ID

36671

Descripción

A Study of Abemaciclib (LY2835219) in Participants With Stage IV Squamous Non-small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02450539

Link

https://clinicaltrials.gov/show/NCT02450539

Palabras clave

Versiones (1)
  1. 31/5/19 31/5/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

31 de mayo de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Non-Small Cell Lung Cancer Stage IV NCT02450539

Inglés

Eligibility Non-Small Cell Lung Cancer Stage IV NCT02450539

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
confirmed diagnosis of stage iv nsclc.
Descripción

Non-Small Cell Lung Carcinoma TNM clinical staging

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
have progressed during or after platinum-based chemotherapy for advanced disease.
Descripción

Disease Progression | Chemotherapy Platinum-Based Advanced disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C1514162
UMLS CUI [2,3]
C0679246
have not received prior treatment with docetaxel.
Descripción

Docetaxel Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0246415
UMLS CUI [1,2]
C0332197
have availability of adequate formalin-fixed paraffin-embedded (ffpe) tumor derived material.
Descripción

Availability of Tumor tissue sample Formalin-fixed paraffin-embedded

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C0475358
UMLS CUI [1,3]
C2711483
have adequate organ function including hematology, renal, and liver.
Descripción

Organ function | Hematologic function | Renal function | Liver function

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2]
C0221130
UMLS CUI [3]
C0232804
UMLS CUI [4]
C0232741
have good performance score (0-1).
Descripción

Performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1518965
have measureable disease per recist 1.1.
Descripción

Measurable Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1513041
agree to use a reliable medically approved method of birth control.
Descripción

Use of Contraceptive methods

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
have received prior treatment with any cyclin dependent kinase (cdk) 4 and 6 inhibitor or participated in a clinical trial with a cdk 4 and 6 inhibitor and the treatment administered is not known.
Descripción

INK4 Cyclin-Dependent Kinase Inhibitors | Study Subject Participation Status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1564584
UMLS CUI [2]
C2348568
are currently receiving treatment in a clinical trial involving an investigational product or non-approved use of a drug or device.
Descripción

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
have the presence of unstable central nervous system (cns) metastasis.
Descripción

CNS metastases Unstable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0443343
have had major surgery (excluding biopsy) < 28 days of the initial dose of study drug.
Descripción

Major surgery | Exception Biopsy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0005558
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Similar models

Eligibility Non-Small Cell Lung Cancer Stage IV NCT02450539

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma TNM clinical staging
Item
confirmed diagnosis of stage iv nsclc.
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Disease Progression | Chemotherapy Platinum-Based Advanced disease
Item
have progressed during or after platinum-based chemotherapy for advanced disease.
boolean
C0242656 (UMLS CUI [1])
C0392920 (UMLS CUI [2,1])
C1514162 (UMLS CUI [2,2])
C0679246 (UMLS CUI [2,3])
Docetaxel Absent
Item
have not received prior treatment with docetaxel.
boolean
C0246415 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Availability of Tumor tissue sample Formalin-fixed paraffin-embedded
Item
have availability of adequate formalin-fixed paraffin-embedded (ffpe) tumor derived material.
boolean
C0470187 (UMLS CUI [1,1])
C0475358 (UMLS CUI [1,2])
C2711483 (UMLS CUI [1,3])
Organ function | Hematologic function | Renal function | Liver function
Item
have adequate organ function including hematology, renal, and liver.
boolean
C0678852 (UMLS CUI [1])
C0221130 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
C0232741 (UMLS CUI [4])
Performance status
Item
have good performance score (0-1).
boolean
C1518965 (UMLS CUI [1])
Measurable Disease
Item
have measureable disease per recist 1.1.
boolean
C1513041 (UMLS CUI [1])
Use of Contraceptive methods
Item
agree to use a reliable medically approved method of birth control.
boolean
C1524063 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
INK4 Cyclin-Dependent Kinase Inhibitors | Study Subject Participation Status
Item
have received prior treatment with any cyclin dependent kinase (cdk) 4 and 6 inhibitor or participated in a clinical trial with a cdk 4 and 6 inhibitor and the treatment administered is not known.
boolean
C1564584 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
are currently receiving treatment in a clinical trial involving an investigational product or non-approved use of a drug or device.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
CNS metastases Unstable
Item
have the presence of unstable central nervous system (cns) metastasis.
boolean
C0686377 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
Major surgery | Exception Biopsy
Item
have had major surgery (excluding biopsy) < 28 days of the initial dose of study drug.
boolean
C0679637 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0005558 (UMLS CUI [2,2])
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