ID

38409

Descrição

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

Palavras-chave

Versões (1)
  1. 16/10/2019 16/10/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

16 de outubro de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Carcinoma, Non-Small-Cell Lung NCT01545947

Inglês

Eligibility Carcinoma, Non-Small-Cell Lung NCT01545947

1 Formulários  
Inclusion Criteria
Descrição

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.
Descrição

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

Tipo de dados

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.
Descrição

ECOG performance status

Tipo de dados

boolean

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

Organ function

Tipo de dados

boolean

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

Contraceptive methods

Tipo de dados

boolean

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

Consent Tumor tissue sample

Tipo de dados

boolean

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

Neoplasm Biopsy Repeated

Tipo de dados

boolean

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

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.
Descrição

Cancer treatment Systemic | Investigational New Drugs | Exception Erlotinib

Tipo de dados

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.
Descrição

CNS metastases Symptomatic

Tipo de dados

boolean

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

Pancreatitis | Pancreatitis, Chronic

Tipo de dados

boolean

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

Diarrhea persistent | Malabsorption CTCAE Grades

Tipo de dados

boolean

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

Impaired cardiac function | Heart Disease

Tipo de dados

boolean

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

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

Tipo de dados

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.
Descrição

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

Tipo de dados

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.
Descrição

TORC1 TORC2 Inhibitor | PI3K Inhibitor | AKT Inhibitor

Tipo de dados

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.
Descrição

Major surgery | Patient recovered Effects of Therapy

Tipo de dados

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.
Descrição

Pregnancy | Breast Feeding | Contraceptive methods Inadequate

Tipo de dados

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.
Descrição

Second Cancers Requirement Systemic therapy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0751623
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C1515119
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Similar models

Eligibility Carcinoma, Non-Small-Cell Lung NCT01545947

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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])
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