CUI [2]
C1541529
subject has not recovered to ≤ grade 1 or to within 10% of baseline from adverse events due to other medications administered >30 days prior to study enrollment
Description

Adverse reaction to drug | Study Subject Recovered CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1]
C0041755
UMLS CUI [2,1]
C0681850
UMLS CUI [2,2]
C0521108
UMLS CUI [2,3]
C1516728
history of or known brain metastases, current spinal cord compression, or carcinomatous meningitis
Description

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

Data type

boolean

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

Illness Uncontrolled | Intercurrent disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0277557
pregnant or breastfeeding females
Description

Pregnancy | Breast Feeding

Data type

boolean

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

HIV Infection

Data type

boolean

Alias
UMLS CUI [1]
C0019693
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Similar models

Eligibility Colorectal Cancer NCT00277303

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Colorectal cancer metastatic
Item
males and females with histologically confirmed metastatic colorectal cancer
boolean
C0079399 (UMLS CUI [1])
C0948380 (UMLS CUI [2])
Measurable Disease
Item
measurable disease according to response criteria for solid tumors (recist)
boolean
C1513041 (UMLS CUI [1])
Chemotherapy Regimen Quantity | Biological treatment Quantity
Item
at least 1 prior therapeutic regimen (chemotherapy or biologic)
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1531518 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
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
Item
no other malignancies within 5 years
boolean
C0006826 (UMLS CUI [1])
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
treatment with systemic anticancer therapy within 30 days of xl999 treatment
boolean
C0920425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C1541529 (UMLS CUI [2])
Adverse reaction to drug | Study Subject Recovered CTCAE Grades
Item
subject has not recovered to ≤ grade 1 or to within 10% of baseline from adverse events due to other medications administered >30 days prior to study enrollment
boolean
C0041755 (UMLS CUI [1])
C0681850 (UMLS CUI [2,1])
C0521108 (UMLS CUI [2,2])
C1516728 (UMLS CUI [2,3])
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 | Intercurrent disease
Item
uncontrolled and/or intercurrent illness
boolean
C0221423 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0277557 (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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