ID

46

Descrizione

Evaluation of Bay 59-8862 in Patients With Advanced Renal Cell Carcinoma Inclusion Criteria: - measurable disease as defined by the presence of at least one measurable lesion - prior immunotherapy (up to 2 regimens) or prior radiotherapy is permitted but at least 4 weeks must have elapsed prior to enter study - life expectancy of at least 12 weeks - adequate bone marrow, liver and kidney function Exclusion Criteria: - excluded medical conditions like: pre-existing neuropathy, active heart diseases or ischemia, serious infections, HIV infection, chronic hepatitis B or C, brain metastasis, seizures, hypersensitivity to taxanes, organ transplants, some previous cancers - excluded therapies and medications, previous and concomitant such as: anticancer chemotherapy or immunotherapy during the study or within 4 weeks prior to study entry; more than two prior anticancer chemotherapy regimens; radiotherapy during study or within 4 weeks prior to study entry; bone marrow transplant - others: pregnant or breast-feeding patients; both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial; substance abuse, medical, psychological or social conditions that may interfere with the patient's participation

Keywords

versioni (4)
  1. 11/11/11 11/11/11 -
  2. 11/11/11 11/11/11 -
  3. 21/03/14 21/03/14 - Martin Dugas
  4. 17/09/21 17/09/21 -
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11 novembre 2011

DOI

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Licenza

Creative Commons BY-NC 3.0 Legacy
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NCT00044564 Evaluation of Bay 59-8862 in Patients With Advanced Renal Cell Carcinoma

Tedesco Inglese

Eligibility

1 moduli  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion criteria
Descrizione

Inclusion criteria

measurable disease as defined by the presence of at least one measurable lesion
Descrizione

Advanced Renal Cell Carcinoma

Tipo di dati

boolean

prior immunotherapy (up to 2 regimens) or prior radiotherapy is permitted but at least 4 weeks must have elapsed prior to enter study
Descrizione

Prior therapy

Tipo di dati

boolean

life expectancy of at least 12 weeks
Descrizione

Life expectancy

Tipo di dati

boolean

adequate bone marrow, liver and kidney function
Descrizione

Bone marrow, liver, kidney

Tipo di dati

boolean

Exclusion criteria
Descrizione

Exclusion criteria

excluded medical conditions like: pre-existing neuropathy, active heart diseases or ischemia, serious infections, HIV infection, chronic hepatitis B or C, brain metastasis, seizures, hypersensitivity to taxanes, organ transplants, some previous cancers
Descrizione

excluded medical conditions

Tipo di dati

boolean

excluded therapies and medications, previous and concomitant such as: anticancer chemotherapy or immunotherapy during the study or within 4 weeks prior to study entry; more than two prior anticancer chemotherapy regimens; radiotherapy during study or within 4 weeks prior to study entry; bone marrow transplant
Descrizione

excluded therapies and medications

Tipo di dati

boolean

others: pregnant or breast-feeding patients; both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial; substance abuse, medical, psychological or social conditions that may interfere with the patient's participation
Descrizione

other exclusion criteria

Tipo di dati

boolean

Medical concepts
Descrizione

Medical concepts

Diagnosis
Descrizione

Diagnosis

Tipo di dati

string

Alias
UMLS CUI
C0011900
SNOMED CT 2010_0731
439401001
Immunotherapy
Descrizione

Immunotherapy

Tipo di dati

string

Alias
UMLS CUI
C0021083
SNOMED CT 2010_0731
146638005
Radiotherapy
Descrizione

Radiotherapy

Tipo di dati

string

Alias
UMLS CUI
C1522449
SNOMED CT 2010_0731
302505005
Life expectancy
Descrizione

Life expectancy

Tipo di dati

string

Alias
UMLS CUI
C0023671
LOINC Version 232
LP75025-4
White blood cell count
Descrizione

WBC

Tipo di dati

string

Alias
SNOMED CT 2010_0731
767002
LOINC
6690-2
Platelet count - finding
Descrizione

Platelet count

Tipo di dati

string

Alias
SNOMED CT 2010_0731
365632008
UMLS CUI
C1287267
LOINC
777-3
Hemoglobin
Descrizione

Hemoglobin

Tipo di dati

string

Alias
SNOMED CT 2010_0731
38082009
UMLS CUI
C0019046
MedDRA 13.1
10019481
LOINC
LP14449-0
International Normalized Ratio of Prothrombin Time
Descrizione

INR

Tipo di dati

string

Alias
UMLS CUI
C0525032
SNOMED CT 2010_0731
165581004
MedDRA 13.1
10022400
LOINC
LP20762-8
Bilirubin
Descrizione

Bilirubin

Tipo di dati

string

Alias
SNOMED CT 2010_0731
79706000
UMLS CUI
C0011221
MedDRA Version 13.1
10004683
LOINC
1975-2
Creatinine
Descrizione

Creatinine

Tipo di dati

string

Alias
UMLS CUI
C0010294
SNOMED CT 2010_0731
15373003
LOINC
38483-4
MedDRA 13.1
10011358
Neuropathy
Descrizione

Neuropathy

Tipo di dati

string

Alias
UMLS CUI
C0442874
SNOMED CT 2010_0731
386033004
MedDRA 13.1
10029328
Heart Disease
Descrizione

Cardiac disease

Tipo di dati

string

Alias
UMLS CUI
C0018799
SNOMED CT 2010_0731
56265001
MedDRA 13.1
10061024
Infection
Descrizione

Infection

Tipo di dati

string

Alias
UMLS CUI
C0021311
SNOMED CT 2010_0731
257551009
MedDRA Version 13.1
10021789
HIV negative
Descrizione

HIV negative

Tipo di dati

string

Alias
UMLS CUI
C0481430
SNOMED CT 2010_0731
143223008
MedDRA 13.1
10020179
Hepatitis
Descrizione

Hepatitis

Tipo di dati

string

Alias
SNOMED CT 2010_0731
29001004
UMLS CUI
C0019158
MedDRA Version 13.1
10019717
LOINC
LP20771-9
Metastatic malignant disease
Descrizione

Metastasis

Tipo di dati

string

Alias
UMLS CUI
C0027627
SNOMED CT 2010_0731
128462008
MedDRA 13.1
10027449
LOINC Version 232
LP35033-7
Hypersensitivity to medication
Descrizione

Allergic reaction, due to correct medicinal substance properly administered

Tipo di dati

string

Alias
UMLS CUI
C0274302
SNOMED CT 2010_0731
57302007
Organ transplant
Descrizione

Organ transplant

Tipo di dati

string

Alias
UMLS CUI
C0029216
MedDRA 13.1
10061890
LOINC Version 232
MTHU000173
Medication
Descrizione

Pharmaceutical Preparations

Tipo di dati

string

Alias
UMLS CUI
C0013227
Cancer chemotherapy
Descrizione

Chemotherapy

Tipo di dati

string

Alias
UMLS CUI
C0392920
SNOMED CT 2010_0731
150415003
Immunomodulatory or immunosuppressive therapy
Descrizione

Immunomodulatory or immunosuppressive therapy

Tipo di dati

string

Alias
SNOMED CT 2010_0731
86553008
UMLS CUI
C1963758
MedDRA Version 13.1
10067473
Radiotherapy
Descrizione

Radiotherapy

Tipo di dati

string

Alias
UMLS CUI
C1522449
SNOMED CT 2010_0731
302505005
pregnant
Descrizione

pregnant

Tipo di dati

string

Alias
UMLS CUI
C0549206
MedDRA 13.1
10036586
Breast feeding
Descrizione

Lactation

Tipo di dati

string

Alias
UMLS CUI
C0006147
MedDRA 13.1
10006247
Contraception
Descrizione

Contraception

Tipo di dati

string

Alias
UMLS CUI
C0700589
SNOMED CT 2010_0731
146680009
MedDRA 13.1
10010808
Drug abuse
Descrizione

Drug abuse

Tipo di dati

string

Alias
UMLS CUI
C0013146
SNOMED CT 2010_0731
26416006
MedDRA 13.1
10013654
LOINC
LP36310-8
ICD-9-CM Version 2011
305.90
Compliance behavior
Descrizione

Compliance

Tipo di dati

string

Alias
UMLS CUI
C1321605
SNOMED CT 2010_0731
405078008
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Similar models

Eligibility

1 moduli
  1. StudyEvent: Eligibility
    1. Eligibility
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Inclusion criteria
Advanced Renal Cell Carcinoma
Item
measurable disease as defined by the presence of at least one measurable lesion
boolean
Prior therapy
Item
prior immunotherapy (up to 2 regimens) or prior radiotherapy is permitted but at least 4 weeks must have elapsed prior to enter study
boolean
Life expectancy
Item
life expectancy of at least 12 weeks
boolean
Bone marrow, liver, kidney
Item
adequate bone marrow, liver and kidney function
boolean
Item Group
Exclusion criteria
excluded medical conditions
Item
excluded medical conditions like: pre-existing neuropathy, active heart diseases or ischemia, serious infections, HIV infection, chronic hepatitis B or C, brain metastasis, seizures, hypersensitivity to taxanes, organ transplants, some previous cancers
boolean
excluded therapies and medications
Item
excluded therapies and medications, previous and concomitant such as: anticancer chemotherapy or immunotherapy during the study or within 4 weeks prior to study entry; more than two prior anticancer chemotherapy regimens; radiotherapy during study or within 4 weeks prior to study entry; bone marrow transplant
boolean
other exclusion criteria
Item
others: pregnant or breast-feeding patients; both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial; substance abuse, medical, psychological or social conditions that may interfere with the patient's participation
boolean
Item Group
Medical concepts
Diagnosis
Item
Diagnosis
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2010_0731)
Immunotherapy
Item
Immunotherapy
string
C0021083 (UMLS CUI)
146638005 (SNOMED CT 2010_0731)
Radiotherapy
Item
Radiotherapy
string
C1522449 (UMLS CUI)
302505005 (SNOMED CT 2010_0731)
Life expectancy
Item
Life expectancy
string
C0023671 (UMLS CUI)
LP75025-4 (LOINC Version 232)
WBC
Item
White blood cell count
string
767002 (SNOMED CT 2010_0731)
6690-2 (LOINC)
Platelet count
Item
Platelet count - finding
string
365632008 (SNOMED CT 2010_0731)
C1287267 (UMLS CUI)
777-3 (LOINC)
Hemoglobin
Item
Hemoglobin
string
38082009 (SNOMED CT 2010_0731)
C0019046 (UMLS CUI)
10019481 (MedDRA 13.1)
LP14449-0 (LOINC)
INR
Item
International Normalized Ratio of Prothrombin Time
string
C0525032 (UMLS CUI)
165581004 (SNOMED CT 2010_0731)
10022400 (MedDRA 13.1)
LP20762-8 (LOINC)
Bilirubin
Item
Bilirubin
string
79706000 (SNOMED CT 2010_0731)
C0011221 (UMLS CUI)
10004683 (MedDRA Version 13.1)
1975-2 (LOINC)
Creatinine
Item
Creatinine
string
C0010294 (UMLS CUI)
15373003 (SNOMED CT 2010_0731)
38483-4 (LOINC)
10011358 (MedDRA 13.1)
Neuropathy
Item
Neuropathy
string
C0442874 (UMLS CUI)
386033004 (SNOMED CT 2010_0731)
10029328 (MedDRA 13.1)
Cardiac disease
Item
Heart Disease
string
C0018799 (UMLS CUI)
56265001 (SNOMED CT 2010_0731)
10061024 (MedDRA 13.1)
Infection
Item
Infection
string
C0021311 (UMLS CUI)
257551009 (SNOMED CT 2010_0731)
10021789 (MedDRA Version 13.1)
HIV negative
Item
HIV negative
string
C0481430 (UMLS CUI)
143223008 (SNOMED CT 2010_0731)
10020179 (MedDRA 13.1)
Hepatitis
Item
Hepatitis
string
29001004 (SNOMED CT 2010_0731)
C0019158 (UMLS CUI)
10019717 (MedDRA Version 13.1)
LP20771-9 (LOINC)
Metastasis
Item
Metastatic malignant disease
string
C0027627 (UMLS CUI)
128462008 (SNOMED CT 2010_0731)
10027449 (MedDRA 13.1)
LP35033-7 (LOINC Version 232)
Allergic reaction, due to correct medicinal substance properly administered
Item
Hypersensitivity to medication
string
C0274302 (UMLS CUI)
57302007 (SNOMED CT 2010_0731)
Organ transplant
Item
Organ transplant
string
C0029216 (UMLS CUI)
10061890 (MedDRA 13.1)
MTHU000173 (LOINC Version 232)
Pharmaceutical Preparations
Item
Medication
string
C0013227 (UMLS CUI)
Chemotherapy
Item
Cancer chemotherapy
string
C0392920 (UMLS CUI)
150415003 (SNOMED CT 2010_0731)
Immunomodulatory or immunosuppressive therapy
Item
Immunomodulatory or immunosuppressive therapy
string
86553008 (SNOMED CT 2010_0731)
C1963758 (UMLS CUI)
10067473 (MedDRA Version 13.1)
Radiotherapy
Item
Radiotherapy
string
C1522449 (UMLS CUI)
302505005 (SNOMED CT 2010_0731)
pregnant
Item
pregnant
string
C0549206 (UMLS CUI)
10036586 (MedDRA 13.1)
Lactation
Item
Breast feeding
string
C0006147 (UMLS CUI)
10006247 (MedDRA 13.1)
Contraception
Item
Contraception
string
C0700589 (UMLS CUI)
146680009 (SNOMED CT 2010_0731)
10010808 (MedDRA 13.1)
Drug abuse
Item
Drug abuse
string
C0013146 (UMLS CUI)
26416006 (SNOMED CT 2010_0731)
10013654 (MedDRA 13.1)
LP36310-8 (LOINC)
305.90 (ICD-9-CM Version 2011)
Compliance
Item
Compliance behavior
string
C1321605 (UMLS CUI)
405078008 (SNOMED CT 2010_0731)
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