ID

38385

Beschreibung

Trial of Dasatinib in Subjects With Advanced Cancers Harboring DDR2 Mutation or Inactivating B-RAF Mutation; ODM derived from: https://clinicaltrials.gov/show/NCT01514864

Link

https://clinicaltrials.gov/show/NCT01514864

Stichworte

Versionen (1)
  1. 15.10.19 15.10.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

15. Oktober 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Carcinoma, Non-small Cell Lung NCT01514864

Englisch

Eligibility Carcinoma, Non-small Cell Lung NCT01514864

1 Formulare  
Criteria
Beschreibung

Criteria

Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of advanced malignancy, non-small cell lung cancer (nsclc) only during stage 1 of accrual
Beschreibung

Non-Small Cell Lung Carcinoma Advanced

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0205179
non-synonymous mutation of b-raf or ddr2, defined as follows:
Beschreibung

Missense Mutation BRAF gene | Missense Mutation DDR2 gene

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0599155
UMLS CUI [1,2]
C0812241
UMLS CUI [2,1]
C0599155
UMLS CUI [2,2]
C1333207
nsclc with inactivating b-raf mutation
Beschreibung

Non-Small Cell Lung Carcinoma | Inactivation BRAF gene mutation

Datentyp

boolean

Alias
UMLS CUI [1]
C0007131
UMLS CUI [2,1]
C0598496
UMLS CUI [2,2]
C1511021
nsclc with ddr2 mutation
Beschreibung

Non-Small Cell Lung Carcinoma | DDR2 gene Mutation

Datentyp

boolean

Alias
UMLS CUI [1]
C0007131
UMLS CUI [2,1]
C1333207
UMLS CUI [2,2]
C0596611
malignancy of other histology with ddr2 mutation or inactivating b-raf mutation, or nsclc having a b-raf mutation which is not functionally characterized
Beschreibung

Cancer Other | DDR2 gene Mutation | Inactivation BRAF gene mutation

Datentyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1333207
UMLS CUI [2,2]
C0596611
UMLS CUI [3,1]
C0598496
UMLS CUI [3,2]
C1511021
at least one target lesion per response evaluation criteria in solid tumors (recist) 1.1 criteria on baseline staging evaluation
Beschreibung

Target Lesion Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C1265611
disease progression after ≥ 1 prior treatment regimen
Beschreibung

Disease Progression | Status post Prior Therapy Quantity

Datentyp

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C1514463
UMLS CUI [2,3]
C1265611
exception: subjects with nsclc of squamous type and ddr2 mutation may be enrolled in first line, no prior treatment is required
Beschreibung

Exception First line treatment Squamous non-small cell lung cancer | Exception First line treatment DDR2 gene Mutation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1705847
UMLS CUI [1,2]
C1708063
UMLS CUI [1,3]
C4509816
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1708063
UMLS CUI [2,3]
C1333207
UMLS CUI [2,4]
C0596611
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
pleural or pericardial effusion grade > 1
Beschreibung

Pleural effusion CTCAE Grades | Pericardial effusion CTCAE Grades

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032227
UMLS CUI [1,2]
C1516728
UMLS CUI [2,1]
C0031039
UMLS CUI [2,2]
C1516728
qtcf > 470 msec (grade ≥ 2) or diagnosed congenital long qt syndrome
Beschreibung

QTcF Prolongation | Congenital long QT syndrome

Datentyp

boolean

Alias
UMLS CUI [1]
C3828431
UMLS CUI [2]
C1141890
absolute granulocyte count < 1,500/mm3
Beschreibung

Absolute neutrophil count

Datentyp

boolean

Alias
UMLS CUI [1]
C0948762
hemoglobin < 10 g/dl
Beschreibung

Hemoglobin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0518015
platelet count < 75,000/mm3
Beschreibung

Platelet Count measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0032181
serum calcium < institutional lower limit of normal (lln)
Beschreibung

Serum calcium decreased

Datentyp

boolean

Alias
UMLS CUI [1]
C0595882
hypokalemia, hypophosphatemia or hypomagnesemia grade > 1, despite supplementation
Beschreibung

Hypokalemia Grade | Hypophosphatemia Grade | Hypomagnesemia Grade | Supplementation Inefficient

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020621
UMLS CUI [1,2]
C0441800
UMLS CUI [2,1]
C0085682
UMLS CUI [2,2]
C0441800
UMLS CUI [3,1]
C0151723
UMLS CUI [3,2]
C0441800
UMLS CUI [4,1]
C0242297
UMLS CUI [4,2]
C0231185
creatinine > 3 x institutional upper limit of normal (uln)
Beschreibung

Serum creatinine raised

Datentyp

boolean

Alias
UMLS CUI [1]
C0700225
total bilirubin > 1.5 x uln
Beschreibung

Elevated total bilirubin

Datentyp

boolean

Alias
UMLS CUI [1]
C0741494
alanine transaminase (alt) > 3 x uln
Beschreibung

Alanine aminotransferase increased

Datentyp

boolean

Alias
UMLS CUI [1]
C0151905
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Ähnliche Modelle

Eligibility Carcinoma, Non-small Cell Lung NCT01514864

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma Advanced
Item
diagnosis of advanced malignancy, non-small cell lung cancer (nsclc) only during stage 1 of accrual
boolean
C0007131 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
Missense Mutation BRAF gene | Missense Mutation DDR2 gene
Item
non-synonymous mutation of b-raf or ddr2, defined as follows:
boolean
C0599155 (UMLS CUI [1,1])
C0812241 (UMLS CUI [1,2])
C0599155 (UMLS CUI [2,1])
C1333207 (UMLS CUI [2,2])
Non-Small Cell Lung Carcinoma | Inactivation BRAF gene mutation
Item
nsclc with inactivating b-raf mutation
boolean
C0007131 (UMLS CUI [1])
C0598496 (UMLS CUI [2,1])
C1511021 (UMLS CUI [2,2])
Non-Small Cell Lung Carcinoma | DDR2 gene Mutation
Item
nsclc with ddr2 mutation
boolean
C0007131 (UMLS CUI [1])
C1333207 (UMLS CUI [2,1])
C0596611 (UMLS CUI [2,2])
Cancer Other | DDR2 gene Mutation | Inactivation BRAF gene mutation
Item
malignancy of other histology with ddr2 mutation or inactivating b-raf mutation, or nsclc having a b-raf mutation which is not functionally characterized
boolean
C1707251 (UMLS CUI [1])
C1333207 (UMLS CUI [2,1])
C0596611 (UMLS CUI [2,2])
C0598496 (UMLS CUI [3,1])
C1511021 (UMLS CUI [3,2])
Target Lesion Quantity
Item
at least one target lesion per response evaluation criteria in solid tumors (recist) 1.1 criteria on baseline staging evaluation
boolean
C2986546 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Disease Progression | Status post Prior Therapy Quantity
Item
disease progression after ≥ 1 prior treatment regimen
boolean
C0242656 (UMLS CUI [1])
C0231290 (UMLS CUI [2,1])
C1514463 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Exception First line treatment Squamous non-small cell lung cancer | Exception First line treatment DDR2 gene Mutation
Item
exception: subjects with nsclc of squamous type and ddr2 mutation may be enrolled in first line, no prior treatment is required
boolean
C1705847 (UMLS CUI [1,1])
C1708063 (UMLS CUI [1,2])
C4509816 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C1708063 (UMLS CUI [2,2])
C1333207 (UMLS CUI [2,3])
C0596611 (UMLS CUI [2,4])
Item Group
C0680251 (UMLS CUI)
Pleural effusion CTCAE Grades | Pericardial effusion CTCAE Grades
Item
pleural or pericardial effusion grade > 1
boolean
C0032227 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C0031039 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
QTcF Prolongation | Congenital long QT syndrome
Item
qtcf > 470 msec (grade ≥ 2) or diagnosed congenital long qt syndrome
boolean
C3828431 (UMLS CUI [1])
C1141890 (UMLS CUI [2])
Absolute neutrophil count
Item
absolute granulocyte count < 1,500/mm3
boolean
C0948762 (UMLS CUI [1])
Hemoglobin measurement
Item
hemoglobin < 10 g/dl
boolean
C0518015 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count < 75,000/mm3
boolean
C0032181 (UMLS CUI [1])
Serum calcium decreased
Item
serum calcium < institutional lower limit of normal (lln)
boolean
C0595882 (UMLS CUI [1])
Hypokalemia Grade | Hypophosphatemia Grade | Hypomagnesemia Grade | Supplementation Inefficient
Item
hypokalemia, hypophosphatemia or hypomagnesemia grade > 1, despite supplementation
boolean
C0020621 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0085682 (UMLS CUI [2,1])
C0441800 (UMLS CUI [2,2])
C0151723 (UMLS CUI [3,1])
C0441800 (UMLS CUI [3,2])
C0242297 (UMLS CUI [4,1])
C0231185 (UMLS CUI [4,2])
Serum creatinine raised
Item
creatinine > 3 x institutional upper limit of normal (uln)
boolean
C0700225 (UMLS CUI [1])
Elevated total bilirubin
Item
total bilirubin > 1.5 x uln
boolean
C0741494 (UMLS CUI [1])
Alanine aminotransferase increased
Item
alanine transaminase (alt) > 3 x uln
boolean
C0151905 (UMLS CUI [1])
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