ID

15760

Description

Study Investigating the Pharmacokinetics, Pharmacodynamics and Safety of FE200486; ODM derived from: https://clinicaltrials.gov/show/NCT00117949

Link

https://clinicaltrials.gov/show/NCT00117949

Keywords

Versions (1)
  1. 6/11/16 6/11/16 -
Uploaded on

June 11, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00117949

English

Eligibility Prostate Cancer NCT00117949

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
has given written consent before any study related activity is performed (a study related activity is defined as any procedure that would not have been performed during the normal management of the patient.)
Description

each patient must meet the following inclusion criteria before entry into the study:

Data type

boolean

Alias
UMLS CUI [1]
C0021430
is a male patient with histologically proven adenocarcinoma of the prostate (all stages) in whom endocrine treatment is indicated, except for neoadjuvant hormonal therapy. for patients, prostate-specific antigen (psa) increases on two consecutive determinations at least 2 weeks apart prior to visit 1 must be documented.
Description

adenocarcinoma of the prostate

Data type

boolean

Alias
UMLS CUI [1]
C0007112
is at least 18 years.
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
has an ecog score of 2.
Description

ecog score

Data type

boolean

Alias
UMLS CUI [1]
C1520224
has a baseline testosterone level within the age specific normal range as measured by the central laboratory.
Description

testosterone level

Data type

boolean

Alias
UMLS CUI [1,1]
C0039601
UMLS CUI [1,2]
C1442488
has a psa value of 2 ng/ml as measured by the central laboratory.
Description

psa

Data type

boolean

Alias
UMLS CUI [1]
C0138741
has a life expectancy of at least 6 months.
Description

life expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous or present hormonal management of prostate cancer (surgical castration or other hormonal manipulation, e.g. gnrh agonists, gnrh antagonists, antiandrogens, estrogens, pc-spec) except for neoadjuvant hormonal therapy of < 6 months duration and completed > 6 months prior to visit 1.
Description

any patient meeting one or more of the following exclusion criteria will not be entered into the study:

Data type

boolean

Alias
UMLS CUI [1,1]
C0007112
UMLS CUI [1,2]
C0279025
requires hormonal therapy for neoadjuvant purposes.
Description

hormonal therapy for neoadjuvant purposes

Data type

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C0600558
is recently (within the last 12 weeks preceding visit 1) or presently treated with any other drug modifying the testosterone level or function.
Description

any other drug modifying the testosterone level

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0039601
UMLS CUI [1,3]
C0521102
is considered to be a candidate for curative therapy, i.e., radical prostatectomy or radiotherapy within 6 months after visit 1.
Description

candidate for curative therapy

Data type

boolean

Alias
UMLS CUI [1]
C0194810
UMLS CUI [2]
C1522449
has a history of severe asthma requiring daily treatment with inhalation steroids, angioedema or anaphylactic reactions.
Description

severe asthma

Data type

boolean

Alias
UMLS CUI [1]
C0581126
has hypersensitivity towards any component of the investigational product.
Description

hypersensitivity

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0304229
has had a cancer disease within the last 10 years except for prostate cancer, and surgically removed basocellular or squamous cell carcinoma of the skin.
Description

cancer disease

Data type

boolean

Alias
UMLS CUI [1]
C0006826
has a clinically significant neurologic, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, dermatological or infectious disorder or any other condition, including excessive alcohol or drug abuse, which may interfere with trial participation, or which may affect the conclusion of the study, as judged by the investigator.
Description

comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0038586
any clinically significant laboratory abnormalities which, in the judgment of the investigator, would interfere with the patient's participation in this study or evaluation of study results (liver transaminases must be within normal limits).
Description

significant laboratory abnormalities

Data type

boolean

Alias
UMLS CUI [1]
C1853129
has a mental incapacity or language barrier precluding adequate understanding or co-operation.
Description

mental incapacity or language barrier

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
UMLS CUI [2]
C0237167
has received an investigational drug within the last 12 weeks preceding visit 1.
Description

another investigational drug

Data type

boolean

Alias
UMLS CUI [1]
C2348568
has previously participated in this study.
Description

previously participated

Data type

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Prostate Cancer NCT00117949

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
written consent
Item
has given written consent before any study related activity is performed (a study related activity is defined as any procedure that would not have been performed during the normal management of the patient.)
boolean
C0021430 (UMLS CUI [1])
adenocarcinoma of the prostate
Item
is a male patient with histologically proven adenocarcinoma of the prostate (all stages) in whom endocrine treatment is indicated, except for neoadjuvant hormonal therapy. for patients, prostate-specific antigen (psa) increases on two consecutive determinations at least 2 weeks apart prior to visit 1 must be documented.
boolean
C0007112 (UMLS CUI [1])
age
Item
is at least 18 years.
boolean
C0001779 (UMLS CUI [1])
ecog score
Item
has an ecog score of 2.
boolean
C1520224 (UMLS CUI [1])
testosterone level
Item
has a baseline testosterone level within the age specific normal range as measured by the central laboratory.
boolean
C0039601 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
psa
Item
has a psa value of 2 ng/ml as measured by the central laboratory.
boolean
C0138741 (UMLS CUI [1])
life expectancy
Item
has a life expectancy of at least 6 months.
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
hormonal management of prostate cancer
Item
previous or present hormonal management of prostate cancer (surgical castration or other hormonal manipulation, e.g. gnrh agonists, gnrh antagonists, antiandrogens, estrogens, pc-spec) except for neoadjuvant hormonal therapy of < 6 months duration and completed > 6 months prior to visit 1.
boolean
C0007112 (UMLS CUI [1,1])
C0279025 (UMLS CUI [1,2])
hormonal therapy for neoadjuvant purposes
Item
requires hormonal therapy for neoadjuvant purposes.
boolean
C0279025 (UMLS CUI [1,1])
C0600558 (UMLS CUI [1,2])
any other drug modifying the testosterone level
Item
is recently (within the last 12 weeks preceding visit 1) or presently treated with any other drug modifying the testosterone level or function.
boolean
C0013227 (UMLS CUI [1,1])
C0039601 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
candidate for curative therapy
Item
is considered to be a candidate for curative therapy, i.e., radical prostatectomy or radiotherapy within 6 months after visit 1.
boolean
C0194810 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
severe asthma
Item
has a history of severe asthma requiring daily treatment with inhalation steroids, angioedema or anaphylactic reactions.
boolean
C0581126 (UMLS CUI [1])
hypersensitivity
Item
has hypersensitivity towards any component of the investigational product.
boolean
C0020517 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
cancer disease
Item
has had a cancer disease within the last 10 years except for prostate cancer, and surgically removed basocellular or squamous cell carcinoma of the skin.
boolean
C0006826 (UMLS CUI [1])
comorbidity
Item
has a clinically significant neurologic, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, dermatological or infectious disorder or any other condition, including excessive alcohol or drug abuse, which may interfere with trial participation, or which may affect the conclusion of the study, as judged by the investigator.
boolean
C0009488 (UMLS CUI [1])
C0038586 (UMLS CUI [2])
significant laboratory abnormalities
Item
any clinically significant laboratory abnormalities which, in the judgment of the investigator, would interfere with the patient's participation in this study or evaluation of study results (liver transaminases must be within normal limits).
boolean
C1853129 (UMLS CUI [1])
mental incapacity or language barrier
Item
has a mental incapacity or language barrier precluding adequate understanding or co-operation.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
C0237167 (UMLS CUI [2])
another investigational drug
Item
has received an investigational drug within the last 12 weeks preceding visit 1.
boolean
C2348568 (UMLS CUI [1])
previously participated
Item
has previously participated in this study.
boolean
C2348568 (UMLS CUI [1])
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