ID

37228

Description

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GS-5829 in Adults With Advanced Solid Tumors and Lymphomas; ODM derived from: https://clinicaltrials.gov/show/NCT02392611

Link

https://clinicaltrials.gov/show/NCT02392611

Keywords

Versions (1)
  1. 7/9/19 7/9/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 9, 2019

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Solid Tumors NCT02392611

English

Eligibility Solid Tumors NCT02392611

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed advanced malignant solid tumor or lymphoma that is refractory to or intolerant of standard therapy or for which no standard therapy is available
Description

Standard of Care Refractory Advanced Malignant Solid Neoplasm | Standard of Care Refractory Lymphoma Advanced | Intolerance Standard of Care | Standard of Care Unavailable

Data type

boolean

Alias
UMLS CUI [1,1]
C2936643
UMLS CUI [1,2]
C0205269
UMLS CUI [1,3]
C4329281
UMLS CUI [2,1]
C2936643
UMLS CUI [2,2]
C0205269
UMLS CUI [2,3]
C0024299
UMLS CUI [2,4]
C0205179
UMLS CUI [3,1]
C0231199
UMLS CUI [3,2]
C2936643
UMLS CUI [4,1]
C2936643
UMLS CUI [4,2]
C0686905
eastern cooperative oncology group (ecog) performance status of ≤ 1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
adequate organ function defined as follows:
Description

Organ function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
hematologic: platelets ≥ 100 x 10^9/l; hemoglobin ≥ 9.0 g/ dl; absolute neutrophil count (anc) ≥ 1.5 x 10^9/l (without platelet transfusion or any growth factors within previous 7 days of the hematologic laboratory values obtained at screening visit)
Description

Hematologic function | Platelet Count measurement | Hemoglobin measurement | Absolute neutrophil count | Platelet Transfusion Absent | Growth Factor Absent

Data type

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0518015
UMLS CUI [4]
C0948762
UMLS CUI [5,1]
C0086818
UMLS CUI [5,2]
C0332197
UMLS CUI [6,1]
C0018284
UMLS CUI [6,2]
C0332197
hepatic: aspartate transaminase (ast) / alanine transaminase (alt) ≤ 2.5 x upper limit of normal (uln) (if liver metastases are present, ≤ 5 x uln); total or conjugated bilirubin ≤ 1.5 x uln
Description

Liver function | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver | Serum total bilirubin measurement | Serum conjugated bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201836
UMLS CUI [4]
C0494165
UMLS CUI [5]
C1278039
UMLS CUI [6]
C1278038
renal: serum creatinine ≤ 1.5 x uln or creatinine clearance (crcl) ≥ 60 ml/min as calculated by the cockcroft-gault method
Description

Renal function | Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula

Data type

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
UMLS CUI [3]
C2711451
coagulation: international normalized ratio (inr) ≤ 1.2
Description

Coagulation function analysis | International Normalized Ratio

Data type

boolean

Alias
UMLS CUI [1]
C3516400
UMLS CUI [2]
C0525032
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
known brain metastasis or leptomeningeal disease
Description

Metastatic malignant neoplasm to brain | Leptomeningeal disease

Data type

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2]
C0751297
myocardial infarction, symptomatic congestive heart failure (new york heart association classification > class ii), unstable angina, or serious uncontrolled cardiac arrhythmia within the last 6 months of study day 1
Description

Myocardial Infarction | Symptomatic congestive heart failure New York Heart Association Classification | Angina, Unstable | Cardiac Arrhythmia Serious Uncontrolled

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2,1]
C0742758
UMLS CUI [2,2]
C1275491
UMLS CUI [3]
C0002965
UMLS CUI [4,1]
C0003811
UMLS CUI [4,2]
C0205404
UMLS CUI [4,3]
C0205318
major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (ie, larger than what is required for placement of central venous access, percutaneous feeding tube, or biopsy) within 28 days of first dose of study drug
Description

Major surgery Involvement with General Anesthesia | Major surgery Involvement with Incision Significant

Data type

boolean

Alias
UMLS CUI [1,1]
C0679637
UMLS CUI [1,2]
C1314939
UMLS CUI [1,3]
C0002915
UMLS CUI [2,1]
C0679637
UMLS CUI [2,2]
C1314939
UMLS CUI [2,3]
C0184898
UMLS CUI [2,4]
C0750502
history of long qt syndrome or whose corrected qt interval (qtc) measured (fridericia method) at screening is prolonged (> 450 ms for males and > 470 ms for females). individuals who screen-fail due to this criterion are not eligible to be re-screened
Description

Long QT Syndrome | Prolonged QTc interval Fridericia formula | Gender

Data type

boolean

Alias
UMLS CUI [1]
C0023976
UMLS CUI [2,1]
C1560305
UMLS CUI [2,2]
C4037934
UMLS CUI [3]
C0079399
clinically significant bleeding within 28 days of study day 1
Description

Hemorrhage Clinical Significance

Data type

boolean

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C2826293
known human immunodeficiency virus (hiv) infection
Description

HIV Infection

Data type

boolean

Alias
UMLS CUI [1]
C0019693
hbsag positive
Description

Hepatitis B surface antigen positive

Data type

boolean

Alias
UMLS CUI [1]
C0149709
hepatitis c virus (hcv) antibody positive
Description

Hepatitis C antibody positive

Data type

boolean

Alias
UMLS CUI [1]
C0281863
no active anticoagulation within 7 days of study day 1; including acetylsalicylic acid, low molecular weight heparin, or warfarin.
Description

Anticoagulation Therapy | Aspirin | Heparin, Low-Molecular-Weight | Warfarin

Data type

boolean

Alias
UMLS CUI [1]
C0003281
UMLS CUI [2]
C0004057
UMLS CUI [3]
C0019139
UMLS CUI [4]
C0043031
Back to the top of the page

Similar models

Eligibility Solid Tumors NCT02392611

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Standard of Care Refractory Advanced Malignant Solid Neoplasm | Standard of Care Refractory Lymphoma Advanced | Intolerance Standard of Care | Standard of Care Unavailable
Item
histologically or cytologically confirmed advanced malignant solid tumor or lymphoma that is refractory to or intolerant of standard therapy or for which no standard therapy is available
boolean
C2936643 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
C4329281 (UMLS CUI [1,3])
C2936643 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
C0024299 (UMLS CUI [2,3])
C0205179 (UMLS CUI [2,4])
C0231199 (UMLS CUI [3,1])
C2936643 (UMLS CUI [3,2])
C2936643 (UMLS CUI [4,1])
C0686905 (UMLS CUI [4,2])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of ≤ 1
boolean
C1520224 (UMLS CUI [1])
Organ function
Item
adequate organ function defined as follows:
boolean
C0678852 (UMLS CUI [1])
Hematologic function | Platelet Count measurement | Hemoglobin measurement | Absolute neutrophil count | Platelet Transfusion Absent | Growth Factor Absent
Item
hematologic: platelets ≥ 100 x 10^9/l; hemoglobin ≥ 9.0 g/ dl; absolute neutrophil count (anc) ≥ 1.5 x 10^9/l (without platelet transfusion or any growth factors within previous 7 days of the hematologic laboratory values obtained at screening visit)
boolean
C0221130 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
C0948762 (UMLS CUI [4])
C0086818 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0018284 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
Liver function | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver | Serum total bilirubin measurement | Serum conjugated bilirubin measurement
Item
hepatic: aspartate transaminase (ast) / alanine transaminase (alt) ≤ 2.5 x upper limit of normal (uln) (if liver metastases are present, ≤ 5 x uln); total or conjugated bilirubin ≤ 1.5 x uln
boolean
C0232741 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0494165 (UMLS CUI [4])
C1278039 (UMLS CUI [5])
C1278038 (UMLS CUI [6])
Renal function | Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
renal: serum creatinine ≤ 1.5 x uln or creatinine clearance (crcl) ≥ 60 ml/min as calculated by the cockcroft-gault method
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C2711451 (UMLS CUI [3])
Coagulation function analysis | International Normalized Ratio
Item
coagulation: international normalized ratio (inr) ≤ 1.2
boolean
C3516400 (UMLS CUI [1])
C0525032 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Metastatic malignant neoplasm to brain | Leptomeningeal disease
Item
known brain metastasis or leptomeningeal disease
boolean
C0220650 (UMLS CUI [1])
C0751297 (UMLS CUI [2])
Myocardial Infarction | Symptomatic congestive heart failure New York Heart Association Classification | Angina, Unstable | Cardiac Arrhythmia Serious Uncontrolled
Item
myocardial infarction, symptomatic congestive heart failure (new york heart association classification > class ii), unstable angina, or serious uncontrolled cardiac arrhythmia within the last 6 months of study day 1
boolean
C0027051 (UMLS CUI [1])
C0742758 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C0002965 (UMLS CUI [3])
C0003811 (UMLS CUI [4,1])
C0205404 (UMLS CUI [4,2])
C0205318 (UMLS CUI [4,3])
Major surgery Involvement with General Anesthesia | Major surgery Involvement with Incision Significant
Item
major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (ie, larger than what is required for placement of central venous access, percutaneous feeding tube, or biopsy) within 28 days of first dose of study drug
boolean
C0679637 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C0002915 (UMLS CUI [1,3])
C0679637 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
C0184898 (UMLS CUI [2,3])
C0750502 (UMLS CUI [2,4])
Long QT Syndrome | Prolonged QTc interval Fridericia formula | Gender
Item
history of long qt syndrome or whose corrected qt interval (qtc) measured (fridericia method) at screening is prolonged (> 450 ms for males and > 470 ms for females). individuals who screen-fail due to this criterion are not eligible to be re-screened
boolean
C0023976 (UMLS CUI [1])
C1560305 (UMLS CUI [2,1])
C4037934 (UMLS CUI [2,2])
C0079399 (UMLS CUI [3])
Hemorrhage Clinical Significance
Item
clinically significant bleeding within 28 days of study day 1
boolean
C0019080 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
HIV Infection
Item
known human immunodeficiency virus (hiv) infection
boolean
C0019693 (UMLS CUI [1])
Hepatitis B surface antigen positive
Item
hbsag positive
boolean
C0149709 (UMLS CUI [1])
Hepatitis C antibody positive
Item
hepatitis c virus (hcv) antibody positive
boolean
C0281863 (UMLS CUI [1])
Anticoagulation Therapy | Aspirin | Heparin, Low-Molecular-Weight | Warfarin
Item
no active anticoagulation within 7 days of study day 1; including acetylsalicylic acid, low molecular weight heparin, or warfarin.
boolean
C0003281 (UMLS CUI [1])
C0004057 (UMLS CUI [2])
C0019139 (UMLS CUI [3])
C0043031 (UMLS CUI [4])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial