ID

37227

Beschrijving

Study of the Glutaminase Inhibitor CB-839 in Solid Tumors; ODM derived from: https://clinicaltrials.gov/show/NCT02071862

Link

https://clinicaltrials.gov/show/NCT02071862

Trefwoorden

Versies (1)
  1. 09-07-19 09-07-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

9 juli 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Solid Tumors NCT02071862

Engels

Eligibility Solid Tumors NCT02071862

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
advanced malignancy that is relapsed and/or refractory to all available therapies that will confer clinical benefit. newly diagnosed patients who refuse standard treatment regimens are also eligible
Beschrijving

Malignant Neoplasms Advanced Recurrent | Malignant Neoplasms Advanced Unresponsive to Treatment | Therapy All Benefit | Patients Standard therapy Refused

Datatype

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C0277556
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C0205179
UMLS CUI [2,3]
C0205269
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0444868
UMLS CUI [3,3]
C0814225
UMLS CUI [4,1]
C0030705
UMLS CUI [4,2]
C2936643
UMLS CUI [4,3]
C1705116
eastern cooperative oncology group (ecog) performance status of 0-1
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy of at least 3 months
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
adequate hepatic, renal, cardiac, and hematologic function
Beschrijving

Liver function | Renal function | Cardiac function | Hematologic function

Datatype

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232164
UMLS CUI [4]
C0221130
measurable disease by recist criteria
Beschrijving

Measurable Disease

Datatype

boolean

Alias
UMLS CUI [1]
C1513041
ability to provide written informed consent in accordance with federal, local, and institutional guidelines
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
any other current or previous malignancy
Beschrijving

Cancer Other

Datatype

boolean

Alias
UMLS CUI [1]
C1707251
chemotherapy, radiation therapy, hormonal therapy, immunotherapy or biological therapy, or investigational agent within 21 days
Beschrijving

Chemotherapy | Therapeutic radiology procedure | Hormone Therapy | Immunotherapy | Biological treatment | Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0279025
UMLS CUI [4]
C0021083
UMLS CUI [5]
C1531518
UMLS CUI [6]
C0013230
unable to receive medications oral medications
Beschrijving

Oral medication Receive Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0175795
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C1299582
major surgery within 28 days before cycle 1 day 1
Beschrijving

Major surgery

Datatype

boolean

Alias
UMLS CUI [1]
C0679637
active infection requiring within 2 weeks prior to first dose of study drug
Beschrijving

Communicable Disease Treatment required for

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0332121
patients who have hiv, hepatitis a, b or c or cmv reactivation
Beschrijving

HIV Infection | Hepatitis A | Hepatitis B | Hepatitis C | Cytomegalovirus Infection Reactivation

Datatype

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0019159
UMLS CUI [3]
C0019163
UMLS CUI [4]
C0019196
UMLS CUI [5,1]
C0010823
UMLS CUI [5,2]
C4086768
significant neurotoxicity/neuropathy (grade 3 or higher) within 14 days of first dose of study drug
Beschrijving

Neurotoxicity CTCAE Grades | Neuropathy CTCAE Grades

Datatype

boolean

Alias
UMLS CUI [1,1]
C0235032
UMLS CUI [1,2]
C1516728
UMLS CUI [2,1]
C0442874
UMLS CUI [2,2]
C1516728
conditions that could interfere with treatment or protocol-related procedures
Beschrijving

Condition Interferes with Therapy | Condition Interferes with Interventional procedure

Datatype

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0087111
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0184661
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Similar models

Eligibility Solid Tumors NCT02071862

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Malignant Neoplasms Advanced Recurrent | Malignant Neoplasms Advanced Unresponsive to Treatment | Therapy All Benefit | Patients Standard therapy Refused
Item
advanced malignancy that is relapsed and/or refractory to all available therapies that will confer clinical benefit. newly diagnosed patients who refuse standard treatment regimens are also eligible
boolean
C0006826 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0277556 (UMLS CUI [1,3])
C0006826 (UMLS CUI [2,1])
C0205179 (UMLS CUI [2,2])
C0205269 (UMLS CUI [2,3])
C0087111 (UMLS CUI [3,1])
C0444868 (UMLS CUI [3,2])
C0814225 (UMLS CUI [3,3])
C0030705 (UMLS CUI [4,1])
C2936643 (UMLS CUI [4,2])
C1705116 (UMLS CUI [4,3])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of 0-1
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of at least 3 months
boolean
C0023671 (UMLS CUI [1])
Liver function | Renal function | Cardiac function | Hematologic function
Item
adequate hepatic, renal, cardiac, and hematologic function
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232164 (UMLS CUI [3])
C0221130 (UMLS CUI [4])
Measurable Disease
Item
measurable disease by recist criteria
boolean
C1513041 (UMLS CUI [1])
Informed Consent
Item
ability to provide written informed consent in accordance with federal, local, and institutional guidelines
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cancer Other
Item
any other current or previous malignancy
boolean
C1707251 (UMLS CUI [1])
Chemotherapy | Therapeutic radiology procedure | Hormone Therapy | Immunotherapy | Biological treatment | Investigational New Drugs
Item
chemotherapy, radiation therapy, hormonal therapy, immunotherapy or biological therapy, or investigational agent within 21 days
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0279025 (UMLS CUI [3])
C0021083 (UMLS CUI [4])
C1531518 (UMLS CUI [5])
C0013230 (UMLS CUI [6])
Oral medication Receive Unable
Item
unable to receive medications oral medications
boolean
C0175795 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Major surgery
Item
major surgery within 28 days before cycle 1 day 1
boolean
C0679637 (UMLS CUI [1])
Communicable Disease Treatment required for
Item
active infection requiring within 2 weeks prior to first dose of study drug
boolean
C0009450 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
HIV Infection | Hepatitis A | Hepatitis B | Hepatitis C | Cytomegalovirus Infection Reactivation
Item
patients who have hiv, hepatitis a, b or c or cmv reactivation
boolean
C0019693 (UMLS CUI [1])
C0019159 (UMLS CUI [2])
C0019163 (UMLS CUI [3])
C0019196 (UMLS CUI [4])
C0010823 (UMLS CUI [5,1])
C4086768 (UMLS CUI [5,2])
Neurotoxicity CTCAE Grades | Neuropathy CTCAE Grades
Item
significant neurotoxicity/neuropathy (grade 3 or higher) within 14 days of first dose of study drug
boolean
C0235032 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C0442874 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
Condition Interferes with Therapy | Condition Interferes with Interventional procedure
Item
conditions that could interfere with treatment or protocol-related procedures
boolean
C0348080 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0184661 (UMLS CUI [2,3])
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