ID

13770

Description

Cytochrom p450 3A4 and 1A2 Phenotyping for the Individualization of Treatment With Sunitinib or Erlotinib in Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01402089

Link

https://clinicaltrials.gov/show/NCT01402089

Keywords

Versions (1)
  1. 3/6/16 3/6/16 -
Uploaded on

March 6, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Non Small-cell Lung Cancer NCT01402089

English

Eligibility Non Small-cell Lung Cancer NCT01402089

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed renal-cell cancer or gastrointestinal stromal tumor (for sunitinib) or non small-cell lung cancer (for erlotinib)
Description

renal-cell cancer; gastrointestinal stromal tumor; non small-cell lung cancer; sunitinib; erlotinib

Data type

boolean

Alias
UMLS CUI [1]
C0007134
UMLS CUI [2]
C0238198
UMLS CUI [3]
C0007131
UMLS CUI [4]
C1176020
UMLS CUI [5]
C1135135
both early or advanced tumor stage
Description

tumor stage

Data type

boolean

Alias
UMLS CUI [1]
C1300072
indication for the therapeutic use of either sunitinib or erlotinib
Description

sunitinib; erlotinib

Data type

boolean

Alias
UMLS CUI [1]
C1176020
UMLS CUI [2]
C1135135
written informed consent and willing to undergo pk-sampling
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
patients > 18 years of age
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance status or ≤2
Description

ecog

Data type

boolean

Alias
UMLS CUI [1]
C1520224
adequate laboratory parameters:
Description

laboratory parameters

Data type

boolean

Alias
UMLS CUI [1]
C0022885
i. serum creatinine and serum bilirubin ≤ 1.5 x uln ii. serum alt and ast ≤ 2.5 x uln (or ≤ 5 in case of liver metastases) iii. serum calcium ≤ 11,6 mg/dl (2.9 mmol/l)
Description

serum creatinine; serum bilirubin; alt and ast; serum calcium

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0428441
UMLS CUI [3]
C3831581
UMLS CUI [4]
C0728876
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous treatment with sunitinib or erlotinib
Description

sunitinib; erlotinib

Data type

boolean

Alias
UMLS CUI [1]
C1176020
UMLS CUI [2]
C1135135
known hypersensitivity to trial drug or any compounds of the drug
Description

hypersensitivity study drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0008972
concurrent radiotherapy
Description

concurrent therapy radiotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0009429
UMLS CUI [1,2]
C1522449
concurrent systemic anticancer treatment with the exception of bisphosphonates and bevacizumab in patients with non small-cell lung cancer
Description

concurrent therapy cancer treatment; bisphosphonates; bevacizumab

Data type

boolean

Alias
UMLS CUI [1,1]
C0009429
UMLS CUI [1,2]
C0920425
UMLS CUI [2]
C0012544
UMLS CUI [3]
C0796392
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Similar models

Eligibility Non Small-cell Lung Cancer NCT01402089

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
renal-cell cancer; gastrointestinal stromal tumor; non small-cell lung cancer; sunitinib; erlotinib
Item
histologically or cytologically confirmed renal-cell cancer or gastrointestinal stromal tumor (for sunitinib) or non small-cell lung cancer (for erlotinib)
boolean
C0007134 (UMLS CUI [1])
C0238198 (UMLS CUI [2])
C0007131 (UMLS CUI [3])
C1176020 (UMLS CUI [4])
C1135135 (UMLS CUI [5])
tumor stage
Item
both early or advanced tumor stage
boolean
C1300072 (UMLS CUI [1])
sunitinib; erlotinib
Item
indication for the therapeutic use of either sunitinib or erlotinib
boolean
C1176020 (UMLS CUI [1])
C1135135 (UMLS CUI [2])
informed consent
Item
written informed consent and willing to undergo pk-sampling
boolean
C0021430 (UMLS CUI [1])
age
Item
patients > 18 years of age
boolean
C0001779 (UMLS CUI [1])
ecog
Item
ecog performance status or ≤2
boolean
C1520224 (UMLS CUI [1])
laboratory parameters
Item
adequate laboratory parameters:
boolean
C0022885 (UMLS CUI [1])
serum creatinine; serum bilirubin; alt and ast; serum calcium
Item
i. serum creatinine and serum bilirubin ≤ 1.5 x uln ii. serum alt and ast ≤ 2.5 x uln (or ≤ 5 in case of liver metastases) iii. serum calcium ≤ 11,6 mg/dl (2.9 mmol/l)
boolean
C0201976 (UMLS CUI [1])
C0428441 (UMLS CUI [2])
C3831581 (UMLS CUI [3])
C0728876 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
sunitinib; erlotinib
Item
previous treatment with sunitinib or erlotinib
boolean
C1176020 (UMLS CUI [1])
C1135135 (UMLS CUI [2])
hypersensitivity study drugs
Item
known hypersensitivity to trial drug or any compounds of the drug
boolean
C0020517 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0008972 (UMLS CUI [1,3])
concurrent therapy radiotherapy
Item
concurrent radiotherapy
boolean
C0009429 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
concurrent therapy cancer treatment; bisphosphonates; bevacizumab
Item
concurrent systemic anticancer treatment with the exception of bisphosphonates and bevacizumab in patients with non small-cell lung cancer
boolean
C0009429 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
C0012544 (UMLS CUI [2])
C0796392 (UMLS CUI [3])
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