ID

31111

Descripción

A Phase 1b/2 Study of AMG 655 in Combination With Paclitaxel and Carboplatin for the First-Line Treatment of Advanced Non-Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00534027

Link

https://clinicaltrials.gov/show/NCT00534027

Palabras clave

Versiones (1)
  1. 20/7/18 20/7/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

20 de julio de 2018

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Eligibility Non-Small Cell Lung Cancer NCT00534027

Inglés

Eligibility Non-Small Cell Lung Cancer NCT00534027

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
disease related
Descripción

Disease Related

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0439849
histologically or cytologically confirmed non-small cell lung cancer.
Descripción

Non-Small Cell Lung Carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0007131
subjects must have advanced non-small cell lung cancer defined as stage iiib with malignant pleural effusion or stage iv or recurrent disease.
Descripción

Non-Small Cell Lung Carcinoma Advanced TNM clinical staging | Pleural Effusion, Malignant | Recurrent disease

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C3258246
UMLS CUI [2]
C0080032
UMLS CUI [3]
C0277556
planning to receive up to 6 cycles of chemotherapy
Descripción

Chemotherapy cycle Quantity Planned

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1302181
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C1301732
eastern cooperative oncology group (ecog) score of 0 or 1 demographic
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
men or women > 18 years of age ethical
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
adequate hematological, renal, hepatic and coagulation function general
Descripción

Hematologic function | Renal function | Liver function | Coagulation function analysis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
UMLS CUI [4]
C3516400
plan to begin protocol specific therapy < 7 days after enrollment/randomization
Descripción

Therapeutic procedure Study Protocol Specific

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2348563
UMLS CUI [1,3]
C0205369
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
disease related
Descripción

Disease Related

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0439849
untreated or symptomatic central nervous system metastases. subjects with a history of brain metastases are eligible if definitive therapy has been administered (surgery and/or radiation therapy), there is no planned treatment for brain metastasis and the subject is clinically stable and off corticosteroids for at least 14 days before enrollment/randomization.
Descripción

CNS metastases untreated | CNS metastases Symptomatic | Metastatic malignant neoplasm to brain Eligible | Relationship Definitive Treatment | Relationship Operative Surgical Procedures | Relationship Therapeutic radiology procedure | Adrenal Cortex Hormones Discontinued

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C0686377
UMLS CUI [2,2]
C0231220
UMLS CUI [3,1]
C0220650
UMLS CUI [3,2]
C1548635
UMLS CUI [4,1]
C0439849
UMLS CUI [4,2]
C2986592
UMLS CUI [5,1]
C0439849
UMLS CUI [5,2]
C0543467
UMLS CUI [6,1]
C0439849
UMLS CUI [6,2]
C1522449
UMLS CUI [7,1]
C0001617
UMLS CUI [7,2]
C1444662
prior chemotherapy as follows:
Descripción

Prior Chemotherapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1514457
any prior chemotherapy for advanced non-small cell lung cancer
Descripción

Prior Chemotherapy Non-Small Cell Lung Carcinoma Advanced

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0007131
UMLS CUI [1,3]
C0205179
any prior adjuvant chemotherapy for non-small cell lung cancer < 52 weeks prior to enrollment/randomization. adjuvant chemotherapy completed > 52 weeks prior to randomization is permitted.
Descripción

Adjuvant Chemotherapy Non-Small Cell Lung Carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0085533
UMLS CUI [1,2]
C0007131
UMLS CUI [2,1]
C0085533
UMLS CUI [2,2]
C0007131
UMLS CUI [2,3]
C0205197
UMLS CUI [2,4]
C0683607
any prior chemoradiation.
Descripción

Chemoradiotherapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0436307
central (chest) radiation therapy < 28 days prior to randomization, radiation therapy for peripheral lesions < 14 days prior to enrollment/randomization
Descripción

Radiotherapy to thorax | Radiotherapy to lesion of peripheral nerve

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4038705
UMLS CUI [2]
C0394630
other abnormal medical conditions
Descripción

Other medical condition Abnormal

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205161
documented myocardial infarction or unstable/uncontrolled cardiac condition
Descripción

Myocardial Infarction | Condition cardiac Unstable | Condition cardiac Uncontrolled

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0018787
UMLS CUI [2,3]
C0443343
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C0018787
UMLS CUI [3,3]
C0205318
history of arterial thrombosis, pulmonary embolus, deep vein thrombosis or hemorrhagic disorders
Descripción

Arterial thrombosis | Pulmonary Embolism | Deep Vein Thrombosis | Hemorrhagic Disorders

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0151942
UMLS CUI [2]
C0034065
UMLS CUI [3]
C0149871
UMLS CUI [4]
C0019087
major surgical procedure < 30 days prior to enrollment/randomization or not yet recovered from prior major surgery, minor surgical procedure < 7 days prior to enrollment/randomization or not yet recovered from prior minor surgery
Descripción

Major surgery | Major surgery Previous Recovery Lacking | Minor Surgical Procedures | Minor Surgical Procedures Previous Recovery Lacking

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2,1]
C0679637
UMLS CUI [2,2]
C0205156
UMLS CUI [2,3]
C2004454
UMLS CUI [2,4]
C0332268
UMLS CUI [3]
C0038904
UMLS CUI [4,1]
C0038904
UMLS CUI [4,2]
C0205156
UMLS CUI [4,3]
C2004454
UMLS CUI [4,4]
C0332268
Volver a la parte superior de la página

Similar models

Eligibility Non-Small Cell Lung Cancer NCT00534027

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Disease Related
Item
disease related
boolean
C0012634 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
Non-Small Cell Lung Carcinoma
Item
histologically or cytologically confirmed non-small cell lung cancer.
boolean
C0007131 (UMLS CUI [1])
Non-Small Cell Lung Carcinoma Advanced TNM clinical staging | Pleural Effusion, Malignant | Recurrent disease
Item
subjects must have advanced non-small cell lung cancer defined as stage iiib with malignant pleural effusion or stage iv or recurrent disease.
boolean
C0007131 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
C0080032 (UMLS CUI [2])
C0277556 (UMLS CUI [3])
Chemotherapy cycle Quantity Planned
Item
planning to receive up to 6 cycles of chemotherapy
boolean
C1302181 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
ECOG performance status
Item
eastern cooperative oncology group (ecog) score of 0 or 1 demographic
boolean
C1520224 (UMLS CUI [1])
Age
Item
men or women > 18 years of age ethical
boolean
C0001779 (UMLS CUI [1])
Hematologic function | Renal function | Liver function | Coagulation function analysis
Item
adequate hematological, renal, hepatic and coagulation function general
boolean
C0221130 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
C3516400 (UMLS CUI [4])
Therapeutic procedure Study Protocol Specific
Item
plan to begin protocol specific therapy < 7 days after enrollment/randomization
boolean
C0087111 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Disease Related
Item
disease related
boolean
C0012634 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
CNS metastases untreated | CNS metastases Symptomatic | Metastatic malignant neoplasm to brain Eligible | Relationship Definitive Treatment | Relationship Operative Surgical Procedures | Relationship Therapeutic radiology procedure | Adrenal Cortex Hormones Discontinued
Item
untreated or symptomatic central nervous system metastases. subjects with a history of brain metastases are eligible if definitive therapy has been administered (surgery and/or radiation therapy), there is no planned treatment for brain metastasis and the subject is clinically stable and off corticosteroids for at least 14 days before enrollment/randomization.
boolean
C0686377 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0686377 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0220650 (UMLS CUI [3,1])
C1548635 (UMLS CUI [3,2])
C0439849 (UMLS CUI [4,1])
C2986592 (UMLS CUI [4,2])
C0439849 (UMLS CUI [5,1])
C0543467 (UMLS CUI [5,2])
C0439849 (UMLS CUI [6,1])
C1522449 (UMLS CUI [6,2])
C0001617 (UMLS CUI [7,1])
C1444662 (UMLS CUI [7,2])
Prior Chemotherapy
Item
prior chemotherapy as follows:
boolean
C1514457 (UMLS CUI [1])
Prior Chemotherapy Non-Small Cell Lung Carcinoma Advanced
Item
any prior chemotherapy for advanced non-small cell lung cancer
boolean
C1514457 (UMLS CUI [1,1])
C0007131 (UMLS CUI [1,2])
C0205179 (UMLS CUI [1,3])
Adjuvant Chemotherapy Non-Small Cell Lung Carcinoma
Item
any prior adjuvant chemotherapy for non-small cell lung cancer < 52 weeks prior to enrollment/randomization. adjuvant chemotherapy completed > 52 weeks prior to randomization is permitted.
boolean
C0085533 (UMLS CUI [1,1])
C0007131 (UMLS CUI [1,2])
C0085533 (UMLS CUI [2,1])
C0007131 (UMLS CUI [2,2])
C0205197 (UMLS CUI [2,3])
C0683607 (UMLS CUI [2,4])
Chemoradiotherapy
Item
any prior chemoradiation.
boolean
C0436307 (UMLS CUI [1])
Radiotherapy to thorax | Radiotherapy to lesion of peripheral nerve
Item
central (chest) radiation therapy < 28 days prior to randomization, radiation therapy for peripheral lesions < 14 days prior to enrollment/randomization
boolean
C4038705 (UMLS CUI [1])
C0394630 (UMLS CUI [2])
Other medical condition Abnormal
Item
other abnormal medical conditions
boolean
C3843040 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
Myocardial Infarction | Condition cardiac Unstable | Condition cardiac Uncontrolled
Item
documented myocardial infarction or unstable/uncontrolled cardiac condition
boolean
C0027051 (UMLS CUI [1])
C0348080 (UMLS CUI [2,1])
C0018787 (UMLS CUI [2,2])
C0443343 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C0018787 (UMLS CUI [3,2])
C0205318 (UMLS CUI [3,3])
Arterial thrombosis | Pulmonary Embolism | Deep Vein Thrombosis | Hemorrhagic Disorders
Item
history of arterial thrombosis, pulmonary embolus, deep vein thrombosis or hemorrhagic disorders
boolean
C0151942 (UMLS CUI [1])
C0034065 (UMLS CUI [2])
C0149871 (UMLS CUI [3])
C0019087 (UMLS CUI [4])
Major surgery | Major surgery Previous Recovery Lacking | Minor Surgical Procedures | Minor Surgical Procedures Previous Recovery Lacking
Item
major surgical procedure < 30 days prior to enrollment/randomization or not yet recovered from prior major surgery, minor surgical procedure < 7 days prior to enrollment/randomization or not yet recovered from prior minor surgery
boolean
C0679637 (UMLS CUI [1])
C0679637 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C2004454 (UMLS CUI [2,3])
C0332268 (UMLS CUI [2,4])
C0038904 (UMLS CUI [3])
C0038904 (UMLS CUI [4,1])
C0205156 (UMLS CUI [4,2])
C2004454 (UMLS CUI [4,3])
C0332268 (UMLS CUI [4,4])
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial