ID

31656

Description

Window Study of ZD4054 in Metastatic Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01168141

Link

https://clinicaltrials.gov/show/NCT01168141

Keywords

Versions (1)
  1. 9/17/18 9/17/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 17, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT01168141

English

Eligibility Prostate Cancer NCT01168141

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histological confirmation of prostate adenocarcinoma
Description

Adenocarcinoma of prostate

Data type

boolean

Alias
UMLS CUI [1]
C0007112
documented evidence of bone metastasis on bone scan or mri
Description

Secondary malignant neoplasm of bone Bone scan | Secondary malignant neoplasm of bone MRI

Data type

boolean

Alias
UMLS CUI [1,1]
C0153690
UMLS CUI [1,2]
C0203668
UMLS CUI [2,1]
C0153690
UMLS CUI [2,2]
C0024485
biochemical progression of prostate cancer
Description

Prostate carcinoma Progression Biochemical

Data type

boolean

Alias
UMLS CUI [1,1]
C0600139
UMLS CUI [1,2]
C0242656
UMLS CUI [1,3]
C0205474
surgically or medically castrate with serum testosterone ≤2.4nmol/l
Description

Male Castration | Medical Castration | Serum testosterone measurement

Data type

boolean

Alias
UMLS CUI [1]
C0007347
UMLS CUI [2]
C1513054
UMLS CUI [3]
C0428413
ecog performance status 0 - 2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy of 6 months or more.
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
radiotherapy to bone lesion or prostatic bed within 4 weeks of starting study treatment.
Description

Therapeutic radiology procedure Bone lesion | Therapeutic radiology procedure Prostate Bed

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0238792
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C2983573
prior targeted cancer therapies (such as gefitinib, bevacizumab)
Description

Targeted cancer therapy | gefitinib | bevacizumab

Data type

boolean

Alias
UMLS CUI [1]
C3854476
UMLS CUI [2]
C1122962
UMLS CUI [3]
C0796392
systemic radionuclide therapy within 12 weeks of starting study treatment.
Description

Radionuclide therapy Systemic

Data type

boolean

Alias
UMLS CUI [1,1]
C0203608
UMLS CUI [1,2]
C0205373
current therapy, within 4 weeks of study entry with potent inhibitors of cyp3a4 (ketoconazole, itraconazole, ritonavir, indinavir, erythromycin, troleandomycin, clarithromycin, diltiazem and verapamil), inhibitors of cyps 2d6 and 2c9 (quinidine and fluconazole), and potent p450 inducers (phenytoin, rifampicin, carbamazepine and phenobarbitone)
Description

CYP3A4 Inhibitors | Ketoconazole | Itraconazole | Ritonavir | Indinavir | Erythromycin | Troleandomycin | Clarithromycin | Diltiazem | Verapamil | CYP2D6 Inhibitors | CYP2C9 Inhibitors | Quinidine | Fluconazole | Cytochrome P450 Inducer | Phenytoin | Rifampin | Carbamazepine | Phenobarbital

Data type

boolean

Alias
UMLS CUI [1]
C3850053
UMLS CUI [2]
C0022625
UMLS CUI [3]
C0064113
UMLS CUI [4]
C0292818
UMLS CUI [5]
C0376637
UMLS CUI [6]
C0014806
UMLS CUI [7]
C0041165
UMLS CUI [8]
C0055856
UMLS CUI [9]
C0012373
UMLS CUI [10]
C0042523
UMLS CUI [11]
C3850058
UMLS CUI [12]
C3850060
UMLS CUI [13]
C0034414
UMLS CUI [14]
C0016277
UMLS CUI [15,1]
C0010762
UMLS CUI [15,2]
C3898767
UMLS CUI [16]
C0031507
UMLS CUI [17]
C0035608
UMLS CUI [18]
C0006949
UMLS CUI [19]
C0031412
definite or suspected personal history or family history of adverse drug reactions, or hypersensitivity to drugs that are endothelin antagonists
Description

Medical History Adverse reaction to drug | Family history Adverse reaction to drug | Medical History Adverse reaction to drug Suspected | Family history Adverse reaction to drug Suspected | Hypersensitivity Endothelin antagonist

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0041755
UMLS CUI [2,1]
C0241889
UMLS CUI [2,2]
C0041755
UMLS CUI [3,1]
C0262926
UMLS CUI [3,2]
C0041755
UMLS CUI [3,3]
C0750491
UMLS CUI [4,1]
C0241889
UMLS CUI [4,2]
C0041755
UMLS CUI [4,3]
C0750491
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C1134681
ineligibility for mri scanning includes standard mri criteria (for example, metal implants such as cochlear implants, cardiac pacemakers, heart valves, aneurysm clips and metal fragments in eyes) and patients known to be allergic to gadolinium-based mri contrast agents
Description

Ineligibility MRI scan | Metallic implant | Cochlear Implants | Artificial cardiac pacemaker | Heart Valve | Aneurysm clip | Metal foreign body in eye region | Hypersensitivity Gadolinium-based Contrast Agent MRI

Data type

boolean

Alias
UMLS CUI [1,1]
C1512714
UMLS CUI [1,2]
C0024485
UMLS CUI [2]
C3693688
UMLS CUI [3]
C0009199
UMLS CUI [4]
C0030163
UMLS CUI [5]
C0018825
UMLS CUI [6]
C0179977
UMLS CUI [7]
C0562528
UMLS CUI [8,1]
C0020517
UMLS CUI [8,2]
C3249258
UMLS CUI [8,3]
C0024485
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Similar models

Eligibility Prostate Cancer NCT01168141

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of prostate
Item
histological confirmation of prostate adenocarcinoma
boolean
C0007112 (UMLS CUI [1])
Secondary malignant neoplasm of bone Bone scan | Secondary malignant neoplasm of bone MRI
Item
documented evidence of bone metastasis on bone scan or mri
boolean
C0153690 (UMLS CUI [1,1])
C0203668 (UMLS CUI [1,2])
C0153690 (UMLS CUI [2,1])
C0024485 (UMLS CUI [2,2])
Prostate carcinoma Progression Biochemical
Item
biochemical progression of prostate cancer
boolean
C0600139 (UMLS CUI [1,1])
C0242656 (UMLS CUI [1,2])
C0205474 (UMLS CUI [1,3])
Male Castration | Medical Castration | Serum testosterone measurement
Item
surgically or medically castrate with serum testosterone ≤2.4nmol/l
boolean
C0007347 (UMLS CUI [1])
C1513054 (UMLS CUI [2])
C0428413 (UMLS CUI [3])
ECOG performance status
Item
ecog performance status 0 - 2
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of 6 months or more.
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Therapeutic radiology procedure Bone lesion | Therapeutic radiology procedure Prostate Bed
Item
radiotherapy to bone lesion or prostatic bed within 4 weeks of starting study treatment.
boolean
C1522449 (UMLS CUI [1,1])
C0238792 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C2983573 (UMLS CUI [2,2])
Targeted cancer therapy | gefitinib | bevacizumab
Item
prior targeted cancer therapies (such as gefitinib, bevacizumab)
boolean
C3854476 (UMLS CUI [1])
C1122962 (UMLS CUI [2])
C0796392 (UMLS CUI [3])
Radionuclide therapy Systemic
Item
systemic radionuclide therapy within 12 weeks of starting study treatment.
boolean
C0203608 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
CYP3A4 Inhibitors | Ketoconazole | Itraconazole | Ritonavir | Indinavir | Erythromycin | Troleandomycin | Clarithromycin | Diltiazem | Verapamil | CYP2D6 Inhibitors | CYP2C9 Inhibitors | Quinidine | Fluconazole | Cytochrome P450 Inducer | Phenytoin | Rifampin | Carbamazepine | Phenobarbital
Item
current therapy, within 4 weeks of study entry with potent inhibitors of cyp3a4 (ketoconazole, itraconazole, ritonavir, indinavir, erythromycin, troleandomycin, clarithromycin, diltiazem and verapamil), inhibitors of cyps 2d6 and 2c9 (quinidine and fluconazole), and potent p450 inducers (phenytoin, rifampicin, carbamazepine and phenobarbitone)
boolean
C3850053 (UMLS CUI [1])
C0022625 (UMLS CUI [2])
C0064113 (UMLS CUI [3])
C0292818 (UMLS CUI [4])
C0376637 (UMLS CUI [5])
C0014806 (UMLS CUI [6])
C0041165 (UMLS CUI [7])
C0055856 (UMLS CUI [8])
C0012373 (UMLS CUI [9])
C0042523 (UMLS CUI [10])
C3850058 (UMLS CUI [11])
C3850060 (UMLS CUI [12])
C0034414 (UMLS CUI [13])
C0016277 (UMLS CUI [14])
C0010762 (UMLS CUI [15,1])
C3898767 (UMLS CUI [15,2])
C0031507 (UMLS CUI [16])
C0035608 (UMLS CUI [17])
C0006949 (UMLS CUI [18])
C0031412 (UMLS CUI [19])
Medical History Adverse reaction to drug | Family history Adverse reaction to drug | Medical History Adverse reaction to drug Suspected | Family history Adverse reaction to drug Suspected | Hypersensitivity Endothelin antagonist
Item
definite or suspected personal history or family history of adverse drug reactions, or hypersensitivity to drugs that are endothelin antagonists
boolean
C0262926 (UMLS CUI [1,1])
C0041755 (UMLS CUI [1,2])
C0241889 (UMLS CUI [2,1])
C0041755 (UMLS CUI [2,2])
C0262926 (UMLS CUI [3,1])
C0041755 (UMLS CUI [3,2])
C0750491 (UMLS CUI [3,3])
C0241889 (UMLS CUI [4,1])
C0041755 (UMLS CUI [4,2])
C0750491 (UMLS CUI [4,3])
C0020517 (UMLS CUI [5,1])
C1134681 (UMLS CUI [5,2])
Ineligibility MRI scan | Metallic implant | Cochlear Implants | Artificial cardiac pacemaker | Heart Valve | Aneurysm clip | Metal foreign body in eye region | Hypersensitivity Gadolinium-based Contrast Agent MRI
Item
ineligibility for mri scanning includes standard mri criteria (for example, metal implants such as cochlear implants, cardiac pacemakers, heart valves, aneurysm clips and metal fragments in eyes) and patients known to be allergic to gadolinium-based mri contrast agents
boolean
C1512714 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C3693688 (UMLS CUI [2])
C0009199 (UMLS CUI [3])
C0030163 (UMLS CUI [4])
C0018825 (UMLS CUI [5])
C0179977 (UMLS CUI [6])
C0562528 (UMLS CUI [7])
C0020517 (UMLS CUI [8,1])
C3249258 (UMLS CUI [8,2])
C0024485 (UMLS CUI [8,3])
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