ID

44258

Descrição

A Study of Advanced or Metastatic Non-small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00988858

Link

https://clinicaltrials.gov/show/NCT00988858

Palavras-chave

Versões (2)
  1. 15/07/2018 15/07/2018 -
  2. 20/09/2021 20/09/2021 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

20 de setembro de 2021

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Non Small Cell Lung Cancer NCT00988858

Inglês

Eligibility Non Small Cell Lung Cancer NCT00988858

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
must agree to have a tumor biopsy at screening
Descrição

Agreement Tumor Biopsy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0680240
UMLS CUI [1,2]
C0027651
UMLS CUI [1,3]
C0005558
must have a diagnosis of advanced or metastatic non-squamous non-small cell lung cancer that has progressed after certain prior treatment
Descrição

Non-Squamous Non-Small Cell Lung Carcinoma Advanced | Metastatic Non-Squamous Non-Small Cell Lung Carcinoma | Disease Progression Post Prior Therapy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C4324656
UMLS CUI [1,2]
C0205179
UMLS CUI [2]
C4288755
UMLS CUI [3,1]
C0242656
UMLS CUI [3,2]
C0687676
UMLS CUI [3,3]
C1514463
must be available for the duration of the study and willing to follow the study procedures
Descrição

Patient Available Study duration | Protocol Compliance

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0470187
UMLS CUI [1,3]
C0489652
UMLS CUI [2]
C0525058
if participant is a woman that is capable of having children, must have a negative pregnancy test within 7 days of taking first dose of study drug
Descrição

Childbearing Potential Pregnancy test negative

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
must have discontinued radiation therapy at least 4 weeks before entering this study
Descrição

Therapeutic radiology procedure Discontinued

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C1444662
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
must not have taken an unapproved drug as treatment for any indication within the last 28 days before starting study treatment.
Descrição

Drugs, Non-Prescription

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0013231
must not be pregnant or lactating, are considering becoming pregnant, or are considering fathering a child. males and females with reproductive potential must agree to use medically approved contraceptive precautions during the trial until the patient's physician considers it safe to become pregnant or father a child.
Descrição

Pregnancy | Breast Feeding | Pregnancy considering | Reproduction considering | Females & males of reproductive potential Contraceptive methods

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0032961
UMLS CUI [3,2]
C0750591
UMLS CUI [4,1]
C0035150
UMLS CUI [4,2]
C0750591
UMLS CUI [5,1]
C4034483
UMLS CUI [5,2]
C0700589
must not have known positive test in human immunodeficiency virus (hiv), hepatitis b surface antigen (hbsag), or hepatitis c antibodies (hcab).
Descrição

HIV Seropositivity | Hepatitis B surface antigen positive | Hepatitis C antibody test positive

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0149709
UMLS CUI [3]
C1277805
must not have previously participated in a study involving ly2603618
Descrição

Study Subject Participation Status | Involvement with LY2603618

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C1314939
UMLS CUI [2,2]
C2825835
must not have previously taken pemetrexed for cancer
Descrição

Pemetrexed Relationship Cancer treatment

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0210657
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0920425
must not have a known allergy to ly2603618 or pemetrexed
Descrição

Hypersensitivity LY2603618 | Hypersensitivity Pemetrexed

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2825835
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0210657
must not currently have an infection that may affect patient's ability to tolerate the therapy
Descrição

Communicable Disease Affecting Therapeutic aspects

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0039798
must not have a serious medical condition or disorder that would make it unsafe for you to participate in the study such as uncontrolled diabetes or chest pain due to heart disease
Descrição

Medical condition Serious Study Subject Participation Status At risk | Disease Serious Study Subject Participation Status At risk | Diabetic - poor control | Chest Pain Due to Heart Disease

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C2348568
UMLS CUI [1,4]
C1444641
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C2348568
UMLS CUI [2,4]
C1444641
UMLS CUI [3]
C0421258
UMLS CUI [4,1]
C0008031
UMLS CUI [4,2]
C0678226
UMLS CUI [4,3]
C0018799
if taking certain medications called non-steroidal anti-inflammatory drugs (nsaids), such as ibuprofen, must be able to stop taking these medications according to certain guidelines
Descrição

Non-Steroidal Anti-Inflammatory Agents Discontinue Able | Ibuprofen Discontinue Able

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0003211
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C0085732
UMLS CUI [2,1]
C0020740
UMLS CUI [2,2]
C1444662
UMLS CUI [2,3]
C0085732
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Similar models

Eligibility Non Small Cell Lung Cancer NCT00988858

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Agreement Tumor Biopsy
Item
must agree to have a tumor biopsy at screening
boolean
C0680240 (UMLS CUI [1,1])
C0027651 (UMLS CUI [1,2])
C0005558 (UMLS CUI [1,3])
Non-Squamous Non-Small Cell Lung Carcinoma Advanced | Metastatic Non-Squamous Non-Small Cell Lung Carcinoma | Disease Progression Post Prior Therapy
Item
must have a diagnosis of advanced or metastatic non-squamous non-small cell lung cancer that has progressed after certain prior treatment
boolean
C4324656 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C4288755 (UMLS CUI [2])
C0242656 (UMLS CUI [3,1])
C0687676 (UMLS CUI [3,2])
C1514463 (UMLS CUI [3,3])
Patient Available Study duration | Protocol Compliance
Item
must be available for the duration of the study and willing to follow the study procedures
boolean
C0030705 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C0489652 (UMLS CUI [1,3])
C0525058 (UMLS CUI [2])
Childbearing Potential Pregnancy test negative
Item
if participant is a woman that is capable of having children, must have a negative pregnancy test within 7 days of taking first dose of study drug
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Therapeutic radiology procedure Discontinued
Item
must have discontinued radiation therapy at least 4 weeks before entering this study
boolean
C1522449 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Drugs, Non-Prescription
Item
must not have taken an unapproved drug as treatment for any indication within the last 28 days before starting study treatment.
boolean
C0013231 (UMLS CUI [1])
Pregnancy | Breast Feeding | Pregnancy considering | Reproduction considering | Females & males of reproductive potential Contraceptive methods
Item
must not be pregnant or lactating, are considering becoming pregnant, or are considering fathering a child. males and females with reproductive potential must agree to use medically approved contraceptive precautions during the trial until the patient's physician considers it safe to become pregnant or father a child.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C0750591 (UMLS CUI [3,2])
C0035150 (UMLS CUI [4,1])
C0750591 (UMLS CUI [4,2])
C4034483 (UMLS CUI [5,1])
C0700589 (UMLS CUI [5,2])
HIV Seropositivity | Hepatitis B surface antigen positive | Hepatitis C antibody test positive
Item
must not have known positive test in human immunodeficiency virus (hiv), hepatitis b surface antigen (hbsag), or hepatitis c antibodies (hcab).
boolean
C0019699 (UMLS CUI [1])
C0149709 (UMLS CUI [2])
C1277805 (UMLS CUI [3])
Study Subject Participation Status | Involvement with LY2603618
Item
must not have previously participated in a study involving ly2603618
boolean
C2348568 (UMLS CUI [1])
C1314939 (UMLS CUI [2,1])
C2825835 (UMLS CUI [2,2])
Pemetrexed Relationship Cancer treatment
Item
must not have previously taken pemetrexed for cancer
boolean
C0210657 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0920425 (UMLS CUI [1,3])
Hypersensitivity LY2603618 | Hypersensitivity Pemetrexed
Item
must not have a known allergy to ly2603618 or pemetrexed
boolean
C0020517 (UMLS CUI [1,1])
C2825835 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0210657 (UMLS CUI [2,2])
Communicable Disease Affecting Therapeutic aspects
Item
must not currently have an infection that may affect patient's ability to tolerate the therapy
boolean
C0009450 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0039798 (UMLS CUI [1,3])
Medical condition Serious Study Subject Participation Status At risk | Disease Serious Study Subject Participation Status At risk | Diabetic - poor control | Chest Pain Due to Heart Disease
Item
must not have a serious medical condition or disorder that would make it unsafe for you to participate in the study such as uncontrolled diabetes or chest pain due to heart disease
boolean
C3843040 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C1444641 (UMLS CUI [1,4])
C0012634 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C1444641 (UMLS CUI [2,4])
C0421258 (UMLS CUI [3])
C0008031 (UMLS CUI [4,1])
C0678226 (UMLS CUI [4,2])
C0018799 (UMLS CUI [4,3])
Non-Steroidal Anti-Inflammatory Agents Discontinue Able | Ibuprofen Discontinue Able
Item
if taking certain medications called non-steroidal anti-inflammatory drugs (nsaids), such as ibuprofen, must be able to stop taking these medications according to certain guidelines
boolean
C0003211 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
C0020740 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0085732 (UMLS CUI [2,3])
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