ID

18881

Description

Phase I study of panobinostat and imatinib in patients with treatment-refractory metastatic gastrointestinal stromal tumors WTZ-GIST-09-01 (EudraCT number: 2009-011417-24; German Clinical Trials Register: DRKS00000657) was approved by the institutional ethics committees of the two participating centers and the German Federal Regulatory Drug Agency (BfArM; 4035954).

Keywords

Versions (2)
  1. 11/20/16 11/20/16 -
  2. 11/23/16 11/23/16 -
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November 23, 2016

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Creative Commons BY-NC-ND 3.0
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WTZ-GIST-09-01 (Imatinib + LBH589) Cycle 1 Pharmacokinetics 2009-011417-24 DRKS00000657

English

WTZ-GIST-09-01 (Imatinib + LBH589) Cycle 1 Pharmacokinetics 2009-011417-24

1 forms  
Pharmacokinetics (PK)
Description

Pharmacokinetics (PK)

Alias
UMLS CUI-1
C0031327
Time of administration (LBH)
Description

Time of administration (LBH)

Data type

time

Measurement units
  • HH:NN
Alias
UMLS CUI [1,1]
C1317775
UMLS CUI [1,2]
C1566164
HH:NN
Time of administration (Imatinib)
Description

Time of administration (Imatinib)

Data type

time

Measurement units
  • HH:NN
Alias
UMLS CUI [1,1]
C1317775
UMLS CUI [1,2]
C0935989
HH:NN
Date
Description

Date of administration

Data type

date

Measurement units
  • YYYY-MM-DD
Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0011008
YYYY-MM-DD
PK sample taken (0h prior to therapy, 0,5h (+- 5') after therapy, 1h after therapy, 2h after therapy, 4h after therapy, 8h after therapy, 24h after therapy)
Description

Pharmacokinetics sample taken

Data type

boolean

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0031327
Time PK sample taken (0h prior to therapy, 0,5h (+- 5') after therapy, 1h after therapy, 2h after therapy, 4h after therapy, 8h after therapy, 24h after therapy)
Description

Time Pharmacokinetics sample taken

Data type

time

Measurement units
  • HH:NN
Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0031327
UMLS CUI [2]
C0040223
HH:NN
End Date
Description

End Date

Data type

date

Measurement units
  • YYYY-MM-DD
Alias
UMLS CUI [1]
C0806020
YYYY-MM-DD
If PK sample was not taken please comment
Description

Comment

Data type

text

Alias
UMLS CUI [1]
C0947611
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Similar models

WTZ-GIST-09-01 (Imatinib + LBH589) Cycle 1 Pharmacokinetics 2009-011417-24

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Pharmacokinetics (PK)
C0031327 (UMLS CUI-1)
Time of administration (LBH)
Item
Time of administration (LBH)
time
C1317775 (UMLS CUI [1,1])
C1566164 (UMLS CUI [1,2])
Time of administration (Imatinib)
Item
Time of administration (Imatinib)
time
C1317775 (UMLS CUI [1,1])
C0935989 (UMLS CUI [1,2])
Date of administration
Item
Date
date
C1533734 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Pharmacokinetics sample taken
Item
PK sample taken (0h prior to therapy, 0,5h (+- 5') after therapy, 1h after therapy, 2h after therapy, 4h after therapy, 8h after therapy, 24h after therapy)
boolean
C1277698 (UMLS CUI [1,1])
C0031327 (UMLS CUI [1,2])
Time Pharmacokinetics sample taken
Item
Time PK sample taken (0h prior to therapy, 0,5h (+- 5') after therapy, 1h after therapy, 2h after therapy, 4h after therapy, 8h after therapy, 24h after therapy)
time
C1277698 (UMLS CUI [1,1])
C0031327 (UMLS CUI [1,2])
C0040223 (UMLS CUI [2])
End Date
Item
End Date
date
C0806020 (UMLS CUI [1])
Comment
Item
If PK sample was not taken please comment
text
C0947611 (UMLS CUI [1])
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