ID

42478

Beschreibung

A Study to Evaluate How Daily Dosing With Enzalutamide Affects the Metabolism of Caffeine and Dextromethorphan in Men With Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02225093

Link

https://clinicaltrials.gov/show/NCT02225093

Stichworte

Versionen (1)
  1. 17.07.21 17.07.21 -
Rechteinhaber

Astellas Pharma Europe B.V. Medivation, Inc.

Hochgeladen am

17. Juli 2021

DOI

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Lizenz

Creative Commons BY-NC 4.0
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Eligibility Pharmacokinetics of Caffeine NCT02225093

Englisch

Eligibility Pharmacokinetics of Caffeine NCT02225093

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
subject is a male aged 18 years old or older (at screening) with histologically confirmed prostate cancer (all stages) for whom androgen deprivation therapy is indicated (except when indicated in a neoadjuvant/adjuvant setting). subjects may be on ongoing androgen deprivation therapy with a gonadotropin releasing hormone (gnrh) analogue or have undergone prior bilateral orchiectomy at screening.
Beschreibung

Age, Histologically confirmed prostate cancer, indication of androgen deprivation therapy | Concomitant treatment with gonadotropin releasing hormone (gnrh) analogue possible | Status post bilateral orchiectomy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C0079399
UMLS CUI [1,3]
C0600139
UMLS CUI [1,4]
C0521093
UMLS CUI [1,5]
C0205462
UMLS CUI [1,6]
C0279492
UMLS CUI [1,7]
C3146298
UMLS CUI [1,8]
C0332300
UMLS CUI [1,9]
C1298675
UMLS CUI [1,10]
C1298676
UMLS CUI [2,1]
C2267073
UMLS CUI [2,2]
C2347852
UMLS CUI [3]
C0007347
subject has progressive disease by prostate-specific antigen (psa) or imaging.
Beschreibung

Progressive disease by prostate-specific antigen (psa) or imaging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1335499
UMLS CUI [1,2]
C0201544
UMLS CUI [2,1]
C1335499
UMLS CUI [2,2]
C0011923
subject has received no more than 2 prior chemotherapy regimens.
Beschreibung

Chemotherapy regimens quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1265611
subject has an eastern cooperative oncology group (ecog) performance status of 0-2.
Beschreibung

Eastern cooperative oncology group (ecog) performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
male subject must use a condom if having sex with a pregnant woman.
Beschreibung

Gender, use of condoms if having sex with a pregnant woman

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C1524063
UMLS CUI [1,3]
C0677582
UMLS CUI [1,4]
C0009253
UMLS CUI [1,5]
C0347984
UMLS CUI [1,6]
C0032961
male subject and their female spouse/partners who are of childbearing potential must use 2 acceptable methods of birth control starting at screening and continuing throughout the study period and for 3 months after final study drug administration.
Beschreibung

Use of 2 acceptable methods of birth control when there is a childbearing potential

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C1265611
subject has an estimated life expectancy of at least 6 months.
Beschreibung

Estimated life expectancy, minimum

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023671
UMLS CUI [1,2]
C0750572
UMLS CUI [1,3]
C1524031
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject has confirmed cyp2d6 poor metabolizer, or cyp2d6 ultrarapid metabolizer status based on genotyping analysis.
Beschreibung

CYP2D6 poor metaboliser status | CYP2D6 ultrarapid metaboliser status based on genotyping analysis.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3888904
UMLS CUI [1,2]
C0679560
UMLS CUI [2,1]
C3203681
UMLS CUI [2,2]
C0679560
subject has known metastases in the liver or any hepatic disorder that could affect drug metabolism deemed clinically significant by the investigator after discussion with the sponsor.
Beschreibung

Known metastases in the liver | Hepatic disorder that could affect drug metabolism

Datentyp

boolean

Alias
UMLS CUI [1]
C0494165
UMLS CUI [2,1]
C0023895
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0031328
subject has undergone major surgery within 4 weeks prior to day 1.
Beschreibung

Recent major surgery

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0679637
UMLS CUI [1,2]
C0332185
subject received treatment with chemotherapy within 4 weeks prior to enrollment (day 1 visit) or plans to initiate treatment with chemotherapy during the study.
Beschreibung

Recent chemotherapy | Chemotherapy planned during the study

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C1301732
UMLS CUI [2,2]
C0392920
UMLS CUI [2,3]
C0347984
UMLS CUI [2,4]
C0008976
subject uses concomitant medications that are potent inducers and/or inhibitors of cyp1a2, cyp2c8, cyp2d6, or cyp3a4.
Beschreibung

Inducers and/or inhibitors of cyp1a2, cyp2c8, cyp2d6, or cyp3a4.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C3850050
UMLS CUI [2,1]
C2347852
UMLS CUI [2,2]
C3850068
UMLS CUI [3,1]
C2347852
UMLS CUI [3,2]
C3850048
UMLS CUI [4,1]
C2347852
UMLS CUI [4,2]
C3850061
UMLS CUI [5,1]
C2347852
UMLS CUI [5,2]
C3850058
UMLS CUI [6,1]
C2347852
UMLS CUI [6,2]
C3850045
UMLS CUI [7,1]
C2347852
UMLS CUI [7,2]
C3830624
UMLS CUI [8,1]
C2347852
UMLS CUI [8,2]
C3830625
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Ähnliche Modelle

Eligibility Pharmacokinetics of Caffeine NCT02225093

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age, Histologically confirmed prostate cancer, indication of androgen deprivation therapy | Concomitant treatment with gonadotropin releasing hormone (gnrh) analogue possible | Status post bilateral orchiectomy
Item
subject is a male aged 18 years old or older (at screening) with histologically confirmed prostate cancer (all stages) for whom androgen deprivation therapy is indicated (except when indicated in a neoadjuvant/adjuvant setting). subjects may be on ongoing androgen deprivation therapy with a gonadotropin releasing hormone (gnrh) analogue or have undergone prior bilateral orchiectomy at screening.
boolean
C0001779 (UMLS CUI [1,1])
C0079399 (UMLS CUI [1,2])
C0600139 (UMLS CUI [1,3])
C0521093 (UMLS CUI [1,4])
C0205462 (UMLS CUI [1,5])
C0279492 (UMLS CUI [1,6])
C3146298 (UMLS CUI [1,7])
C0332300 (UMLS CUI [1,8])
C1298675 (UMLS CUI [1,9])
C1298676 (UMLS CUI [1,10])
C2267073 (UMLS CUI [2,1])
C2347852 (UMLS CUI [2,2])
C0007347 (UMLS CUI [3])
Progressive disease by prostate-specific antigen (psa) or imaging
Item
subject has progressive disease by prostate-specific antigen (psa) or imaging.
boolean
C1335499 (UMLS CUI [1,1])
C0201544 (UMLS CUI [1,2])
C1335499 (UMLS CUI [2,1])
C0011923 (UMLS CUI [2,2])
Chemotherapy regimens quantity
Item
subject has received no more than 2 prior chemotherapy regimens.
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Eastern cooperative oncology group (ecog) performance status
Item
subject has an eastern cooperative oncology group (ecog) performance status of 0-2.
boolean
C1520224 (UMLS CUI [1])
Gender, use of condoms if having sex with a pregnant woman
Item
male subject must use a condom if having sex with a pregnant woman.
boolean
C0079399 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
C0677582 (UMLS CUI [1,3])
C0009253 (UMLS CUI [1,4])
C0347984 (UMLS CUI [1,5])
C0032961 (UMLS CUI [1,6])
Use of 2 acceptable methods of birth control when there is a childbearing potential
Item
male subject and their female spouse/partners who are of childbearing potential must use 2 acceptable methods of birth control starting at screening and continuing throughout the study period and for 3 months after final study drug administration.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Estimated life expectancy, minimum
Item
subject has an estimated life expectancy of at least 6 months.
boolean
C0023671 (UMLS CUI [1,1])
C0750572 (UMLS CUI [1,2])
C1524031 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
CYP2D6 poor metaboliser status | CYP2D6 ultrarapid metaboliser status based on genotyping analysis.
Item
subject has confirmed cyp2d6 poor metabolizer, or cyp2d6 ultrarapid metabolizer status based on genotyping analysis.
boolean
C3888904 (UMLS CUI [1,1])
C0679560 (UMLS CUI [1,2])
C3203681 (UMLS CUI [2,1])
C0679560 (UMLS CUI [2,2])
Known metastases in the liver | Hepatic disorder that could affect drug metabolism
Item
subject has known metastases in the liver or any hepatic disorder that could affect drug metabolism deemed clinically significant by the investigator after discussion with the sponsor.
boolean
C0494165 (UMLS CUI [1])
C0023895 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0031328 (UMLS CUI [2,3])
Recent major surgery
Item
subject has undergone major surgery within 4 weeks prior to day 1.
boolean
C0679637 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Recent chemotherapy | Chemotherapy planned during the study
Item
subject received treatment with chemotherapy within 4 weeks prior to enrollment (day 1 visit) or plans to initiate treatment with chemotherapy during the study.
boolean
C0392920 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C1301732 (UMLS CUI [2,1])
C0392920 (UMLS CUI [2,2])
C0347984 (UMLS CUI [2,3])
C0008976 (UMLS CUI [2,4])
Inducers and/or inhibitors of cyp1a2, cyp2c8, cyp2d6, or cyp3a4.
Item
subject uses concomitant medications that are potent inducers and/or inhibitors of cyp1a2, cyp2c8, cyp2d6, or cyp3a4.
boolean
C2347852 (UMLS CUI [1,1])
C3850050 (UMLS CUI [1,2])
C2347852 (UMLS CUI [2,1])
C3850068 (UMLS CUI [2,2])
C2347852 (UMLS CUI [3,1])
C3850048 (UMLS CUI [3,2])
C2347852 (UMLS CUI [4,1])
C3850061 (UMLS CUI [4,2])
C2347852 (UMLS CUI [5,1])
C3850058 (UMLS CUI [5,2])
C2347852 (UMLS CUI [6,1])
C3850045 (UMLS CUI [6,2])
C2347852 (UMLS CUI [7,1])
C3830624 (UMLS CUI [7,2])
C2347852 (UMLS CUI [8,1])
C3830625 (UMLS CUI [8,2])
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