ID

31601

Description

A Study to Determine the Maximum Tolerated Dose of Elesclomol Sodium Given With a Fixed Dose of Docetaxel and Prednisone in Patients With Metastatic Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00808418

Link

https://clinicaltrials.gov/show/NCT00808418

Keywords

  1. 9/11/18 9/11/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 11, 2018

DOI

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License

Creative Commons BY 4.0

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Eligibility Prostate Cancer NCT00808418

Eligibility Prostate Cancer NCT00808418

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
confirmed metastatic prostate cancer
Description

Secondary malignant neoplasm of prostate

Data type

boolean

Alias
UMLS CUI [1]
C0347001
no more than one prior chemotherapy on which the disease progressed
Description

Prior Chemotherapy Quantity | Disease Progression

Data type

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C1265611
UMLS CUI [2]
C0242656
ecog performance status of less than or equal to 2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
adequate bone marrow, renal and hepatic functions as defined in the protocol
Description

Bone Marrow function | Renal function | Liver function

Data type

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
neuropathy less than or equal to 2
Description

Neuropathy CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1,1]
C0442874
UMLS CUI [1,2]
C1516728
reliable venous access for frequent study drug infusions
Description

Venous access patent | Investigational New Drug Infusion Frequent

Data type

boolean

Alias
UMLS CUI [1]
C3164222
UMLS CUI [2,1]
C0013230
UMLS CUI [2,2]
C0392877
UMLS CUI [2,3]
C0332183
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
significant cardiovascular disease
Description

Cardiovascular Disease

Data type

boolean

Alias
UMLS CUI [1]
C0007222
known active brain metastases
Description

Metastatic malignant neoplasm to brain

Data type

boolean

Alias
UMLS CUI [1]
C0220650
subjects that have received treatment for other malignancies with in the past 5 years
Description

Therapeutic procedure Cancer Other

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1707251
other clinically significant uncontrolled conditions
Description

Condition Uncontrolled Clinical Significance

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0205318
UMLS CUI [1,3]
C2826293

Similar models

Eligibility Prostate Cancer NCT00808418

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Secondary malignant neoplasm of prostate
Item
confirmed metastatic prostate cancer
boolean
C0347001 (UMLS CUI [1])
Prior Chemotherapy Quantity | Disease Progression
Item
no more than one prior chemotherapy on which the disease progressed
boolean
C1514457 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0242656 (UMLS CUI [2])
ECOG performance status
Item
ecog performance status of less than or equal to 2
boolean
C1520224 (UMLS CUI [1])
Bone Marrow function | Renal function | Liver function
Item
adequate bone marrow, renal and hepatic functions as defined in the protocol
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
Neuropathy CTCAE Grades
Item
neuropathy less than or equal to 2
boolean
C0442874 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Venous access patent | Investigational New Drug Infusion Frequent
Item
reliable venous access for frequent study drug infusions
boolean
C3164222 (UMLS CUI [1])
C0013230 (UMLS CUI [2,1])
C0392877 (UMLS CUI [2,2])
C0332183 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Cardiovascular Disease
Item
significant cardiovascular disease
boolean
C0007222 (UMLS CUI [1])
Metastatic malignant neoplasm to brain
Item
known active brain metastases
boolean
C0220650 (UMLS CUI [1])
Therapeutic procedure Cancer Other
Item
subjects that have received treatment for other malignancies with in the past 5 years
boolean
C0087111 (UMLS CUI [1,1])
C1707251 (UMLS CUI [1,2])
Condition Uncontrolled Clinical Significance
Item
other clinically significant uncontrolled conditions
boolean
C0348080 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])

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