ID

30650

Descripción

A Study of PI3-Kinase Inhibitor GDC-0941 in Combination With Paclitaxel, With and Without Bevacizumab or Trastuzumab, in Patients With Locally Recurrent Or Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00960960

Link

https://clinicaltrials.gov/show/NCT00960960

Palabras clave

Versiones (1)
  1. 19/6/18 19/6/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

19 de junio 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 Metastatic Breast Cancer, Locally Advanced Breast Cancer NCT00960960

Inglés

Eligibility Metastatic Breast Cancer, Locally Advanced Breast Cancer NCT00960960

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease
Descripción

Breast adenocarcinoma | Recurrent disease Local | Neoplasm Metastasis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0858252
UMLS CUI [2,1]
C0277556
UMLS CUI [2,2]
C0205276
UMLS CUI [3]
C0027627
adequate organ and bone marrow function as assessed by laboratory tests
Descripción

Organ function | Bone Marrow function

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
evaluable disease or disease measurable per response evaluation criteria in solid tumors (recist)
Descripción

Evaluable Disease | Measurable Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1516986
UMLS CUI [2]
C1513041
agreement to use an effective form of contraception for the duration of the study
Descripción

Contraceptive methods

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0700589
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of grade >/= 3 fasting hyperglycemia
Descripción

Fasting hyperglycaemia CTCAE Grades

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2609269
UMLS CUI [1,2]
C1516728
history of diabetes requiring regular medication
Descripción

Diabetes Mellitus Requirement Pharmaceutical Preparations Regular

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0013227
UMLS CUI [1,4]
C0205272
history of malabsorption syndrome or other condition that would interfere with enteral absorption
Descripción

Malabsorption Syndrome Interferes with Absorption Enteral | Condition Interferes with Absorption Enteral

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0024523
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0237442
UMLS CUI [1,4]
C1304890
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0237442
UMLS CUI [2,4]
C1304890
any condition requiring full-dose anticoagulants, such as warfarin, heparin, or thrombolytic agents
Descripción

Condition Requirement Anticoagulants | Warfarin | Heparin | Thrombolytic Agents

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0003280
UMLS CUI [2]
C0043031
UMLS CUI [3]
C0019134
UMLS CUI [4]
C0016018
prior anti-cancer therapy (e.g., chemotherapy, biologic therapy, or hormonal therapy) within a specified timeframe of the first dose of study treatment
Descripción

Cancer treatment Previous | Chemotherapy | Biological treatment | Hormone Therapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205156
UMLS CUI [2]
C0392920
UMLS CUI [3]
C1531518
UMLS CUI [4]
C0279025
uncontrolled current illness
Descripción

Illness Uncontrolled

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205318
active autoimmune disease requiring the equivalent of >10 mg/day of prednisone
Descripción

Autoimmune Diseases | Requirement Equivalent Prednisone U/day

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0205163
UMLS CUI [2,3]
C0032952
UMLS CUI [2,4]
C0456683
clinically significant history of liver disease, including cirrhosis, current alcohol abuse, or current known active infection with hiv, hepatitis b virus, or hepatitis c virus
Descripción

Liver diseases | Liver Cirrhosis | Alcohol abuse | HIV Infection | Hepatitis B | Hepatitis C

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0023890
UMLS CUI [3]
C0085762
UMLS CUI [4]
C0019693
UMLS CUI [5]
C0019163
UMLS CUI [6]
C0019196
known hiv infection
Descripción

HIV Infection

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019693
new york heart association (nyha) class ii or greater congestive heart failure
Descripción

Congestive heart failure New York Heart Association Classification

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
active ventricular arrhythmia requiring medication
Descripción

Ventricular arrhythmia Requirement Pharmaceutical Preparations

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0085612
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0013227
pregnancy, lactation, or breastfeeding
Descripción

Pregnancy | Lactation | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0022925
UMLS CUI [3]
C0006147
known significant hypersensitivity to study drugs or excipients
Descripción

Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drugs Excipient

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013230
UMLS CUI [2,3]
C0015237
history of arterial thromboembolic disease within 6 months of first study treatment
Descripción

Thromboembolism Arterial

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0040038
UMLS CUI [1,2]
C0221464
no more than two prior chemotherapy regimens for metastatic disease
Descripción

Chemotherapy Regimen Quantity Neoplasm Metastasis

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0027627
no prior taxane therapy for metastatic disease
Descripción

Taxane Neoplasm Metastasis

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0215136
UMLS CUI [1,2]
C0027627
Volver a la parte superior de la página

Similar models

Eligibility Metastatic Breast Cancer, Locally Advanced Breast Cancer NCT00960960

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Breast adenocarcinoma | Recurrent disease Local | Neoplasm Metastasis
Item
confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease
boolean
C0858252 (UMLS CUI [1])
C0277556 (UMLS CUI [2,1])
C0205276 (UMLS CUI [2,2])
C0027627 (UMLS CUI [3])
Organ function | Bone Marrow function
Item
adequate organ and bone marrow function as assessed by laboratory tests
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
Evaluable Disease | Measurable Disease
Item
evaluable disease or disease measurable per response evaluation criteria in solid tumors (recist)
boolean
C1516986 (UMLS CUI [1])
C1513041 (UMLS CUI [2])
Contraceptive methods
Item
agreement to use an effective form of contraception for the duration of the study
boolean
C0700589 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Fasting hyperglycaemia CTCAE Grades
Item
history of grade >/= 3 fasting hyperglycemia
boolean
C2609269 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Diabetes Mellitus Requirement Pharmaceutical Preparations Regular
Item
history of diabetes requiring regular medication
boolean
C0011849 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0205272 (UMLS CUI [1,4])
Malabsorption Syndrome Interferes with Absorption Enteral | Condition Interferes with Absorption Enteral
Item
history of malabsorption syndrome or other condition that would interfere with enteral absorption
boolean
C0024523 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0237442 (UMLS CUI [1,3])
C1304890 (UMLS CUI [1,4])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0237442 (UMLS CUI [2,3])
C1304890 (UMLS CUI [2,4])
Condition Requirement Anticoagulants | Warfarin | Heparin | Thrombolytic Agents
Item
any condition requiring full-dose anticoagulants, such as warfarin, heparin, or thrombolytic agents
boolean
C0348080 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0003280 (UMLS CUI [1,3])
C0043031 (UMLS CUI [2])
C0019134 (UMLS CUI [3])
C0016018 (UMLS CUI [4])
Cancer treatment Previous | Chemotherapy | Biological treatment | Hormone Therapy
Item
prior anti-cancer therapy (e.g., chemotherapy, biologic therapy, or hormonal therapy) within a specified timeframe of the first dose of study treatment
boolean
C0920425 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2])
C1531518 (UMLS CUI [3])
C0279025 (UMLS CUI [4])
Illness Uncontrolled
Item
uncontrolled current illness
boolean
C0221423 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Autoimmune Diseases | Requirement Equivalent Prednisone U/day
Item
active autoimmune disease requiring the equivalent of >10 mg/day of prednisone
boolean
C0004364 (UMLS CUI [1])
C1514873 (UMLS CUI [2,1])
C0205163 (UMLS CUI [2,2])
C0032952 (UMLS CUI [2,3])
C0456683 (UMLS CUI [2,4])
Liver diseases | Liver Cirrhosis | Alcohol abuse | HIV Infection | Hepatitis B | Hepatitis C
Item
clinically significant history of liver disease, including cirrhosis, current alcohol abuse, or current known active infection with hiv, hepatitis b virus, or hepatitis c virus
boolean
C0023895 (UMLS CUI [1])
C0023890 (UMLS CUI [2])
C0085762 (UMLS CUI [3])
C0019693 (UMLS CUI [4])
C0019163 (UMLS CUI [5])
C0019196 (UMLS CUI [6])
HIV Infection
Item
known hiv infection
boolean
C0019693 (UMLS CUI [1])
Congestive heart failure New York Heart Association Classification
Item
new york heart association (nyha) class ii or greater congestive heart failure
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Ventricular arrhythmia Requirement Pharmaceutical Preparations
Item
active ventricular arrhythmia requiring medication
boolean
C0085612 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
Pregnancy | Lactation | Breast Feeding
Item
pregnancy, lactation, or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0022925 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drugs Excipient
Item
known significant hypersensitivity to study drugs or excipients
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
Thromboembolism Arterial
Item
history of arterial thromboembolic disease within 6 months of first study treatment
boolean
C0040038 (UMLS CUI [1,1])
C0221464 (UMLS CUI [1,2])
Chemotherapy Regimen Quantity Neoplasm Metastasis
Item
no more than two prior chemotherapy regimens for metastatic disease
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
Taxane Neoplasm Metastasis
Item
no prior taxane therapy for metastatic disease
boolean
C0215136 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
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