ID

38450

Description

Sym004 in Subjects With Squamous Cell Carcinoma of Head and Neck (SCCHN) Failing Anti-Epidermal Growth Factor Receptor (Anti-EGFR) Based Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT01417936

Link

https://clinicaltrials.gov/show/NCT01417936

Keywords

Versions (1)
  1. 10/18/19 10/18/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 18, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Carcinoma, Squamous Cell of Head and Neck NCT01417936

English

Eligibility Carcinoma, Squamous Cell of Head and Neck NCT01417936

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed diagnosis initially or at relapse of scchn of the oral cavity, oropharynx, hypopharynx or larynx
Description

Squamous cell carcinoma of the head and neck Initially | Recurrent Head and Neck Squamous Cell Carcinoma | Squamous cell carcinoma of mouth | Squamous cell carcinoma of oropharynx | Squamous cell carcinoma of the hypopharynx | Laryngeal Squamous Cell Carcinoma | Squamous cell carcinoma of the oral cavity recurrent | Oropharyngeal squamous cell carcinoma recurrent | Squamous cell carcinoma of the hypopharynx recurrent | Laryngeal squamous cell carcinoma recurrent

Data type

boolean

Alias
UMLS CUI [1,1]
C1168401
UMLS CUI [1,2]
C0205265
UMLS CUI [2]
C4524839
UMLS CUI [3]
C0585362
UMLS CUI [4]
C0280313
UMLS CUI [5]
C0280321
UMLS CUI [6]
C0280324
UMLS CUI [7]
C0861556
UMLS CUI [8]
C0280376
UMLS CUI [9]
C0280392
UMLS CUI [10]
C0280401
recurrent and/or metastatic scchn not amenable to curative treatment with surgery and/or (chemo)radiation
Description

Recurrent Head and Neck Squamous Cell Carcinoma Inappropriate Curative Surgery | HEAD NECK CANCER SQUAMOUS CELL METASTATIC Inappropriate Curative Surgery | Recurrent Head and Neck Squamous Cell Carcinoma Inappropriate Therapeutic radiology procedure Curative | HEAD NECK CANCER SQUAMOUS CELL METASTATIC Inappropriate Therapeutic radiology procedure Curative | Recurrent Head and Neck Squamous Cell Carcinoma Inappropriate Chemoradiotherapy Curative | HEAD NECK CANCER SQUAMOUS CELL METASTATIC Inappropriate Chemoradiotherapy Curative

Data type

boolean

Alias
UMLS CUI [1,1]
C4524839
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C1511562
UMLS CUI [2,1]
C0744620
UMLS CUI [2,2]
C1548788
UMLS CUI [2,3]
C1511562
UMLS CUI [3,1]
C4524839
UMLS CUI [3,2]
C1548788
UMLS CUI [3,3]
C1522449
UMLS CUI [3,4]
C1276305
UMLS CUI [4,1]
C0744620
UMLS CUI [4,2]
C1548788
UMLS CUI [4,3]
C1522449
UMLS CUI [4,4]
C1276305
UMLS CUI [5,1]
C4524839
UMLS CUI [5,2]
C1548788
UMLS CUI [5,3]
C0436307
UMLS CUI [5,4]
C1276305
UMLS CUI [6,1]
C0744620
UMLS CUI [6,2]
C1548788
UMLS CUI [6,3]
C0436307
UMLS CUI [6,4]
C1276305
previous treatment with an anti-egfr monoclonal antibody (mab) in the palliative setting either as monotherapy or in combination with chemotherapy or radiotherapy and showing:
Description

Anti-egfr monoclonal antibody therapy Palliative | Combined Modality Therapy | Chemotherapy | Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C4316122
UMLS CUI [1,2]
C1285530
UMLS CUI [2]
C0009429
UMLS CUI [3]
C0392920
UMLS CUI [4]
C1522449
documented clinical benefit or response for at least 8 weeks (pr, cr or sd) on the anti-egfr mab-based therapy and
Description

Benefit Clinical Anti-egfr monoclonal antibody therapy | Response Anti-egfr monoclonal antibody therapy | Partial response | In complete remission | Stable Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0814225
UMLS CUI [1,2]
C0205210
UMLS CUI [1,3]
C4316122
UMLS CUI [2,1]
C1704632
UMLS CUI [2,2]
C4316122
UMLS CUI [3]
C1521726
UMLS CUI [4]
C0677874
UMLS CUI [5]
C0677946
documented disease progression (verified by computed tomography [ct] scan or magnetic resonance imaging [mri] according to recist (1.1) during or within 12 weeks following the last administration of anti-egfr mab
Description

Disease Progression CT scan | Disease Progression MRI | Status post Anti-egfr monoclonal antibody therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0242656
UMLS CUI [1,2]
C0040405
UMLS CUI [2,1]
C0242656
UMLS CUI [2,2]
C0024485
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C4316122
accessible tumor for biopsy and subject acceptance of repeat tumor biopsies
Description

Neoplasm Amenable Biopsy | Neoplasm Biopsy Repeated

Data type

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C3900053
UMLS CUI [1,3]
C0005558
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C0005558
UMLS CUI [2,3]
C0205341
other protocol-defined inclusion criteria could apply
Description

Inclusion criteria Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C2348563
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
more than 2 lines of prior chemotherapy in the palliative setting
Description

Prior Chemotherapy Palliative Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C1285530
UMLS CUI [1,3]
C1265611
expected survival <12 weeks
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
subjects with known brain metastases
Description

Metastatic malignant neoplasm to brain

Data type

boolean

Alias
UMLS CUI [1]
C0220650
chemotherapy or radiation therapy within 21 days prior to visit 2 at the exception of palliative radiotherapy for bleeding or pain, which is allowed anytime, if not given on target lesions
Description

Chemotherapy Recent | Therapeutic radiology procedure Recent | Exception Therapeutic radiology procedure Palliative Hemorrhage | Exception Therapeutic radiology procedure Palliative Pain

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0332185
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1522449
UMLS CUI [3,3]
C1285530
UMLS CUI [3,4]
C0019080
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1522449
UMLS CUI [4,3]
C1285530
UMLS CUI [4,4]
C0030193
anti-egfr mabs within 14 days prior to visit 2
Description

Anti-egfr monoclonal antibody therapy Recent

Data type

boolean

Alias
UMLS CUI [1,1]
C4316122
UMLS CUI [1,2]
C0332185
major surgery within 4 weeks prior to visit 2 and subjects must have recovered from effects of major surgery
Description

Major surgery | Toxicity Due to Major surgery | Patient recovered

Data type

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2,1]
C0600688
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0679637
UMLS CUI [3]
C1115804
other protocol-defined exclusion criteria could apply
Description

Exclusion Criteria Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Carcinoma, Squamous Cell of Head and Neck NCT01417936

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Squamous cell carcinoma of the head and neck Initially | Recurrent Head and Neck Squamous Cell Carcinoma | Squamous cell carcinoma of mouth | Squamous cell carcinoma of oropharynx | Squamous cell carcinoma of the hypopharynx | Laryngeal Squamous Cell Carcinoma | Squamous cell carcinoma of the oral cavity recurrent | Oropharyngeal squamous cell carcinoma recurrent | Squamous cell carcinoma of the hypopharynx recurrent | Laryngeal squamous cell carcinoma recurrent
Item
histologically confirmed diagnosis initially or at relapse of scchn of the oral cavity, oropharynx, hypopharynx or larynx
boolean
C1168401 (UMLS CUI [1,1])
C0205265 (UMLS CUI [1,2])
C4524839 (UMLS CUI [2])
C0585362 (UMLS CUI [3])
C0280313 (UMLS CUI [4])
C0280321 (UMLS CUI [5])
C0280324 (UMLS CUI [6])
C0861556 (UMLS CUI [7])
C0280376 (UMLS CUI [8])
C0280392 (UMLS CUI [9])
C0280401 (UMLS CUI [10])
Recurrent Head and Neck Squamous Cell Carcinoma Inappropriate Curative Surgery | HEAD NECK CANCER SQUAMOUS CELL METASTATIC Inappropriate Curative Surgery | Recurrent Head and Neck Squamous Cell Carcinoma Inappropriate Therapeutic radiology procedure Curative | HEAD NECK CANCER SQUAMOUS CELL METASTATIC Inappropriate Therapeutic radiology procedure Curative | Recurrent Head and Neck Squamous Cell Carcinoma Inappropriate Chemoradiotherapy Curative | HEAD NECK CANCER SQUAMOUS CELL METASTATIC Inappropriate Chemoradiotherapy Curative
Item
recurrent and/or metastatic scchn not amenable to curative treatment with surgery and/or (chemo)radiation
boolean
C4524839 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C1511562 (UMLS CUI [1,3])
C0744620 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
C1511562 (UMLS CUI [2,3])
C4524839 (UMLS CUI [3,1])
C1548788 (UMLS CUI [3,2])
C1522449 (UMLS CUI [3,3])
C1276305 (UMLS CUI [3,4])
C0744620 (UMLS CUI [4,1])
C1548788 (UMLS CUI [4,2])
C1522449 (UMLS CUI [4,3])
C1276305 (UMLS CUI [4,4])
C4524839 (UMLS CUI [5,1])
C1548788 (UMLS CUI [5,2])
C0436307 (UMLS CUI [5,3])
C1276305 (UMLS CUI [5,4])
C0744620 (UMLS CUI [6,1])
C1548788 (UMLS CUI [6,2])
C0436307 (UMLS CUI [6,3])
C1276305 (UMLS CUI [6,4])
Anti-egfr monoclonal antibody therapy Palliative | Combined Modality Therapy | Chemotherapy | Therapeutic radiology procedure
Item
previous treatment with an anti-egfr monoclonal antibody (mab) in the palliative setting either as monotherapy or in combination with chemotherapy or radiotherapy and showing:
boolean
C4316122 (UMLS CUI [1,1])
C1285530 (UMLS CUI [1,2])
C0009429 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
C1522449 (UMLS CUI [4])
Benefit Clinical Anti-egfr monoclonal antibody therapy | Response Anti-egfr monoclonal antibody therapy | Partial response | In complete remission | Stable Disease
Item
documented clinical benefit or response for at least 8 weeks (pr, cr or sd) on the anti-egfr mab-based therapy and
boolean
C0814225 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C4316122 (UMLS CUI [1,3])
C1704632 (UMLS CUI [2,1])
C4316122 (UMLS CUI [2,2])
C1521726 (UMLS CUI [3])
C0677874 (UMLS CUI [4])
C0677946 (UMLS CUI [5])
Disease Progression CT scan | Disease Progression MRI | Status post Anti-egfr monoclonal antibody therapy
Item
documented disease progression (verified by computed tomography [ct] scan or magnetic resonance imaging [mri] according to recist (1.1) during or within 12 weeks following the last administration of anti-egfr mab
boolean
C0242656 (UMLS CUI [1,1])
C0040405 (UMLS CUI [1,2])
C0242656 (UMLS CUI [2,1])
C0024485 (UMLS CUI [2,2])
C0231290 (UMLS CUI [3,1])
C4316122 (UMLS CUI [3,2])
Neoplasm Amenable Biopsy | Neoplasm Biopsy Repeated
Item
accessible tumor for biopsy and subject acceptance of repeat tumor biopsies
boolean
C0027651 (UMLS CUI [1,1])
C3900053 (UMLS CUI [1,2])
C0005558 (UMLS CUI [1,3])
C0027651 (UMLS CUI [2,1])
C0005558 (UMLS CUI [2,2])
C0205341 (UMLS CUI [2,3])
Inclusion criteria Study Protocol
Item
other protocol-defined inclusion criteria could apply
boolean
C1512693 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Prior Chemotherapy Palliative Quantity
Item
more than 2 lines of prior chemotherapy in the palliative setting
boolean
C1514457 (UMLS CUI [1,1])
C1285530 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Life Expectancy
Item
expected survival <12 weeks
boolean
C0023671 (UMLS CUI [1])
Metastatic malignant neoplasm to brain
Item
subjects with known brain metastases
boolean
C0220650 (UMLS CUI [1])
Chemotherapy Recent | Therapeutic radiology procedure Recent | Exception Therapeutic radiology procedure Palliative Hemorrhage | Exception Therapeutic radiology procedure Palliative Pain
Item
chemotherapy or radiation therapy within 21 days prior to visit 2 at the exception of palliative radiotherapy for bleeding or pain, which is allowed anytime, if not given on target lesions
boolean
C0392920 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1522449 (UMLS CUI [3,2])
C1285530 (UMLS CUI [3,3])
C0019080 (UMLS CUI [3,4])
C1705847 (UMLS CUI [4,1])
C1522449 (UMLS CUI [4,2])
C1285530 (UMLS CUI [4,3])
C0030193 (UMLS CUI [4,4])
Anti-egfr monoclonal antibody therapy Recent
Item
anti-egfr mabs within 14 days prior to visit 2
boolean
C4316122 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Major surgery | Toxicity Due to Major surgery | Patient recovered
Item
major surgery within 4 weeks prior to visit 2 and subjects must have recovered from effects of major surgery
boolean
C0679637 (UMLS CUI [1])
C0600688 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0679637 (UMLS CUI [2,3])
C1115804 (UMLS CUI [3])
Exclusion Criteria Study Protocol
Item
other protocol-defined exclusion criteria could apply
boolean
C0680251 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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