ID

15170

Description

A Study Evaluating Safety and Pharmacokinetics of ABBV-221 in Subjects With Advanced Solid Tumor Types Likely to Exhibit Elevated Levels of Epidermal Growth Factor Receptor; ODM derived from: https://clinicaltrials.gov/show/NCT02365662

Lien

https://clinicaltrials.gov/show/NCT02365662

Mots-clés

Versions (1)
  1. 20/05/2016 20/05/2016 -
Téléchargé le

20 mai 2016

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Head and Neck Squamous Cell Carcinoma NCT02365662

Anglais

Eligibility Head and Neck Squamous Cell Carcinoma NCT02365662

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
eastern cooperative oncology group (ecog) performance status 0 or 2.
Description

ECOG performance status

Type de données

boolean

Alias
UMLS CUI [1]
C1520224
has a solid tumor likely to exhibit elevated levels of egfr (e.g. head and neck squamous cell carcinoma, non-small cell lung cancer, triple negative breast cancer
Description

Solid tumour | Estimated Glomerular Filtration Rate Level Elevated | Squamous cell carcinoma of the head and neck | Non-Small Cell Lung Carcinoma | Triple-Negative Breast Cancer Finding

Type de données

boolean

Alias
UMLS CUI [1]
C0280100
UMLS CUI [2,1]
C3811844
UMLS CUI [2,2]
C0441889
UMLS CUI [2,3]
C3163633
UMLS CUI [3]
C1168401
UMLS CUI [4]
C0007131
UMLS CUI [5]
C2348819
,colorectal carcinoma and glioblastoma multiforme).
Description

Colorectal Carcinoma | Glioblastoma Multiforme

Type de données

boolean

Alias
UMLS CUI [1]
C0009402
UMLS CUI [2]
C1621958
has an archived, diagnostic tumor tissue available for analysis.
Description

Tumor tissue sample Diagnostic archived Availability Analysis

Type de données

boolean

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C0348026
UMLS CUI [1,3]
C1548398
UMLS CUI [1,4]
C0470187
UMLS CUI [1,5]
C0936012
has adequate hematologic, renal, cardiac and hepatic function.
Description

Hematologic function | Renal function | Cardiac function | Liver function

Type de données

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232164
UMLS CUI [4]
C0232741
expanded safety cohort participants must have confirmed metastatic lung cancer and progressed after receiving prior platinum-containing chemotherapy.
Description

Cohort Safety Expanded | Secondary malignant neoplasm of lung | Disease Progression | Prior Chemotherapy Containing Platinum

Type de données

boolean

Alias
UMLS CUI [1,1]
C0599755
UMLS CUI [1,2]
C0036043
UMLS CUI [1,3]
C0205229
UMLS CUI [2]
C0153676
UMLS CUI [3]
C0242656
UMLS CUI [4,1]
C1514457
UMLS CUI [4,2]
C0332256
UMLS CUI [4,3]
C0032207
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previously received an egfr-directed monoclonal antibody within the past 4 weeks.
Description

Monoclonal Antibodies Previous As directed for Estimated Glomerular Filtration Rate

Type de données

boolean

Alias
UMLS CUI [1,1]
C0003250
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C1720148
UMLS CUI [1,4]
C3811844
has unresolved, clinically significant toxicities from prior anti-cancer therapy defined as > grade 1 on common terminology criteria for adverse events.
Description

Cancer treatment Previous Causing Toxic effect | Common Terminology Criteria for Adverse Events

Type de données

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0678227
UMLS CUI [1,4]
C0600688
UMLS CUI [2]
C3888020
history of major immunologic reaction to any igg containing agent.
Description

Immunologic reaction Major Pharmacologic Substance Containing Immunoglobulin G

Type de données

boolean

Alias
UMLS CUI [1,1]
C0301873
UMLS CUI [1,2]
C0205164
UMLS CUI [1,3]
C1254351
UMLS CUI [1,4]
C0332256
UMLS CUI [1,5]
C0020852
any medical condition which in the opinion of the investigator places the participant at an unacceptably high risk for toxicities.
Description

Medical condition High risk of Toxic effect

Type de données

boolean

Alias
UMLS CUI [1,1]
C1699700
UMLS CUI [1,2]
C0332167
UMLS CUI [1,3]
C0600688
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Similar models

Eligibility Head and Neck Squamous Cell Carcinoma NCT02365662

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status 0 or 2.
boolean
C1520224 (UMLS CUI [1])
Solid tumour | Estimated Glomerular Filtration Rate Level Elevated | Squamous cell carcinoma of the head and neck | Non-Small Cell Lung Carcinoma | Triple-Negative Breast Cancer Finding
Item
has a solid tumor likely to exhibit elevated levels of egfr (e.g. head and neck squamous cell carcinoma, non-small cell lung cancer, triple negative breast cancer
boolean
C0280100 (UMLS CUI [1])
C3811844 (UMLS CUI [2,1])
C0441889 (UMLS CUI [2,2])
C3163633 (UMLS CUI [2,3])
C1168401 (UMLS CUI [3])
C0007131 (UMLS CUI [4])
C2348819 (UMLS CUI [5])
Colorectal Carcinoma | Glioblastoma Multiforme
Item
,colorectal carcinoma and glioblastoma multiforme).
boolean
C0009402 (UMLS CUI [1])
C1621958 (UMLS CUI [2])
Tumor tissue sample Diagnostic archived Availability Analysis
Item
has an archived, diagnostic tumor tissue available for analysis.
boolean
C0475358 (UMLS CUI [1,1])
C0348026 (UMLS CUI [1,2])
C1548398 (UMLS CUI [1,3])
C0470187 (UMLS CUI [1,4])
C0936012 (UMLS CUI [1,5])
Hematologic function | Renal function | Cardiac function | Liver function
Item
has adequate hematologic, renal, cardiac and hepatic function.
boolean
C0221130 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232164 (UMLS CUI [3])
C0232741 (UMLS CUI [4])
Cohort Safety Expanded | Secondary malignant neoplasm of lung | Disease Progression | Prior Chemotherapy Containing Platinum
Item
expanded safety cohort participants must have confirmed metastatic lung cancer and progressed after receiving prior platinum-containing chemotherapy.
boolean
C0599755 (UMLS CUI [1,1])
C0036043 (UMLS CUI [1,2])
C0205229 (UMLS CUI [1,3])
C0153676 (UMLS CUI [2])
C0242656 (UMLS CUI [3])
C1514457 (UMLS CUI [4,1])
C0332256 (UMLS CUI [4,2])
C0032207 (UMLS CUI [4,3])
Item Group
C0680251 (UMLS CUI)
Monoclonal Antibodies Previous As directed for Estimated Glomerular Filtration Rate
Item
previously received an egfr-directed monoclonal antibody within the past 4 weeks.
boolean
C0003250 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C1720148 (UMLS CUI [1,3])
C3811844 (UMLS CUI [1,4])
Cancer treatment Previous Causing Toxic effect | Common Terminology Criteria for Adverse Events
Item
has unresolved, clinically significant toxicities from prior anti-cancer therapy defined as > grade 1 on common terminology criteria for adverse events.
boolean
C0920425 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0678227 (UMLS CUI [1,3])
C0600688 (UMLS CUI [1,4])
C3888020 (UMLS CUI [2])
Immunologic reaction Major Pharmacologic Substance Containing Immunoglobulin G
Item
history of major immunologic reaction to any igg containing agent.
boolean
C0301873 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C1254351 (UMLS CUI [1,3])
C0332256 (UMLS CUI [1,4])
C0020852 (UMLS CUI [1,5])
Medical condition High risk of Toxic effect
Item
any medical condition which in the opinion of the investigator places the participant at an unacceptably high risk for toxicities.
boolean
C1699700 (UMLS CUI [1,1])
C0332167 (UMLS CUI [1,2])
C0600688 (UMLS CUI [1,3])
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