ID

36573

Beschrijving

Bioavailability Study of ODM-201 in Subjects With Metastatic Chemotherapy-naive Castration-resistant Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01784757

Link

https://clinicaltrials.gov/show/NCT01784757

Trefwoorden

Versies (2)
  1. 17-01-19 17-01-19 -
  2. 22-05-19 22-05-19 -
Houder van rechten

Orion Corporation, Orion Pharma

Geüploaded op

22 mei 2019

DOI

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Licentie

Creative Commons BY-NC 3.0
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Bioavailability of ODM-201 in Prostate Cancer NCT01784757

Engels

Eligibility Criteria

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
written informed consent (ic) obtained.
Beschrijving

Informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
histologically confirmed adenocarcinoma of prostate
Beschrijving

histologically confirmed adenocarcinoma of prostate

Datatype

boolean

Alias
UMLS CUI [1,1]
C0679557
UMLS CUI [1,2]
C0007112
progressive metastatic disease
Beschrijving

progressive metastatic disease

Datatype

boolean

Alias
UMLS CUI [1,1]
C2939420
UMLS CUI [1,2]
C0205329
ongoing androgen deprivation therapy with a luteinising hormone-releasing hormone (LHRH) analogue or antagonist or bilateral orchiectomy
Beschrijving

ongoing androgen deprivation therapy with LHRH analogue or antagonist or bilateral orchiectomy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0521116
UMLS CUI [1,2]
C0279492
UMLS CUI [1,3]
C1518041
UMLS CUI [2,1]
C0521116
UMLS CUI [2,2]
C0279492
UMLS CUI [2,3]
C1276926
UMLS CUI [3]
C0194875
adequate bone marrow, hepatic and renal function
Beschrijving

adequate bone marrow, hepatic and renal function

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
able to swallow the ODM-201 whole as a capsule or tablet
Beschrijving

able to swallow study treatment as capsule or tablet

Datatype

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0006935
UMLS CUI [2,1]
C2712086
UMLS CUI [2,2]
C0039225
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous chemotherapy for prostate cancer
Beschrijving

previous chemotherapy for prostate cancer

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0600139
known metastases in the brain
Beschrijving

known metastases in the brain

Datatype

boolean

Alias
UMLS CUI [1]
C0220650
history of other malignancy within the previous 5 years, except a basal cell carcinoma of skin
Beschrijving

history of other malignancy, except a basal cell carcinoma of skin

Datatype

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0006826
UMLS CUI [2,1]
C2828389
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1123023
known gastrointestinal condition that can significantly affect the absorption of the study treatment
Beschrijving

known gastrointestinal condition that can significantly affect the absorption of the study treatment

Datatype

boolean

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C0750502
UMLS CUI [1,3]
C0392760
UMLS CUI [1,4]
C0237442
UMLS CUI [1,5]
C0013230
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Similar models

Eligibility Criteria

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Informed consent
Item
written informed consent (ic) obtained.
boolean
C0021430 (UMLS CUI [1])
histologically confirmed adenocarcinoma of prostate
Item
histologically confirmed adenocarcinoma of prostate
boolean
C0679557 (UMLS CUI [1,1])
C0007112 (UMLS CUI [1,2])
progressive metastatic disease
Item
progressive metastatic disease
boolean
C2939420 (UMLS CUI [1,1])
C0205329 (UMLS CUI [1,2])
ongoing androgen deprivation therapy with LHRH analogue or antagonist or bilateral orchiectomy
Item
ongoing androgen deprivation therapy with a luteinising hormone-releasing hormone (LHRH) analogue or antagonist or bilateral orchiectomy
boolean
C0521116 (UMLS CUI [1,1])
C0279492 (UMLS CUI [1,2])
C1518041 (UMLS CUI [1,3])
C0521116 (UMLS CUI [2,1])
C0279492 (UMLS CUI [2,2])
C1276926 (UMLS CUI [2,3])
C0194875 (UMLS CUI [3])
adequate bone marrow, hepatic and renal function
Item
adequate bone marrow, hepatic and renal function
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
able to swallow study treatment as capsule or tablet
Item
able to swallow the ODM-201 whole as a capsule or tablet
boolean
C2712086 (UMLS CUI [1,1])
C0006935 (UMLS CUI [1,2])
C2712086 (UMLS CUI [2,1])
C0039225 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
previous chemotherapy for prostate cancer
Item
previous chemotherapy for prostate cancer
boolean
C1514457 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
known metastases in the brain
Item
known metastases in the brain
boolean
C0220650 (UMLS CUI [1])
history of other malignancy, except a basal cell carcinoma of skin
Item
history of other malignancy within the previous 5 years, except a basal cell carcinoma of skin
boolean
C0262926 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
C2828389 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1123023 (UMLS CUI [2,3])
known gastrointestinal condition that can significantly affect the absorption of the study treatment
Item
known gastrointestinal condition that can significantly affect the absorption of the study treatment
boolean
C0017178 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
C0237442 (UMLS CUI [1,4])
C0013230 (UMLS CUI [1,5])
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