ID

35018

Descrição

A Multi-Center Study of Ibrutinib in Combination With MEDI4736 in Subjects With Relapsed or Refractory Solid Tumors; ODM derived from: https://clinicaltrials.gov/show/NCT02403271

Link

https://clinicaltrials.gov/show/NCT02403271

Palavras-chave

Versões (1)
  1. 10/02/2019 10/02/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

10 de fevereiro de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02403271

Inglês

Eligibility Breast Cancer NCT02403271

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. pathologically confirmed:
Descrição

Confirmed by Pathology

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0521093
UMLS CUI [1,2]
C0919386
non-small cell lung cancer (nsclc, adenocarcinoma or squamous-cell carcinoma) or
Descrição

Non-Small Cell Lung Carcinoma | Adenocarcinoma of lung | Squamous cell carcinoma of lung

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0007131
UMLS CUI [2]
C0152013
UMLS CUI [3]
C0149782
breast cancer (her2 positive or triple negative) or
Descrição

HER2-positive carcinoma of breast | Triple Negative Breast Neoplasm

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1960398
UMLS CUI [2]
C3539878
pancreatic cancer (adenocarcinoma)
Descrição

Pancreatic carcinoma | Adenocarcinoma of pancreas

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0235974
UMLS CUI [2]
C0281361
2. relapsed or refractory disease (stage iii or iv): nsclc or pancreatic cancer must have failed at least 1 prior treatment. breast cancer must have failed at least 2 prior treatments.
Descrição

Recurrent disease TNM clinical staging | Refractory Disease TNM clinical staging | Non-Small Cell Lung Carcinoma | Pancreatic carcinoma | Prior Therapy Quantity failed | Breast Carcinoma

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0277556
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C1514815
UMLS CUI [2,2]
C3258246
UMLS CUI [3]
C0007131
UMLS CUI [4]
C0235974
UMLS CUI [5,1]
C1514463
UMLS CUI [5,2]
C1265611
UMLS CUI [5,3]
C0231175
UMLS CUI [6]
C0678222
3. measurable lesion by recist 1.1
Descrição

Measurable lesion

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1513041
4. adequate hematologic function:
Descrição

Hematologic function

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0221130
anc >1500 cells/mm3
Descrição

Absolute neutrophil count

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0948762
platelet count >100,000 cells/mm3
Descrição

Platelet Count measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032181
hgb >9.0 g/dl
Descrição

Hemoglobin measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0518015
5. adequate hepatic and renal function:
Descrição

Liver function | Renal function

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
ast and alt ≤2.5 x uln for subjects without liver metastases and ≤3.5 x uln for subjects with liver metastases
Descrição

Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver Absent | Secondary malignant neoplasm of liver

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
UMLS CUI [3,1]
C0494165
UMLS CUI [3,2]
C0332197
UMLS CUI [4]
C0494165
bilirubin ≤1.5 x uln (unless bilirubin rise is due to gilbert's syndrome or of non-hepatic origin)
Descrição

Serum total bilirubin measurement | Exception Elevated total bilirubin Due to Gilbert Disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0741494
UMLS CUI [2,3]
C0678226
UMLS CUI [2,4]
C0017551
creatinine ≤2.0 x uln or creatinine clearance ≥40 ml/min
Descrição

Creatinine measurement, serum | Creatinine clearance measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0373595
6. pt/inr <1.5 x uln and ptt/ aptt <1.5 x uln
Descrição

Prothrombin time assay | International Normalized Ratio | Partial thromboplastin time | Activated Partial Thromboplastin Time measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0033707
UMLS CUI [2]
C0525032
UMLS CUI [3]
C1531697
UMLS CUI [4]
C0030605
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. mixed small cell and nsclc histology
Descrição

Histology Mixed | Small cell carcinoma of lung | Non-Small Cell Lung Carcinoma

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0344441
UMLS CUI [1,2]
C0205430
UMLS CUI [2]
C0149925
UMLS CUI [3]
C0007131
2. cns involvement of disease
Descrição

Central Nervous System Involvement Disease

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C4050309
UMLS CUI [1,2]
C0012634
3. anti-tumor therapy within 21 days of study day 1
Descrição

Cancer treatment

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0920425
4. prior treatment with ibrutinib or other btk inhibitor and/or anti-pd1, anti-pd-l1, anti-pd-l2, anti-cd137 or ctla-4 antibody
Descrição

Ibrutinib | Bruton tyrosine kinase inhibitors | Anti-PD1 Monoclonal Antibody | Anti-PD-L1 Monoclonal Antibody | Other Coding | urelumab | Anti-CTLA-4 Monoclonal Antibody

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3501358
UMLS CUI [2,1]
C0218158
UMLS CUI [2,2]
C0243077
UMLS CUI [3]
C4289970
UMLS CUI [4]
C4289971
UMLS CUI [5]
C3846158
UMLS CUI [6]
C1831875
UMLS CUI [7]
C4289973
5. history of allogeneic organ transplant
Descrição

Organ Transplantation Allogeneic

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0029216
UMLS CUI [1,2]
C1515895
6. treatment with a strong cytochrome p450 (cyp) 3a inhibitor
Descrição

CYP3A Inhibitors

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3850056
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Similar models

Eligibility Breast Cancer NCT02403271

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Confirmed by Pathology
Item
1. pathologically confirmed:
boolean
C0521093 (UMLS CUI [1,1])
C0919386 (UMLS CUI [1,2])
Non-Small Cell Lung Carcinoma | Adenocarcinoma of lung | Squamous cell carcinoma of lung
Item
non-small cell lung cancer (nsclc, adenocarcinoma or squamous-cell carcinoma) or
boolean
C0007131 (UMLS CUI [1])
C0152013 (UMLS CUI [2])
C0149782 (UMLS CUI [3])
HER2-positive carcinoma of breast | Triple Negative Breast Neoplasm
Item
breast cancer (her2 positive or triple negative) or
boolean
C1960398 (UMLS CUI [1])
C3539878 (UMLS CUI [2])
Pancreatic carcinoma | Adenocarcinoma of pancreas
Item
pancreatic cancer (adenocarcinoma)
boolean
C0235974 (UMLS CUI [1])
C0281361 (UMLS CUI [2])
Recurrent disease TNM clinical staging | Refractory Disease TNM clinical staging | Non-Small Cell Lung Carcinoma | Pancreatic carcinoma | Prior Therapy Quantity failed | Breast Carcinoma
Item
2. relapsed or refractory disease (stage iii or iv): nsclc or pancreatic cancer must have failed at least 1 prior treatment. breast cancer must have failed at least 2 prior treatments.
boolean
C0277556 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C1514815 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
C0007131 (UMLS CUI [3])
C0235974 (UMLS CUI [4])
C1514463 (UMLS CUI [5,1])
C1265611 (UMLS CUI [5,2])
C0231175 (UMLS CUI [5,3])
C0678222 (UMLS CUI [6])
Measurable lesion
Item
3. measurable lesion by recist 1.1
boolean
C1513041 (UMLS CUI [1])
Hematologic function
Item
4. adequate hematologic function:
boolean
C0221130 (UMLS CUI [1])
Absolute neutrophil count
Item
anc >1500 cells/mm3
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count >100,000 cells/mm3
boolean
C0032181 (UMLS CUI [1])
Hemoglobin measurement
Item
hgb >9.0 g/dl
boolean
C0518015 (UMLS CUI [1])
Liver function | Renal function
Item
5. adequate hepatic and renal function:
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver Absent | Secondary malignant neoplasm of liver
Item
ast and alt ≤2.5 x uln for subjects without liver metastases and ≤3.5 x uln for subjects with liver metastases
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0494165 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0494165 (UMLS CUI [4])
Serum total bilirubin measurement | Exception Elevated total bilirubin Due to Gilbert Disease
Item
bilirubin ≤1.5 x uln (unless bilirubin rise is due to gilbert's syndrome or of non-hepatic origin)
boolean
C1278039 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0741494 (UMLS CUI [2,2])
C0678226 (UMLS CUI [2,3])
C0017551 (UMLS CUI [2,4])
Creatinine measurement, serum | Creatinine clearance measurement
Item
creatinine ≤2.0 x uln or creatinine clearance ≥40 ml/min
boolean
C0201976 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Prothrombin time assay | International Normalized Ratio | Partial thromboplastin time | Activated Partial Thromboplastin Time measurement
Item
6. pt/inr <1.5 x uln and ptt/ aptt <1.5 x uln
boolean
C0033707 (UMLS CUI [1])
C0525032 (UMLS CUI [2])
C1531697 (UMLS CUI [3])
C0030605 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Histology Mixed | Small cell carcinoma of lung | Non-Small Cell Lung Carcinoma
Item
1. mixed small cell and nsclc histology
boolean
C0344441 (UMLS CUI [1,1])
C0205430 (UMLS CUI [1,2])
C0149925 (UMLS CUI [2])
C0007131 (UMLS CUI [3])
Central Nervous System Involvement Disease
Item
2. cns involvement of disease
boolean
C4050309 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
Cancer treatment
Item
3. anti-tumor therapy within 21 days of study day 1
boolean
C0920425 (UMLS CUI [1])
Ibrutinib | Bruton tyrosine kinase inhibitors | Anti-PD1 Monoclonal Antibody | Anti-PD-L1 Monoclonal Antibody | Other Coding | urelumab | Anti-CTLA-4 Monoclonal Antibody
Item
4. prior treatment with ibrutinib or other btk inhibitor and/or anti-pd1, anti-pd-l1, anti-pd-l2, anti-cd137 or ctla-4 antibody
boolean
C3501358 (UMLS CUI [1])
C0218158 (UMLS CUI [2,1])
C0243077 (UMLS CUI [2,2])
C4289970 (UMLS CUI [3])
C4289971 (UMLS CUI [4])
C3846158 (UMLS CUI [5])
C1831875 (UMLS CUI [6])
C4289973 (UMLS CUI [7])
Organ Transplantation Allogeneic
Item
5. history of allogeneic organ transplant
boolean
C0029216 (UMLS CUI [1,1])
C1515895 (UMLS CUI [1,2])
CYP3A Inhibitors
Item
6. treatment with a strong cytochrome p450 (cyp) 3a inhibitor
boolean
C3850056 (UMLS CUI [1])
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