ID

34479

Description

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

Keywords

  1. 1/17/19 1/17/19 -
  2. 5/22/19 5/22/19 -
Copyright Holder

GSK group of companies

Uploaded on

January 17, 2019

DOI

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License

Creative Commons BY-NC 3.0

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Eligibility Prostate Cancer NCT01784757

Eligibility Prostate Cancer NCT01784757

Inclusion Criteria
Description

Inclusion Criteria

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

ID.1

Data type

boolean

histologically confirmed adenocarcinoma of prostate
Description

ID.2

Data type

boolean

progressive metastatic disease
Description

ID.3

Data type

boolean

ongoing androgen deprivation therapy with a luteinising hormone-releasing hormone (lhrh) analogue or antagonist or bilateral orchiectomy
Description

ID.4

Data type

boolean

adequate bone marrow, hepatic and renal function
Description

ID.5

Data type

boolean

able to swallow the odm-201 whole as a capsule or tablet.
Description

ID.6

Data type

boolean

Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous chemotherapy for prostate cancer.
Description

ID.7

Data type

boolean

known metastases in the brain.
Description

ID.8

Data type

boolean

history of other malignancy within the previous 5 years, except a basal cell carcinoma of skin.
Description

ID.9

Data type

boolean

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

ID.10

Data type

boolean

Similar models

Eligibility Prostate Cancer NCT01784757

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
written informed consent (ic) obtained.
boolean
ID.2
Item
histologically confirmed adenocarcinoma of prostate
boolean
ID.3
Item
progressive metastatic disease
boolean
ID.4
Item
ongoing androgen deprivation therapy with a luteinising hormone-releasing hormone (lhrh) analogue or antagonist or bilateral orchiectomy
boolean
ID.5
Item
adequate bone marrow, hepatic and renal function
boolean
ID.6
Item
able to swallow the odm-201 whole as a capsule or tablet.
boolean
Item Group
C0680251 (UMLS CUI)
ID.7
Item
previous chemotherapy for prostate cancer.
boolean
ID.8
Item
known metastases in the brain.
boolean
ID.9
Item
history of other malignancy within the previous 5 years, except a basal cell carcinoma of skin.
boolean
ID.10
Item
known gastrointestinal condition that can significantly affect the absorption of the study treatment.
boolean

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