ID

27370

Descrição

Phase 1/2 Study of Vascular Disrupting Agent NPI-2358 + Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00630110

Link

https://clinicaltrials.gov/show/NCT00630110

Palavras-chave

Versões (1)
  1. 09/11/2017 09/11/2017 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

9 de novembro de 2017

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Cancer NCT00630110

Inglês

Eligibility Cancer NCT00630110

1 Formulários  
  1. StudyEvent: Eligibility
    1. Eligibility Cancer NCT00630110
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
male and females ≥ 18 years of age
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance status ≤ 1
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
pathologically or histologically confirmed advanced non-small cell lung cancer (unresectable stage iiib or iv) that has progressed after treatment with at least one chemotherapy regimen; measurable disease is not required for enrollment into this trial
Descrição

Non-Small Cell Lung Carcinoma Advanced | Non-Small Cell Lung Carcinoma unresectable TNM clinical staging | Chemotherapy Regimen Quantity | Disease Progression

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0205179
UMLS CUI [2,1]
C0007131
UMLS CUI [2,2]
C1519810
UMLS CUI [2,3]
C3258246
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C1265611
UMLS CUI [4]
C0242656
all adverse events of any prior chemotherapy, surgery, or radiotherapy, must have resolved to grade ≤ 2
Descrição

Adverse event resolved CTCAE Grades | Prior Chemotherapy | Prior surgery | Prior radiation therapy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1514893
UMLS CUI [1,3]
C1516728
UMLS CUI [2]
C1514457
UMLS CUI [3]
C0455610
UMLS CUI [4]
C0279134
signed informed consent
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
administration of certain chemotherapy, biological, immunotherapy, radiation therapy, surgery or investigational agent within specified time frames
Descrição

Chemotherapy | Biological treatment | Immunotherapy | Therapeutic radiology procedure | Operative Surgical Procedures | Investigational New Drugs

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1531518
UMLS CUI [3]
C0021083
UMLS CUI [4]
C1522449
UMLS CUI [5]
C0543467
UMLS CUI [6]
C0013230
significant cardiac history
Descrição

Heart Diseases

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0018799
prior treatment with tumor vascular disruptive agents
Descrição

Vascular-Disruption Therapy Tumor

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1883526
UMLS CUI [1,2]
C0027651
seizure disorder
Descrição

Epilepsy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0014544
brain metastases
Descrição

Metastatic malignant neoplasm to brain

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0220650
active uncontrolled bacterial, viral, or fungal infection, requiring systemic therapy
Descrição

Bacterial Infections Uncontrolled | Virus Diseases Uncontrolled | Mycoses Uncontrolled | Systemic therapy Patient need for

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0004623
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0042769
UMLS CUI [2,2]
C0205318
UMLS CUI [3,1]
C0026946
UMLS CUI [3,2]
C0205318
UMLS CUI [4,1]
C1515119
UMLS CUI [4,2]
C0686904
known infection with human immunodeficiency virus (hiv), or active hepatitis a, b, or c
Descrição

HIV Infection | Hepatitis A | Hepatitis B | Hepatitis C

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0019159
UMLS CUI [3]
C0019163
UMLS CUI [4]
C0019196
patients with a prior hypersensitivity reaction to product components
Descrição

Hypersensitivity Pharmaceutical Preparations Component

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C1705248
pregnant or breast-feeding women.
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
concurrent, active second malignancy for which the patient is receiving therapy, excluding basal cell carcinoma of the skin or carcinoma in situ of the cervix
Descrição

Therapeutic procedure Second Cancer | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0751623
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
unwilling or unable to comply with procedures required in this protocol
Descrição

Protocol Compliance Unwilling | Protocol Compliance Unable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C1299582
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Similar models

Eligibility Cancer NCT00630110

1 Formulários
  1. StudyEvent: Eligibility
    1. Eligibility Cancer NCT00630110
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male and females ≥ 18 years of age
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status ≤ 1
boolean
C1520224 (UMLS CUI [1])
Non-Small Cell Lung Carcinoma Advanced | Non-Small Cell Lung Carcinoma unresectable TNM clinical staging | Chemotherapy Regimen Quantity | Disease Progression
Item
pathologically or histologically confirmed advanced non-small cell lung cancer (unresectable stage iiib or iv) that has progressed after treatment with at least one chemotherapy regimen; measurable disease is not required for enrollment into this trial
boolean
C0007131 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0007131 (UMLS CUI [2,1])
C1519810 (UMLS CUI [2,2])
C3258246 (UMLS CUI [2,3])
C0392920 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0242656 (UMLS CUI [4])
Adverse event resolved CTCAE Grades | Prior Chemotherapy | Prior surgery | Prior radiation therapy
Item
all adverse events of any prior chemotherapy, surgery, or radiotherapy, must have resolved to grade ≤ 2
boolean
C0877248 (UMLS CUI [1,1])
C1514893 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
C1514457 (UMLS CUI [2])
C0455610 (UMLS CUI [3])
C0279134 (UMLS CUI [4])
Informed Consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Chemotherapy | Biological treatment | Immunotherapy | Therapeutic radiology procedure | Operative Surgical Procedures | Investigational New Drugs
Item
administration of certain chemotherapy, biological, immunotherapy, radiation therapy, surgery or investigational agent within specified time frames
boolean
C0392920 (UMLS CUI [1])
C1531518 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
C1522449 (UMLS CUI [4])
C0543467 (UMLS CUI [5])
C0013230 (UMLS CUI [6])
Heart Diseases
Item
significant cardiac history
boolean
C0018799 (UMLS CUI [1])
Vascular-Disruption Therapy Tumor
Item
prior treatment with tumor vascular disruptive agents
boolean
C1883526 (UMLS CUI [1,1])
C0027651 (UMLS CUI [1,2])
Epilepsy
Item
seizure disorder
boolean
C0014544 (UMLS CUI [1])
Metastatic malignant neoplasm to brain
Item
brain metastases
boolean
C0220650 (UMLS CUI [1])
Bacterial Infections Uncontrolled | Virus Diseases Uncontrolled | Mycoses Uncontrolled | Systemic therapy Patient need for
Item
active uncontrolled bacterial, viral, or fungal infection, requiring systemic therapy
boolean
C0004623 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0042769 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0026946 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C1515119 (UMLS CUI [4,1])
C0686904 (UMLS CUI [4,2])
HIV Infection | Hepatitis A | Hepatitis B | Hepatitis C
Item
known infection with human immunodeficiency virus (hiv), or active hepatitis a, b, or c
boolean
C0019693 (UMLS CUI [1])
C0019159 (UMLS CUI [2])
C0019163 (UMLS CUI [3])
C0019196 (UMLS CUI [4])
Hypersensitivity Pharmaceutical Preparations Component
Item
patients with a prior hypersensitivity reaction to product components
boolean
C0020517 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C1705248 (UMLS CUI [1,3])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Therapeutic procedure Second Cancer | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix
Item
concurrent, active second malignancy for which the patient is receiving therapy, excluding basal cell carcinoma of the skin or carcinoma in situ of the cervix
boolean
C0087111 (UMLS CUI [1,1])
C0751623 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
Protocol Compliance Unwilling | Protocol Compliance Unable
Item
unwilling or unable to comply with procedures required in this protocol
boolean
C0525058 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
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