ID

17963

Description

A Phase 2, Open-Label, Multicenter Study of the GARFT Inhibitor in Patients With Metastatic Non-Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00090701

Link

https://clinicaltrials.gov/show/NCT00090701

Keywords

Versions (1)
  1. 10/11/16 10/11/16 -
Uploaded on

October 11, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Lung Neoplasms NCT00090701

English

Eligibility Lung Neoplasms NCT00090701

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
presence of measurable, metastatic non-small cell lung cancer (histologically or cytologically confirmed at the time of original diagnosis)
Description

Non-small cell lung cancer metastatic Measurable

Data type

boolean

Alias
UMLS CUI [1,1]
C0278987
UMLS CUI [1,2]
C1513040
treatment failure (recurrence, disease progression, or intolerable toxicity) of 2 or 3 prior systemic treatments. (note: no more than 3 prior systemic regimens for non-small cell lung cancer including adjuvant chemotherapy)
Description

systemic therapy Quantity failed | Recurrence | Disease Progression | Toxic effect | systemic therapy Quantity Non-Small Cell Lung Carcinoma | Chemotherapy, Adjuvant

Data type

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0231175
UMLS CUI [2]
C0034897
UMLS CUI [3]
C0242656
UMLS CUI [4]
C0600688
UMLS CUI [5,1]
C1515119
UMLS CUI [5,2]
C1265611
UMLS CUI [5,3]
C0007131
UMLS CUI [6]
C0085533
capable of understanding the nature of the trial and willing to give written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
eastern cooperative oncology group (ecog) performance status of 0, 1 or 2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
hemoglobin level of >=9 g/dl, absolute granulocyte count of >=1.5 × 109/l, and platelet count of >=100 × 109/l
Description

Hemoglobin | Granulocyte count | Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0019046
UMLS CUI [2]
C0857490
UMLS CUI [3]
C0032181
adequate renal function, as documented by a serum creatinine level of <=1.5 times the institutional upper limit of normal (uln) and a measured or calculated creatinine clearance of >=60 ml/min
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0373595
UMLS CUI [4]
C2711451
adequate liver function, as demonstrated by a total bilirubin level of <=1.5 times uln; levels of serum glutamate oxaloacetic transaminase (sgot) (aspartate aminotransferase [ast]) and serum glutamate pyruvate transaminase (sgpt) (alanine aminotransferase [alt]) <=2 times uln. if the patient has liver involvement then ast and alt should be <=5 times uln
Description

Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Liver Involvement

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
UMLS CUI [5,1]
C0023884
UMLS CUI [5,2]
C1314939
for men with partners of child-bearing potential and all women of childbearing potential, willingness to use adequate contraception or practice abstinence during the course of the study at least 18 years of age
Description

Gender Partner Childbearing Potential Contraceptive methods | Childbearing Potential Contraceptive methods | Childbearing Potential Sexual Abstinence | Age

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0682323
UMLS CUI [1,3]
C3831118
UMLS CUI [1,4]
C0700589
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0036899
UMLS CUI [4]
C0001779
life expectancy estimated at greater than 12 weeks
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of blood transfusion within the last 14 days
Description

Blood Transfusion

Data type

boolean

Alias
UMLS CUI [1]
C0005841
need of concurrent administration of allopurinol
Description

Allopurinol Patient need for

Data type

boolean

Alias
UMLS CUI [1,1]
C0002144
UMLS CUI [1,2]
C0686904
history of radiotherapy or chemotherapy within 4 weeks (nitrosourea or mitomycin c within 6 weeks) of the anticipated first day of dosing (patient must be fully recovered from the acute effects of any prior chemotherapy or radiotherapy)
Description

Therapeutic radiology procedure | Chemotherapy | Nitrosourea | Mitomycin | Toxic effect Patient Recovered

Data type

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2]
C0392920
UMLS CUI [3]
C0028210
UMLS CUI [4]
C0002475
UMLS CUI [5,1]
C0600688
UMLS CUI [5,2]
C0030705
UMLS CUI [5,3]
C0521108
any psychological or sociological condition, addictive disorder, or family problems that might preclude compliance with the protocol
Description

Condition Excludes Protocol Compliance | Addictive Behavior Excludes Protocol Compliance | Family problems Exclude Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C0085281
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C0525058
UMLS CUI [3,1]
C0424960
UMLS CUI [3,2]
C0332196
UMLS CUI [3,3]
C0525058
any unstable or severe intercurrent medical condition that in the opinion of the investigator might interfere with achievement of study objectives
Description

medical condition Unstable Interferes with Study Protocol | medical condition Severe Interferes with Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0443343
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C2348563
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0521102
UMLS CUI [2,4]
C2348563
receipt of an investigational agent within 28 days before the anticipated first day of dosing (patient must have recovered from all acute effects of previously administered investigational agents)
Description

Investigational New Drugs | adverse effects Patient Recovered

Data type

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2,1]
C0001688
UMLS CUI [2,2]
C0030705
UMLS CUI [2,3]
C0521108
pregnant or breast-feeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
previous treatment with garft inhibitors
Description

Glycinamide Ribonucleotide Formyltransferase Inhibitor

Data type

boolean

Alias
UMLS CUI [1]
C1512220
history of radiation therapy to more than 40% of the marrow space
Description

Therapeutic radiology procedure Bone Marrow Percentage

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0005953
UMLS CUI [1,3]
C0439165
history of a malignancy (other than non-small cell lung cancer) except those treated with curative intent for skin cancer (other than melanoma) or in situ breast or cervical cancer or those treated with curative intent for any other cancer with no evidence of disease for 5 years
Description

Malignant Neoplasms | Non-Small Cell Lung Carcinoma | Skin carcinoma curative treatment | Stage 0 Breast Carcinoma curative treatment | Carcinoma in situ of uterine cervix curative treatment | Malignant Neoplasms curative treatment

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0007131
UMLS CUI [3,1]
C0699893
UMLS CUI [3,2]
C1273390
UMLS CUI [4,1]
C0154084
UMLS CUI [4,2]
C1273390
UMLS CUI [5,1]
C0851140
UMLS CUI [5,2]
C1273390
UMLS CUI [6,1]
C0006826
UMLS CUI [6,2]
C1273390
active brain metastases (requiring treatment or progressing)
Description

Metastatic malignant neoplasm to brain Requirement Therapeutic procedure | Disease Progression

Data type

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0087111
UMLS CUI [2]
C0242656
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Similar models

Eligibility Lung Neoplasms NCT00090701

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Non-small cell lung cancer metastatic Measurable
Item
presence of measurable, metastatic non-small cell lung cancer (histologically or cytologically confirmed at the time of original diagnosis)
boolean
C0278987 (UMLS CUI [1,1])
C1513040 (UMLS CUI [1,2])
systemic therapy Quantity failed | Recurrence | Disease Progression | Toxic effect | systemic therapy Quantity Non-Small Cell Lung Carcinoma | Chemotherapy, Adjuvant
Item
treatment failure (recurrence, disease progression, or intolerable toxicity) of 2 or 3 prior systemic treatments. (note: no more than 3 prior systemic regimens for non-small cell lung cancer including adjuvant chemotherapy)
boolean
C1515119 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
C0034897 (UMLS CUI [2])
C0242656 (UMLS CUI [3])
C0600688 (UMLS CUI [4])
C1515119 (UMLS CUI [5,1])
C1265611 (UMLS CUI [5,2])
C0007131 (UMLS CUI [5,3])
C0085533 (UMLS CUI [6])
Informed Consent
Item
capable of understanding the nature of the trial and willing to give written informed consent
boolean
C0021430 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of 0, 1 or 2
boolean
C1520224 (UMLS CUI [1])
Hemoglobin | Granulocyte count | Platelet Count measurement
Item
hemoglobin level of >=9 g/dl, absolute granulocyte count of >=1.5 × 109/l, and platelet count of >=100 × 109/l
boolean
C0019046 (UMLS CUI [1])
C0857490 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Renal function | Creatinine measurement, serum | Creatinine clearance measurement | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
adequate renal function, as documented by a serum creatinine level of <=1.5 times the institutional upper limit of normal (uln) and a measured or calculated creatinine clearance of >=60 ml/min
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0373595 (UMLS CUI [3])
C2711451 (UMLS CUI [4])
Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Liver Involvement
Item
adequate liver function, as demonstrated by a total bilirubin level of <=1.5 times uln; levels of serum glutamate oxaloacetic transaminase (sgot) (aspartate aminotransferase [ast]) and serum glutamate pyruvate transaminase (sgpt) (alanine aminotransferase [alt]) <=2 times uln. if the patient has liver involvement then ast and alt should be <=5 times uln
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0023884 (UMLS CUI [5,1])
C1314939 (UMLS CUI [5,2])
Gender Partner Childbearing Potential Contraceptive methods | Childbearing Potential Contraceptive methods | Childbearing Potential Sexual Abstinence | Age
Item
for men with partners of child-bearing potential and all women of childbearing potential, willingness to use adequate contraception or practice abstinence during the course of the study at least 18 years of age
boolean
C0079399 (UMLS CUI [1,1])
C0682323 (UMLS CUI [1,2])
C3831118 (UMLS CUI [1,3])
C0700589 (UMLS CUI [1,4])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0036899 (UMLS CUI [3,2])
C0001779 (UMLS CUI [4])
Life Expectancy
Item
life expectancy estimated at greater than 12 weeks
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Blood Transfusion
Item
history of blood transfusion within the last 14 days
boolean
C0005841 (UMLS CUI [1])
Allopurinol Patient need for
Item
need of concurrent administration of allopurinol
boolean
C0002144 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
Therapeutic radiology procedure | Chemotherapy | Nitrosourea | Mitomycin | Toxic effect Patient Recovered
Item
history of radiotherapy or chemotherapy within 4 weeks (nitrosourea or mitomycin c within 6 weeks) of the anticipated first day of dosing (patient must be fully recovered from the acute effects of any prior chemotherapy or radiotherapy)
boolean
C1522449 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
C0028210 (UMLS CUI [3])
C0002475 (UMLS CUI [4])
C0600688 (UMLS CUI [5,1])
C0030705 (UMLS CUI [5,2])
C0521108 (UMLS CUI [5,3])
Condition Excludes Protocol Compliance | Addictive Behavior Excludes Protocol Compliance | Family problems Exclude Protocol Compliance
Item
any psychological or sociological condition, addictive disorder, or family problems that might preclude compliance with the protocol
boolean
C0348080 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0085281 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C0424960 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
medical condition Unstable Interferes with Study Protocol | medical condition Severe Interferes with Study Protocol
Item
any unstable or severe intercurrent medical condition that in the opinion of the investigator might interfere with achievement of study objectives
boolean
C3843040 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C2348563 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C2348563 (UMLS CUI [2,4])
Investigational New Drugs | adverse effects Patient Recovered
Item
receipt of an investigational agent within 28 days before the anticipated first day of dosing (patient must have recovered from all acute effects of previously administered investigational agents)
boolean
C0013230 (UMLS CUI [1])
C0001688 (UMLS CUI [2,1])
C0030705 (UMLS CUI [2,2])
C0521108 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Glycinamide Ribonucleotide Formyltransferase Inhibitor
Item
previous treatment with garft inhibitors
boolean
C1512220 (UMLS CUI [1])
Therapeutic radiology procedure Bone Marrow Percentage
Item
history of radiation therapy to more than 40% of the marrow space
boolean
C1522449 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
Malignant Neoplasms | Non-Small Cell Lung Carcinoma | Skin carcinoma curative treatment | Stage 0 Breast Carcinoma curative treatment | Carcinoma in situ of uterine cervix curative treatment | Malignant Neoplasms curative treatment
Item
history of a malignancy (other than non-small cell lung cancer) except those treated with curative intent for skin cancer (other than melanoma) or in situ breast or cervical cancer or those treated with curative intent for any other cancer with no evidence of disease for 5 years
boolean
C0006826 (UMLS CUI [1])
C0007131 (UMLS CUI [2])
C0699893 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C0154084 (UMLS CUI [4,1])
C1273390 (UMLS CUI [4,2])
C0851140 (UMLS CUI [5,1])
C1273390 (UMLS CUI [5,2])
C0006826 (UMLS CUI [6,1])
C1273390 (UMLS CUI [6,2])
Metastatic malignant neoplasm to brain Requirement Therapeutic procedure | Disease Progression
Item
active brain metastases (requiring treatment or progressing)
boolean
C0220650 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0242656 (UMLS CUI [2])
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