ID

38409

Descripción

Study Assessing Safety, Pharmacokinetics and Efficacy of CC-223 With Either Erlotinib or Oral Azacitidine in Advanced Non-Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01545947

Link

https://clinicaltrials.gov/show/NCT01545947

Palabras clave

Versiones (1)
  1. 16/10/19 16/10/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

16 de octubre de 2019

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 Carcinoma, Non-Small-Cell Lung NCT01545947

Inglés

Eligibility Carcinoma, Non-Small-Cell Lung NCT01545947

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. men and women, 18 years or older, with histologically or cytologically-confirmed, stage iiib/iv non-small cell lung cancer with tumor progression following at least one prior treatment regimen (either chemotherapy or an epidermal growth factor receptor inhibitor) for advanced disease. there is no restriction on the number of prior treatment regimens allowed.
Descripción

Age | Non-Small Cell Lung Carcinoma TNM clinical staging | Tumor Progression | Prior Therapy Quantity Advanced disease | Chemotherapy | Epidermal growth factor receptor inhibitor

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0007131
UMLS CUI [2,2]
C3258246
UMLS CUI [3]
C0178874
UMLS CUI [4,1]
C1514463
UMLS CUI [4,2]
C1265611
UMLS CUI [4,3]
C0679246
UMLS CUI [5]
C0392920
UMLS CUI [6]
C1443775
2. eastern cooperative oncology group performance score of 0 to 1.
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
3. adequate organ function.
Descripción

Organ function

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0678852
4. adequate contraception (if appropriate).
Descripción

Contraceptive methods

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0700589
5. consent to retrieve archival tumor tissue.
Descripción

Consent Tumor tissue sample

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1511481
UMLS CUI [1,2]
C0475358
6. consent to repeated tumor biopsy (dose expansion phase).
Descripción

Neoplasm Biopsy Repeated

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0005558
UMLS CUI [1,3]
C0205341
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. prior systemic cancer-directed treatments or investigational drugs within 4 weeks or 5 half lives, whichever is shorter except erlotinib which may be continued with intervention in subjects allocated in arm a.
Descripción

Cancer treatment Systemic | Investigational New Drugs | Exception Erlotinib

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205373
UMLS CUI [2]
C0013230
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1135135
2. symptomatic central nervous system metastases.
Descripción

CNS metastases Symptomatic

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0231220
3. acute or chronic pancreatitis.
Descripción

Pancreatitis | Pancreatitis, Chronic

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0030305
UMLS CUI [2]
C0149521
4. persistent diarrhea or malabsorption > grade 2, despite medical management.
Descripción

Diarrhea persistent | Malabsorption CTCAE Grades

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0743188
UMLS CUI [2,1]
C3714745
UMLS CUI [2,2]
C1516728
5. impaired cardiac function or significant cardiac disease.
Descripción

Impaired cardiac function | Heart Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232166
UMLS CUI [2]
C0018799
6. diabetes on active treatment, fasting blood glucose > 126 mg/dl, hba1c > 6.5%.
Descripción

Treatment Diabetes Mellitus | Fasting blood glucose measurement | Hemoglobin A1c measurement

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0011849
UMLS CUI [2]
C0428568
UMLS CUI [3]
C0474680
7. known human immunodeficiency virus, chronic hepatitis b or c infection.
Descripción

HIV Infection | Hepatitis B, Chronic | Hepatitis C, Chronic

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0524909
UMLS CUI [3]
C0524910
8. prior treatment with an investigational dual torc1/torc2, pi3k, or akt inhibitor. prior treatment with rapalogs is allowed.
Descripción

TORC1 TORC2 Inhibitor | PI3K Inhibitor | AKT Inhibitor

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3152111
UMLS CUI [1,2]
C3152112
UMLS CUI [1,3]
C1999216
UMLS CUI [2]
C1519050
UMLS CUI [3,1]
C0812228
UMLS CUI [3,2]
C1999216
9. major surgery < 2 weeks prior to starting study drugs. no specific wash out is required for radiotherapy. subjects must have recovered from any effects of recent therapy that might confound the safety evaluation of study drug.
Descripción

Major surgery | Patient recovered Effects of Therapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2,1]
C1115804
UMLS CUI [2,2]
C1704420
UMLS CUI [2,3]
C0087111
10. pregnant or breastfeeding, inadequate contraception.
Descripción

Pregnancy | Breast Feeding | Contraceptive methods Inadequate

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0700589
UMLS CUI [3,2]
C0205412
11. history of concurrent second malignancies requiring ongoing systemic treatment.
Descripción

Second Cancers Requirement Systemic therapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0751623
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C1515119
Volver a la parte superior de la página

Similar models

Eligibility Carcinoma, Non-Small-Cell Lung NCT01545947

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age | Non-Small Cell Lung Carcinoma TNM clinical staging | Tumor Progression | Prior Therapy Quantity Advanced disease | Chemotherapy | Epidermal growth factor receptor inhibitor
Item
1. men and women, 18 years or older, with histologically or cytologically-confirmed, stage iiib/iv non-small cell lung cancer with tumor progression following at least one prior treatment regimen (either chemotherapy or an epidermal growth factor receptor inhibitor) for advanced disease. there is no restriction on the number of prior treatment regimens allowed.
boolean
C0001779 (UMLS CUI [1])
C0007131 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
C0178874 (UMLS CUI [3])
C1514463 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C0679246 (UMLS CUI [4,3])
C0392920 (UMLS CUI [5])
C1443775 (UMLS CUI [6])
ECOG performance status
Item
2. eastern cooperative oncology group performance score of 0 to 1.
boolean
C1520224 (UMLS CUI [1])
Organ function
Item
3. adequate organ function.
boolean
C0678852 (UMLS CUI [1])
Contraceptive methods
Item
4. adequate contraception (if appropriate).
boolean
C0700589 (UMLS CUI [1])
Consent Tumor tissue sample
Item
5. consent to retrieve archival tumor tissue.
boolean
C1511481 (UMLS CUI [1,1])
C0475358 (UMLS CUI [1,2])
Neoplasm Biopsy Repeated
Item
6. consent to repeated tumor biopsy (dose expansion phase).
boolean
C0027651 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Cancer treatment Systemic | Investigational New Drugs | Exception Erlotinib
Item
1. prior systemic cancer-directed treatments or investigational drugs within 4 weeks or 5 half lives, whichever is shorter except erlotinib which may be continued with intervention in subjects allocated in arm a.
boolean
C0920425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0013230 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C1135135 (UMLS CUI [3,2])
CNS metastases Symptomatic
Item
2. symptomatic central nervous system metastases.
boolean
C0686377 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Pancreatitis | Pancreatitis, Chronic
Item
3. acute or chronic pancreatitis.
boolean
C0030305 (UMLS CUI [1])
C0149521 (UMLS CUI [2])
Diarrhea persistent | Malabsorption CTCAE Grades
Item
4. persistent diarrhea or malabsorption > grade 2, despite medical management.
boolean
C0743188 (UMLS CUI [1])
C3714745 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
Impaired cardiac function | Heart Disease
Item
5. impaired cardiac function or significant cardiac disease.
boolean
C0232166 (UMLS CUI [1])
C0018799 (UMLS CUI [2])
Treatment Diabetes Mellitus | Fasting blood glucose measurement | Hemoglobin A1c measurement
Item
6. diabetes on active treatment, fasting blood glucose > 126 mg/dl, hba1c > 6.5%.
boolean
C0087111 (UMLS CUI [1,1])
C0011849 (UMLS CUI [1,2])
C0428568 (UMLS CUI [2])
C0474680 (UMLS CUI [3])
HIV Infection | Hepatitis B, Chronic | Hepatitis C, Chronic
Item
7. known human immunodeficiency virus, chronic hepatitis b or c infection.
boolean
C0019693 (UMLS CUI [1])
C0524909 (UMLS CUI [2])
C0524910 (UMLS CUI [3])
TORC1 TORC2 Inhibitor | PI3K Inhibitor | AKT Inhibitor
Item
8. prior treatment with an investigational dual torc1/torc2, pi3k, or akt inhibitor. prior treatment with rapalogs is allowed.
boolean
C3152111 (UMLS CUI [1,1])
C3152112 (UMLS CUI [1,2])
C1999216 (UMLS CUI [1,3])
C1519050 (UMLS CUI [2])
C0812228 (UMLS CUI [3,1])
C1999216 (UMLS CUI [3,2])
Major surgery | Patient recovered Effects of Therapy
Item
9. major surgery < 2 weeks prior to starting study drugs. no specific wash out is required for radiotherapy. subjects must have recovered from any effects of recent therapy that might confound the safety evaluation of study drug.
boolean
C0679637 (UMLS CUI [1])
C1115804 (UMLS CUI [2,1])
C1704420 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
Pregnancy | Breast Feeding | Contraceptive methods Inadequate
Item
10. pregnant or breastfeeding, inadequate contraception.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3,1])
C0205412 (UMLS CUI [3,2])
Second Cancers Requirement Systemic therapy
Item
11. history of concurrent second malignancies requiring ongoing systemic treatment.
boolean
C0751623 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C1515119 (UMLS CUI [1,3])
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