ID

42363

Beskrivning

Study of the Combination of ACP-196 and Pembrolizumab in Subjects With Advanced Head and Neck Squamous Cell Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT02454179

Länk

https://clinicaltrials.gov/show/NCT02454179

Nyckelord

Versioner (2)
  1. 2021-06-23 2021-06-23 -
  2. 2021-06-30 2021-06-30 -
Rättsinnehavare

Acerta Pharma BV

Uppladdad den

23 juni 2021

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Squamous Cell Carcinoma of the Head and Neck NCT02454179

Engelsk

Eligibility Squamous Cell Carcinoma of the Head and Neck NCT02454179

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
men and women ≥ 18 years of age
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
histologically or cytologically confirmed recurrent, metastatic or unresectable hnscc of the oral cavity, oropharynx, hypopharynx, and larynx that that has either progressed during or after platinum-based chemotherapy administered for metastatic disease or has recurred during or within 6 months after the completion of platinum-based neoadjuvant or adjuvant therapy
Beskrivning

Histologically or cytologically confirmed hnscc of the oral cavity, oropharynx, hypopharynx, or larynx | recurrent, metastatic or unresectable hnscc | progressed despite platinum-based chemotherapy | recently recurrent despite platinum-based (neo)adjuvant chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0585362
UMLS CUI [1,2]
C0205462
UMLS CUI [2,1]
C0280313
UMLS CUI [2,2]
C0205462
UMLS CUI [3,1]
C0280321
UMLS CUI [3,2]
C0205462
UMLS CUI [4,1]
C0280324
UMLS CUI [4,2]
C0205462
UMLS CUI [5,1]
C0585362
UMLS CUI [5,2]
C0205471
UMLS CUI [6,1]
C0280313
UMLS CUI [6,2]
C0205471
UMLS CUI [7,1]
C0280321
UMLS CUI [7,2]
C0205471
UMLS CUI [8,1]
C0280324
UMLS CUI [8,2]
C0205471
UMLS CUI [9,1]
C1168401
UMLS CUI [9,2]
C2945760
UMLS CUI [10,1]
C1168401
UMLS CUI [10,2]
C0027627
UMLS CUI [11,1]
C1168401
UMLS CUI [11,2]
C1519810
UMLS CUI [12,1]
C0242656
UMLS CUI [12,2]
C3641650
UMLS CUI [12,3]
C0392920
UMLS CUI [12,4]
C1514162
UMLS CUI [13,1]
C0277556
UMLS CUI [13,2]
C0332185
UMLS CUI [13,3]
C3641650
UMLS CUI [13,4]
C0543467
UMLS CUI [13,5]
C0392920
UMLS CUI [13,6]
C1514162
presence of radiographically measurable disease as defined by recist 1.1
Beskrivning

Radiographically measurable disease, RECIST

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0034571
UMLS CUI [1,3]
C1709926
ecog performance status of 0 or 1
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior malignancy (other than hnscc), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for ≥ 2 years or which will not limit survival to < 2 years
Beskrivning

Malignant Neoplasm except for hnscc | adequately treated basal cell carcinoma | adequately treated squamous cell skin cancer | in situ cervical cancer | other previous malign neoplasms disease free | other previous malign neoplasms life expectancy limited

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0332300
UMLS CUI [2,2]
C1168401
UMLS CUI [3,1]
C0332300
UMLS CUI [3,2]
C0007117
UMLS CUI [3,3]
C0087111
UMLS CUI [3,4]
C0205411
UMLS CUI [4,1]
C0332300
UMLS CUI [4,2]
C0553723
UMLS CUI [4,3]
C0087111
UMLS CUI [4,4]
C0205411
UMLS CUI [5,1]
C0332300
UMLS CUI [5,2]
C0851140
UMLS CUI [6,1]
C0332300
UMLS CUI [6,2]
C0006826
UMLS CUI [6,3]
C0205156
UMLS CUI [6,4]
C0205394
UMLS CUI [6,5]
C0242793
UMLS CUI [7,1]
C0332300
UMLS CUI [7,2]
C0006826
UMLS CUI [7,3]
C0205156
UMLS CUI [7,4]
C0205394
UMLS CUI [7,5]
C0023671
UMLS CUI [7,6]
C0439801
known central nervous system metastases and/or carcinomatous meningitis
Beskrivning

CNS metastases | carcinomatous meningitis

Datatyp

boolean

Alias
UMLS CUI [1]
C0686377
UMLS CUI [2]
C0220654
a life-threatening illness, medical condition (including psychiatric conditions) or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety
Beskrivning

Disease life-threatening | medical condition | mental disorder | organ system dysfunction | compromise patient safety judgement clinical investigator

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2826244
UMLS CUI [1,3]
C2945640
UMLS CUI [1,4]
C1113679
UMLS CUI [1,5]
C0022423
UMLS CUI [1,6]
C0008961
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C2945640
UMLS CUI [2,3]
C1113679
UMLS CUI [2,4]
C0022423
UMLS CUI [2,5]
C0008961
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C2945640
UMLS CUI [3,3]
C1113679
UMLS CUI [3,4]
C0022423
UMLS CUI [3,5]
C0008961
UMLS CUI [4,1]
C0460002
UMLS CUI [4,2]
C3887504
UMLS CUI [4,3]
C2945640
UMLS CUI [4,4]
C1113679
UMLS CUI [4,5]
C0022423
UMLS CUI [4,6]
C0008961
significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of starting study drug
Beskrivning

Cardiovascular diseases clinical significance | uncontrolled or symptomatic arrhythmias | congestive heart failure | myocardial infarction

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C2826293
UMLS CUI [2,1]
C0003811
UMLS CUI [2,2]
C0205318
UMLS CUI [3,1]
C0003811
UMLS CUI [3,2]
C0231220
UMLS CUI [4]
C0018802
UMLS CUI [5]
C0027051
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Similar models

Eligibility Squamous Cell Carcinoma of the Head and Neck NCT02454179

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
men and women ≥ 18 years of age
boolean
C0001779 (UMLS CUI [1])
Histologically or cytologically confirmed hnscc of the oral cavity, oropharynx, hypopharynx, or larynx | recurrent, metastatic or unresectable hnscc | progressed despite platinum-based chemotherapy | recently recurrent despite platinum-based (neo)adjuvant chemotherapy
Item
histologically or cytologically confirmed recurrent, metastatic or unresectable hnscc of the oral cavity, oropharynx, hypopharynx, and larynx that that has either progressed during or after platinum-based chemotherapy administered for metastatic disease or has recurred during or within 6 months after the completion of platinum-based neoadjuvant or adjuvant therapy
boolean
C0585362 (UMLS CUI [1,1])
C0205462 (UMLS CUI [1,2])
C0280313 (UMLS CUI [2,1])
C0205462 (UMLS CUI [2,2])
C0280321 (UMLS CUI [3,1])
C0205462 (UMLS CUI [3,2])
C0280324 (UMLS CUI [4,1])
C0205462 (UMLS CUI [4,2])
C0585362 (UMLS CUI [5,1])
C0205471 (UMLS CUI [5,2])
C0280313 (UMLS CUI [6,1])
C0205471 (UMLS CUI [6,2])
C0280321 (UMLS CUI [7,1])
C0205471 (UMLS CUI [7,2])
C0280324 (UMLS CUI [8,1])
C0205471 (UMLS CUI [8,2])
C1168401 (UMLS CUI [9,1])
C2945760 (UMLS CUI [9,2])
C1168401 (UMLS CUI [10,1])
C0027627 (UMLS CUI [10,2])
C1168401 (UMLS CUI [11,1])
C1519810 (UMLS CUI [11,2])
C0242656 (UMLS CUI [12,1])
C3641650 (UMLS CUI [12,2])
C0392920 (UMLS CUI [12,3])
C1514162 (UMLS CUI [12,4])
C0277556 (UMLS CUI [13,1])
C0332185 (UMLS CUI [13,2])
C3641650 (UMLS CUI [13,3])
C0543467 (UMLS CUI [13,4])
C0392920 (UMLS CUI [13,5])
C1514162 (UMLS CUI [13,6])
Radiographically measurable disease, RECIST
Item
presence of radiographically measurable disease as defined by recist 1.1
boolean
C1513041 (UMLS CUI [1,1])
C0034571 (UMLS CUI [1,2])
C1709926 (UMLS CUI [1,3])
ECOG performance status
Item
ecog performance status of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Malignant Neoplasm except for hnscc | adequately treated basal cell carcinoma | adequately treated squamous cell skin cancer | in situ cervical cancer | other previous malign neoplasms disease free | other previous malign neoplasms life expectancy limited
Item
prior malignancy (other than hnscc), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for ≥ 2 years or which will not limit survival to < 2 years
boolean
C0006826 (UMLS CUI [1])
C0332300 (UMLS CUI [2,1])
C1168401 (UMLS CUI [2,2])
C0332300 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C0087111 (UMLS CUI [3,3])
C0205411 (UMLS CUI [3,4])
C0332300 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
C0087111 (UMLS CUI [4,3])
C0205411 (UMLS CUI [4,4])
C0332300 (UMLS CUI [5,1])
C0851140 (UMLS CUI [5,2])
C0332300 (UMLS CUI [6,1])
C0006826 (UMLS CUI [6,2])
C0205156 (UMLS CUI [6,3])
C0205394 (UMLS CUI [6,4])
C0242793 (UMLS CUI [6,5])
C0332300 (UMLS CUI [7,1])
C0006826 (UMLS CUI [7,2])
C0205156 (UMLS CUI [7,3])
C0205394 (UMLS CUI [7,4])
C0023671 (UMLS CUI [7,5])
C0439801 (UMLS CUI [7,6])
CNS metastases | carcinomatous meningitis
Item
known central nervous system metastases and/or carcinomatous meningitis
boolean
C0686377 (UMLS CUI [1])
C0220654 (UMLS CUI [2])
Disease life-threatening | medical condition | mental disorder | organ system dysfunction | compromise patient safety judgement clinical investigator
Item
a life-threatening illness, medical condition (including psychiatric conditions) or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety
boolean
C0012634 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
C2945640 (UMLS CUI [1,3])
C1113679 (UMLS CUI [1,4])
C0022423 (UMLS CUI [1,5])
C0008961 (UMLS CUI [1,6])
C0012634 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])
C0022423 (UMLS CUI [2,4])
C0008961 (UMLS CUI [2,5])
C0004936 (UMLS CUI [3,1])
C2945640 (UMLS CUI [3,2])
C1113679 (UMLS CUI [3,3])
C0022423 (UMLS CUI [3,4])
C0008961 (UMLS CUI [3,5])
C0460002 (UMLS CUI [4,1])
C3887504 (UMLS CUI [4,2])
C2945640 (UMLS CUI [4,3])
C1113679 (UMLS CUI [4,4])
C0022423 (UMLS CUI [4,5])
C0008961 (UMLS CUI [4,6])
Cardiovascular diseases clinical significance | uncontrolled or symptomatic arrhythmias | congestive heart failure | myocardial infarction
Item
significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of starting study drug
boolean
C0007222 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0003811 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0003811 (UMLS CUI [3,1])
C0231220 (UMLS CUI [3,2])
C0018802 (UMLS CUI [4])
C0027051 (UMLS CUI [5])
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