ID

31635

Description

ARMOR1: Study of TOK-001 to Treat Castration Resistant Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00959959

Link

https://clinicaltrials.gov/show/NCT00959959

Keywords

Versions (1)
  1. 9/14/18 9/14/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 14, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00959959

English

Eligibility Prostate Cancer NCT00959959

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
signed informed consent form
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
confirmed cancer of the prostate
Description

Prostate carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0600139
progressing disease in spite of androgen ablation therapy
Description

Disease Progression | Androgen ablation Resistant

Data type

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2,1]
C1515985
UMLS CUI [2,2]
C0332325
able to swallow multiple capsules
Description

Able to swallow capsule multiple

Data type

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0006935
UMLS CUI [1,3]
C0439064
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
participation in another clinical trial < 4 weeks prior to enrollment
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
metastatic disease with one or more of the following:
Description

Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1]
C0027627
liver involvement
Description

Liver Involvement

Data type

boolean

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C1314939
bone pain associated with confirmed evidence of metastases
Description

Bone pain Associated with Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1,1]
C0151825
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0027627
non-hepatic visceral involvement
Description

Involvement Visceral Extrahepatic

Data type

boolean

Alias
UMLS CUI [1,1]
C1314939
UMLS CUI [1,2]
C0442045
UMLS CUI [1,3]
C1517058
the following medications:
Description

Pharmaceutical Preparations Specified

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0205369
prior treatment with mdv3100, abiraterone, provenge or tak700
Description

MDV 3100 | abiraterone | Provenge | TAK-700

Data type

boolean

Alias
UMLS CUI [1]
C2348174
UMLS CUI [2]
C0754011
UMLS CUI [3]
C1135133
UMLS CUI [4]
C3467983
prior treatment with ketoconazole
Description

Ketoconazole

Data type

boolean

Alias
UMLS CUI [1]
C0022625
prior treatment with chemotherapy
Description

Prior Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C1514457
prior radiation therapy completed ≤ 4 weeks prior to enrollment
Description

Prior radiation therapy

Data type

boolean

Alias
UMLS CUI [1]
C0279134
the following medical conditions:
Description

Medical condition Specified

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205369
active angina pectoris
Description

Angina Pectoris

Data type

boolean

Alias
UMLS CUI [1]
C0002962
history of hepatitis b or hepatitis c
Description

Hepatitis B | Hepatitis C

Data type

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
known hiv infection
Description

HIV Infection

Data type

boolean

Alias
UMLS CUI [1]
C0019693
ongoing hypertension
Description

Hypertensive disease

Data type

boolean

Alias
UMLS CUI [1]
C0020538
note: there are additional inclusion and exclusion criteria. the clinical site center will determine if you are eligible. if you are not eligible for the trial, site staff will detail the reasons to you.
Description

Eligibility Criteria Additional

Data type

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C1524062
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Similar models

Eligibility Prostate Cancer NCT00959959

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
signed informed consent form
boolean
C0021430 (UMLS CUI [1])
Prostate carcinoma
Item
confirmed cancer of the prostate
boolean
C0600139 (UMLS CUI [1])
Disease Progression | Androgen ablation Resistant
Item
progressing disease in spite of androgen ablation therapy
boolean
C0242656 (UMLS CUI [1])
C1515985 (UMLS CUI [2,1])
C0332325 (UMLS CUI [2,2])
Able to swallow capsule multiple
Item
able to swallow multiple capsules
boolean
C2712086 (UMLS CUI [1,1])
C0006935 (UMLS CUI [1,2])
C0439064 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status
Item
participation in another clinical trial < 4 weeks prior to enrollment
boolean
C2348568 (UMLS CUI [1])
Neoplasm Metastasis
Item
metastatic disease with one or more of the following:
boolean
C0027627 (UMLS CUI [1])
Liver Involvement
Item
liver involvement
boolean
C0023884 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
Bone pain Associated with Neoplasm Metastasis
Item
bone pain associated with confirmed evidence of metastases
boolean
C0151825 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
Involvement Visceral Extrahepatic
Item
non-hepatic visceral involvement
boolean
C1314939 (UMLS CUI [1,1])
C0442045 (UMLS CUI [1,2])
C1517058 (UMLS CUI [1,3])
Pharmaceutical Preparations Specified
Item
the following medications:
boolean
C0013227 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
MDV 3100 | abiraterone | Provenge | TAK-700
Item
prior treatment with mdv3100, abiraterone, provenge or tak700
boolean
C2348174 (UMLS CUI [1])
C0754011 (UMLS CUI [2])
C1135133 (UMLS CUI [3])
C3467983 (UMLS CUI [4])
Ketoconazole
Item
prior treatment with ketoconazole
boolean
C0022625 (UMLS CUI [1])
Prior Chemotherapy
Item
prior treatment with chemotherapy
boolean
C1514457 (UMLS CUI [1])
Prior radiation therapy
Item
prior radiation therapy completed ≤ 4 weeks prior to enrollment
boolean
C0279134 (UMLS CUI [1])
Medical condition Specified
Item
the following medical conditions:
boolean
C3843040 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
Angina Pectoris
Item
active angina pectoris
boolean
C0002962 (UMLS CUI [1])
Hepatitis B | Hepatitis C
Item
history of hepatitis b or hepatitis c
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
HIV Infection
Item
known hiv infection
boolean
C0019693 (UMLS CUI [1])
Hypertensive disease
Item
ongoing hypertension
boolean
C0020538 (UMLS CUI [1])
Eligibility Criteria Additional
Item
note: there are additional inclusion and exclusion criteria. the clinical site center will determine if you are eligible. if you are not eligible for the trial, site staff will detail the reasons to you.
boolean
C1516637 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
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