ID

31209

Description

E7080 in Combination With Carboplatin and Paclitaxel in Patients With Non-small Cell Lung Cancer (NSCLC); ODM derived from: https://clinicaltrials.gov/show/NCT00832819

Link

https://clinicaltrials.gov/show/NCT00832819

Keywords

Versions (1)
  1. 7/29/18 7/29/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 29, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Non-small-cell Lung Cancer NCT00832819

English

Eligibility Non-small-cell Lung Cancer NCT00832819

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. subjects with a histologically or cytologically confirmed diagnosis of non-small cell lung cancer (nsclc).
Description

Non-Small Cell Lung Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0007131
2. locally advanced and/or metastatic non-small cell lung cancer (nsclc) (stage iiib/iv).
Description

Non-Small Cell Lung Carcinoma Advanced Locally TNM clinical staging | Non-small cell lung cancer metastatic TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C1517927
UMLS CUI [1,4]
C3258246
UMLS CUI [2,1]
C0278987
UMLS CUI [2,2]
C3258246
3. subjects with at least one measurable tumor lesion by response evaluation criteria in solid tumors (recist).
Description

Measurable lesion Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
4. subjects with performance status (ps) 0-1.
Description

Performance status

Data type

boolean

Alias
UMLS CUI [1]
C1518965
5. subjects with adequate organ function.
Description

Organ function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. subjects who have ever received the following therapy for non-small cell lung cancer (nsclc):
Description

Therapeutic procedure Specified Non-Small Cell Lung Carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0205369
UMLS CUI [1,3]
C0007131
1. chemotherapy
Description

Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0392920
2. biological or immunotherapies
Description

Biological treatment | Immunotherapy

Data type

boolean

Alias
UMLS CUI [1]
C1531518
UMLS CUI [2]
C0021083
3. surgery for primary focus
Description

Operative Surgical Procedures Focus Primary

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0205234
UMLS CUI [1,3]
C0205225
4. the radiation therapy for primary focus
Description

Therapeutic radiology procedure Focus Primary

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0205234
UMLS CUI [1,3]
C0205225
2. subjects with the severe complications or disease history.
Description

Severe medical complication | Disease Severe

Data type

boolean

Alias
UMLS CUI [1]
C3495031
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0205082
3. subjects with brain metastasis accompanying clinical symptoms or requiring treatment.
Description

Metastatic malignant neoplasm to brain Associated with Symptoms | Metastatic malignant neoplasm to brain Treatment required for

Data type

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C1457887
UMLS CUI [2,1]
C0220650
UMLS CUI [2,2]
C0332121
4. subjects with simultaneous or metachronous cancers.
Description

Cancer Other | Metachronous Malignant Neoplasm

Data type

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2]
C1334703
5. subjects who cannot take oral medication.
Description

Lacking Able to swallow Oral medication

Data type

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C2712086
UMLS CUI [1,3]
C0175795
6. subjects who are using drugs that strongly inhibit or induce cytochrome p450 (cyp) 3a4.
Description

CYP3A4 Inhibitor | CYP3A4 Inducer

Data type

boolean

Alias
UMLS CUI [1]
C3830624
UMLS CUI [2]
C3830625
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Similar models

Eligibility Non-small-cell Lung Cancer NCT00832819

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma
Item
1. subjects with a histologically or cytologically confirmed diagnosis of non-small cell lung cancer (nsclc).
boolean
C0007131 (UMLS CUI [1])
Non-Small Cell Lung Carcinoma Advanced Locally TNM clinical staging | Non-small cell lung cancer metastatic TNM clinical staging
Item
2. locally advanced and/or metastatic non-small cell lung cancer (nsclc) (stage iiib/iv).
boolean
C0007131 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C1517927 (UMLS CUI [1,3])
C3258246 (UMLS CUI [1,4])
C0278987 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
Measurable lesion Quantity
Item
3. subjects with at least one measurable tumor lesion by response evaluation criteria in solid tumors (recist).
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Performance status
Item
4. subjects with performance status (ps) 0-1.
boolean
C1518965 (UMLS CUI [1])
Organ function
Item
5. subjects with adequate organ function.
boolean
C0678852 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Therapeutic procedure Specified Non-Small Cell Lung Carcinoma
Item
1. subjects who have ever received the following therapy for non-small cell lung cancer (nsclc):
boolean
C0087111 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C0007131 (UMLS CUI [1,3])
Chemotherapy
Item
1. chemotherapy
boolean
C0392920 (UMLS CUI [1])
Biological treatment | Immunotherapy
Item
2. biological or immunotherapies
boolean
C1531518 (UMLS CUI [1])
C0021083 (UMLS CUI [2])
Operative Surgical Procedures Focus Primary
Item
3. surgery for primary focus
boolean
C0543467 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
Therapeutic radiology procedure Focus Primary
Item
4. the radiation therapy for primary focus
boolean
C1522449 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
Severe medical complication | Disease Severe
Item
2. subjects with the severe complications or disease history.
boolean
C3495031 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Metastatic malignant neoplasm to brain Associated with Symptoms | Metastatic malignant neoplasm to brain Treatment required for
Item
3. subjects with brain metastasis accompanying clinical symptoms or requiring treatment.
boolean
C0220650 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0220650 (UMLS CUI [2,1])
C0332121 (UMLS CUI [2,2])
Cancer Other | Metachronous Malignant Neoplasm
Item
4. subjects with simultaneous or metachronous cancers.
boolean
C1707251 (UMLS CUI [1])
C1334703 (UMLS CUI [2])
Lacking Able to swallow Oral medication
Item
5. subjects who cannot take oral medication.
boolean
C0332268 (UMLS CUI [1,1])
C2712086 (UMLS CUI [1,2])
C0175795 (UMLS CUI [1,3])
CYP3A4 Inhibitor | CYP3A4 Inducer
Item
6. subjects who are using drugs that strongly inhibit or induce cytochrome p450 (cyp) 3a4.
boolean
C3830624 (UMLS CUI [1])
C3830625 (UMLS CUI [2])
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