ID

44494

Descrição

A Phase I/II Study of HE3235 in Patients With Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00716794

Link

https://clinicaltrials.gov/show/NCT00716794

Palavras-chave

Versões (2)
  1. 08/09/2018 08/09/2018 -
  2. 27/09/2021 27/09/2021 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

27 de setembro de 2021

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00716794

Inglês

Eligibility Prostate Cancer NCT00716794

1 Formulários  
Criteria
Descrição

Criteria

patient is male and at least 18 years of age, at the time of screening;
Descrição

Gender | Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
patient has metastatic disease (any t, any n, m1);
Descrição

Neoplasm Metastasis TNM clinical staging

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C3258246
patient has failed at least 1 taxane regimen; or patient has symptomatic or asymptomatic crpc and is chemotherapy-naïve
Descrição

Taxane Regimen Quantity failed | CRPC Symptomatic | CRPC Asymptomatic | Chemotherapy naive

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0215136
UMLS CUI [1,2]
C0040808
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0231175
UMLS CUI [2,1]
C1328504
UMLS CUI [2,2]
C0231220
UMLS CUI [3,1]
C1328504
UMLS CUI [3,2]
C0231221
UMLS CUI [4,1]
C0392920
UMLS CUI [4,2]
C0919936
patient has histologically or cytologically confirmed adenocarcinoma of the prostate;
Descrição

Adenocarcinoma of prostate

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0007112
patient has progression of disease despite adequate hormone therapy, demonstrated by one of the following:
Descrição

Disease Progression | Hormone Therapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2]
C0279025
psa level of at least 2 ng/ml that has risen on at least 2 successive occasions, at least 1 week apart.
Descrição

Prostate specific antigen measurement | Raised prostate specific antigen Quantity

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0201544
UMLS CUI [2,1]
C0178415
UMLS CUI [2,2]
C1265611
evaluable disease progression by modified recist (response evaluation criteria in solid tumors) criteria;
Descrição

Evaluable Disease Progression

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1516986
UMLS CUI [1,2]
C0242656
progression of metastatic bone disease on bone scan with > 2 new lesions
Descrição

Secondary malignant neoplasm of bone Progression Bone scan | Lesion New Quantity Bone scan

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0153690
UMLS CUI [1,2]
C0449258
UMLS CUI [1,3]
C0203668
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C0205314
UMLS CUI [2,3]
C1265611
UMLS CUI [2,4]
C0203668
patient has ecog (eastern cooperative oncology group) performance status of 0-2;
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
main exclusion criteria:
Descrição

Exclusion Criteria Main

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
patient has symptomatic parenchymal brain metastases or active epidural disease requiring whole-brain irradiation treated epidural disease is allowed
Descrição

Metastatic malignant neoplasm to brain Parenchymal Symptomatic | Epidural space Disease Requirement Whole brain radiation therapy | Epidural space Disease Treated allowed

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C4277702
UMLS CUI [1,3]
C0231220
UMLS CUI [2,1]
C0228134
UMLS CUI [2,2]
C0012634
UMLS CUI [2,3]
C1514873
UMLS CUI [2,4]
C1520143
UMLS CUI [3,1]
C0228134
UMLS CUI [3,2]
C0012634
UMLS CUI [3,3]
C1522326
UMLS CUI [3,4]
C0683607
patient has active infection;
Descrição

Communicable Disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009450
patient having a history of clinically significant cardiovascular disease (such as chf), clinically significant hepatic, respiratory or renal abnormalities;
Descrição

Cardiovascular Disease | Congestive heart failure | Liver Dysfunction | Respiratory abnormality | Abnormal renal function

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0018802
UMLS CUI [3]
C0086565
UMLS CUI [4]
C4018871
UMLS CUI [5]
C0151746
patient who has any clinically significant abnormalities in laboratory results at screening
Descrição

Laboratory test result abnormal

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0438215
patient who has a history of clinically significant neurological or psychiatric condition;
Descrição

Nervous system disorder | Mental condition Clinical Significance

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0027765
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C2826293
additional criteria are applicable to expansion cohorts.
Descrição

Criteria Additional | Cohort Expanded

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1524062
UMLS CUI [2,1]
C0599755
UMLS CUI [2,2]
C0205229
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Similar models

Eligibility Prostate Cancer NCT00716794

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Gender | Age
Item
patient is male and at least 18 years of age, at the time of screening;
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Neoplasm Metastasis TNM clinical staging
Item
patient has metastatic disease (any t, any n, m1);
boolean
C0027627 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Taxane Regimen Quantity failed | CRPC Symptomatic | CRPC Asymptomatic | Chemotherapy naive
Item
patient has failed at least 1 taxane regimen; or patient has symptomatic or asymptomatic crpc and is chemotherapy-naïve
boolean
C0215136 (UMLS CUI [1,1])
C0040808 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0231175 (UMLS CUI [1,4])
C1328504 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C1328504 (UMLS CUI [3,1])
C0231221 (UMLS CUI [3,2])
C0392920 (UMLS CUI [4,1])
C0919936 (UMLS CUI [4,2])
Adenocarcinoma of prostate
Item
patient has histologically or cytologically confirmed adenocarcinoma of the prostate;
boolean
C0007112 (UMLS CUI [1])
Disease Progression | Hormone Therapy
Item
patient has progression of disease despite adequate hormone therapy, demonstrated by one of the following:
boolean
C0242656 (UMLS CUI [1])
C0279025 (UMLS CUI [2])
Prostate specific antigen measurement | Raised prostate specific antigen Quantity
Item
psa level of at least 2 ng/ml that has risen on at least 2 successive occasions, at least 1 week apart.
boolean
C0201544 (UMLS CUI [1])
C0178415 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Evaluable Disease Progression
Item
evaluable disease progression by modified recist (response evaluation criteria in solid tumors) criteria;
boolean
C1516986 (UMLS CUI [1,1])
C0242656 (UMLS CUI [1,2])
Secondary malignant neoplasm of bone Progression Bone scan | Lesion New Quantity Bone scan
Item
progression of metastatic bone disease on bone scan with > 2 new lesions
boolean
C0153690 (UMLS CUI [1,1])
C0449258 (UMLS CUI [1,2])
C0203668 (UMLS CUI [1,3])
C0221198 (UMLS CUI [2,1])
C0205314 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0203668 (UMLS CUI [2,4])
ECOG performance status
Item
patient has ecog (eastern cooperative oncology group) performance status of 0-2;
boolean
C1520224 (UMLS CUI [1])
Exclusion Criteria Main
Item
main exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Metastatic malignant neoplasm to brain Parenchymal Symptomatic | Epidural space Disease Requirement Whole brain radiation therapy | Epidural space Disease Treated allowed
Item
patient has symptomatic parenchymal brain metastases or active epidural disease requiring whole-brain irradiation treated epidural disease is allowed
boolean
C0220650 (UMLS CUI [1,1])
C4277702 (UMLS CUI [1,2])
C0231220 (UMLS CUI [1,3])
C0228134 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C1514873 (UMLS CUI [2,3])
C1520143 (UMLS CUI [2,4])
C0228134 (UMLS CUI [3,1])
C0012634 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C0683607 (UMLS CUI [3,4])
Communicable Disease
Item
patient has active infection;
boolean
C0009450 (UMLS CUI [1])
Cardiovascular Disease | Congestive heart failure | Liver Dysfunction | Respiratory abnormality | Abnormal renal function
Item
patient having a history of clinically significant cardiovascular disease (such as chf), clinically significant hepatic, respiratory or renal abnormalities;
boolean
C0007222 (UMLS CUI [1])
C0018802 (UMLS CUI [2])
C0086565 (UMLS CUI [3])
C4018871 (UMLS CUI [4])
C0151746 (UMLS CUI [5])
Laboratory test result abnormal
Item
patient who has any clinically significant abnormalities in laboratory results at screening
boolean
C0438215 (UMLS CUI [1])
Nervous system disorder | Mental condition Clinical Significance
Item
patient who has a history of clinically significant neurological or psychiatric condition;
boolean
C0027765 (UMLS CUI [1])
C3840291 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
Criteria Additional | Cohort Expanded
Item
additional criteria are applicable to expansion cohorts.
boolean
C0243161 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
C0599755 (UMLS CUI [2,1])
C0205229 (UMLS CUI [2,2])
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