ID

37237

Description

AZD2014 and Weekly Paclitaxel in Squamous NSCLC; ODM derived from: https://clinicaltrials.gov/show/NCT02403895

Link

https://clinicaltrials.gov/show/NCT02403895

Keywords

Versions (1)
  1. 7/10/19 7/10/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 10, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Squamous Non Small Cell Lung Cancer NCT02403895

English

Eligibility Squamous Non Small Cell Lung Cancer NCT02403895

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histologically or cytologically proven squamous non-small cell lung cancer (nsclc) where treatment with weekly paclitaxel is an appropriate treatment option.
Description

Squamous non-small cell lung cancer | Paclitaxel Treatment option

Data type

boolean

Alias
UMLS CUI [1]
C4509816
UMLS CUI [2,1]
C0144576
UMLS CUI [2,2]
C0683525
2. relapsed or refractory disease after at least one line of prior therapy. subjects must have previously received appropriate line(s) of standard of care (soc) treatment.
Description

Recurrent disease | Refractory Disease | Status post Prior Therapy Quantity | Standard of Care Previous

Data type

boolean

Alias
UMLS CUI [1]
C0277556
UMLS CUI [2]
C1514815
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C1514463
UMLS CUI [3,3]
C1265611
UMLS CUI [4,1]
C2936643
UMLS CUI [4,2]
C0205156
3. measurable disease by recist v1.1 criteria
Description

Measurable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
4. life expectancy of at least 12 weeks.
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
5. eastern cooperative oncology group (ecog) performance status of 0 or 1.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. radiotherapy (except for palliative reasons), chemotherapy, endocrine therapy, or immunotherapy during the previous 3 weeks (4 weeks for investigational medicinal products and 6 weeks for nitrosoureas and mitomycin-c) before treatment.
Description

Therapeutic radiology procedure | Exception Palliative course of radiotherapy | Chemotherapy | Hormone Therapy | Immunotherapy | Investigational New Drugs | Nitrosoureas | Mitomycin

Data type

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0475092
UMLS CUI [3]
C0392920
UMLS CUI [4]
C0279025
UMLS CUI [5]
C0021083
UMLS CUI [6]
C0013230
UMLS CUI [7]
C0028210
UMLS CUI [8]
C0002475
2. ongoing toxic manifestations of previous treatments. exceptions to this are alopecia or grade 1 toxicities which, in the opinion of the investigator, should not exclude the patient.
Description

Toxicity Due to Prior Therapy | Exception Alopecia | Exception Toxicity CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C1514463
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0002170
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0600688
UMLS CUI [3,3]
C1516728
3. known leptomeningeal involvement, brain metastases or spinal cord compression.
Description

Involvement Leptomeningeal | Metastatic malignant neoplasm to brain | Compression of spinal cord

Data type

boolean

Alias
UMLS CUI [1,1]
C1314939
UMLS CUI [1,2]
C0521401
UMLS CUI [2]
C0220650
UMLS CUI [3]
C0037926
4. history of hypersensitivity (> grade 2) to active or inactive excipients of azd2014, drugs containing cremophor, taxanes or structurally/chemically similar drugs
Description

Hypersensitivity Grade AZD2014 Excipient | Pharmaceutical Preparations Containing Cremophor | Pharmaceutical Preparations Containing Taxanes | Pharmaceutical Preparations Similar

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0441800
UMLS CUI [1,3]
C2981846
UMLS CUI [1,4]
C0015237
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0332256
UMLS CUI [2,3]
C0056475
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C0332256
UMLS CUI [3,3]
C0796419
UMLS CUI [4,1]
C0013227
UMLS CUI [4,2]
C2348205
5. current refractory nausea and vomiting, chronic gastrointestinal disease, inability to swallow formulated product or previous significant bowel resection that would preclude adequate absorption of azd2014
Description

Intractable nausea and vomiting | Gastrointestinal Disease chronic | Lacking Able to swallow Oral medication | Bowel resection Excludes Absorption AZD2014

Data type

boolean

Alias
UMLS CUI [1]
C3697880
UMLS CUI [2,1]
C0017178
UMLS CUI [2,2]
C0205191
UMLS CUI [3,1]
C0332268
UMLS CUI [3,2]
C2712086
UMLS CUI [3,3]
C0175795
UMLS CUI [4,1]
C0741614
UMLS CUI [4,2]
C0332196
UMLS CUI [4,3]
C0237442
UMLS CUI [4,4]
C2981846
6. patients with diabetes type i or uncontrolled type ii (hba1c > 59 mmol/mol assessed locally) as judged by the investigator
Description

Diabetes Mellitus, Insulin-Dependent | DIABETES MELLITUS NON INSULIN DEPENDENT UNCONTROLLED | Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0743118
UMLS CUI [3]
C0474680
7. major surgery within 4 weeks prior to entry to the study (excluding placement of vascular access), or minor surgery within 2 weeks of entry into the study and from which the patient has not yet recovered
Description

Major surgery | Exception Vascular Access Placement | Minor Surgical Procedures Recovery Lacking

Data type

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1519955
UMLS CUI [3,1]
C0038904
UMLS CUI [3,2]
C2004454
UMLS CUI [3,3]
C0332268
8. adequate hematologic function independent of transfusion and growth factor support for at least 7 days prior to screening (with the exception of pegylated g-csf (pegfilgrastim) and darbepoetin which require at least 14 days prior to screening), defined as:
Description

Hematologic function | Independent of Transfusion | Independent of Growth Factor Support

Data type

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2,1]
C0332291
UMLS CUI [2,2]
C1879316
UMLS CUI [3,1]
C0332291
UMLS CUI [3,2]
C0018284
UMLS CUI [3,3]
C1521721
absolute neutrophil count 1500 cells/mm3 (1.5 x 109/l)
Description

Absolute neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0948762
platelet count 100.000 cells/mm3 (100 x 109/l)
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
haemoglobin 9.0 g/dl
Description

Hemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0518015
9. adequate hepatic and renal function defined as:
Description

Liver function | Renal function

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
serum aspartate transaminase (ast) or alanine transaminase (alt) 2.5 x upper limit of normal (uln) if no demonstrable liver metastases or 5 x uln in the presence of liver metastases
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0151904
UMLS CUI [2]
C0151905
UMLS CUI [3,1]
C0494165
UMLS CUI [3,2]
C0332197
UMLS CUI [4]
C0494165
alkaline phosphatase (alp) < 5 x uln
Description

Alkaline phosphatase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201850
serum bilirubin 1.5 x uln (unless bilirubin rise is due to gilbert's syndrome or of non-hepatic origin)
Description

SERUM TOTAL BILIRUBIN ELEVATED | Exception Relationship Gilbert Disease | Exception HEPATIC ETIOLOGY Absent

Data type

boolean

Alias
UMLS CUI [1]
C0595866
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0439849
UMLS CUI [2,3]
C0017551
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0744815
UMLS CUI [3,3]
C0332197
estimated creatinine clearance 50 ml/min (cockcroft-gault) or serum creatinine 1.5 x uln
Description

Estimation of creatinine clearance by Cockcroft-Gault formula | Serum creatinine raised

Data type

boolean

Alias
UMLS CUI [1]
C2711451
UMLS CUI [2]
C0700225
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Similar models

Eligibility Squamous Non Small Cell Lung Cancer NCT02403895

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Squamous non-small cell lung cancer | Paclitaxel Treatment option
Item
1. histologically or cytologically proven squamous non-small cell lung cancer (nsclc) where treatment with weekly paclitaxel is an appropriate treatment option.
boolean
C4509816 (UMLS CUI [1])
C0144576 (UMLS CUI [2,1])
C0683525 (UMLS CUI [2,2])
Recurrent disease | Refractory Disease | Status post Prior Therapy Quantity | Standard of Care Previous
Item
2. relapsed or refractory disease after at least one line of prior therapy. subjects must have previously received appropriate line(s) of standard of care (soc) treatment.
boolean
C0277556 (UMLS CUI [1])
C1514815 (UMLS CUI [2])
C0231290 (UMLS CUI [3,1])
C1514463 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C2936643 (UMLS CUI [4,1])
C0205156 (UMLS CUI [4,2])
Measurable Disease
Item
3. measurable disease by recist v1.1 criteria
boolean
C1513041 (UMLS CUI [1])
Life Expectancy
Item
4. life expectancy of at least 12 weeks.
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
5. eastern cooperative oncology group (ecog) performance status of 0 or 1.
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Therapeutic radiology procedure | Exception Palliative course of radiotherapy | Chemotherapy | Hormone Therapy | Immunotherapy | Investigational New Drugs | Nitrosoureas | Mitomycin
Item
1. radiotherapy (except for palliative reasons), chemotherapy, endocrine therapy, or immunotherapy during the previous 3 weeks (4 weeks for investigational medicinal products and 6 weeks for nitrosoureas and mitomycin-c) before treatment.
boolean
C1522449 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0475092 (UMLS CUI [2,2])
C0392920 (UMLS CUI [3])
C0279025 (UMLS CUI [4])
C0021083 (UMLS CUI [5])
C0013230 (UMLS CUI [6])
C0028210 (UMLS CUI [7])
C0002475 (UMLS CUI [8])
Toxicity Due to Prior Therapy | Exception Alopecia | Exception Toxicity CTCAE Grades
Item
2. ongoing toxic manifestations of previous treatments. exceptions to this are alopecia or grade 1 toxicities which, in the opinion of the investigator, should not exclude the patient.
boolean
C0600688 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C1514463 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0002170 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0600688 (UMLS CUI [3,2])
C1516728 (UMLS CUI [3,3])
Involvement Leptomeningeal | Metastatic malignant neoplasm to brain | Compression of spinal cord
Item
3. known leptomeningeal involvement, brain metastases or spinal cord compression.
boolean
C1314939 (UMLS CUI [1,1])
C0521401 (UMLS CUI [1,2])
C0220650 (UMLS CUI [2])
C0037926 (UMLS CUI [3])
Hypersensitivity Grade AZD2014 Excipient | Pharmaceutical Preparations Containing Cremophor | Pharmaceutical Preparations Containing Taxanes | Pharmaceutical Preparations Similar
Item
4. history of hypersensitivity (> grade 2) to active or inactive excipients of azd2014, drugs containing cremophor, taxanes or structurally/chemically similar drugs
boolean
C0020517 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C2981846 (UMLS CUI [1,3])
C0015237 (UMLS CUI [1,4])
C0013227 (UMLS CUI [2,1])
C0332256 (UMLS CUI [2,2])
C0056475 (UMLS CUI [2,3])
C0013227 (UMLS CUI [3,1])
C0332256 (UMLS CUI [3,2])
C0796419 (UMLS CUI [3,3])
C0013227 (UMLS CUI [4,1])
C2348205 (UMLS CUI [4,2])
Intractable nausea and vomiting | Gastrointestinal Disease chronic | Lacking Able to swallow Oral medication | Bowel resection Excludes Absorption AZD2014
Item
5. current refractory nausea and vomiting, chronic gastrointestinal disease, inability to swallow formulated product or previous significant bowel resection that would preclude adequate absorption of azd2014
boolean
C3697880 (UMLS CUI [1])
C0017178 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0332268 (UMLS CUI [3,1])
C2712086 (UMLS CUI [3,2])
C0175795 (UMLS CUI [3,3])
C0741614 (UMLS CUI [4,1])
C0332196 (UMLS CUI [4,2])
C0237442 (UMLS CUI [4,3])
C2981846 (UMLS CUI [4,4])
Diabetes Mellitus, Insulin-Dependent | DIABETES MELLITUS NON INSULIN DEPENDENT UNCONTROLLED | Hemoglobin A1c measurement
Item
6. patients with diabetes type i or uncontrolled type ii (hba1c > 59 mmol/mol assessed locally) as judged by the investigator
boolean
C0011854 (UMLS CUI [1])
C0743118 (UMLS CUI [2])
C0474680 (UMLS CUI [3])
Major surgery | Exception Vascular Access Placement | Minor Surgical Procedures Recovery Lacking
Item
7. major surgery within 4 weeks prior to entry to the study (excluding placement of vascular access), or minor surgery within 2 weeks of entry into the study and from which the patient has not yet recovered
boolean
C0679637 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1519955 (UMLS CUI [2,2])
C0038904 (UMLS CUI [3,1])
C2004454 (UMLS CUI [3,2])
C0332268 (UMLS CUI [3,3])
Hematologic function | Independent of Transfusion | Independent of Growth Factor Support
Item
8. adequate hematologic function independent of transfusion and growth factor support for at least 7 days prior to screening (with the exception of pegylated g-csf (pegfilgrastim) and darbepoetin which require at least 14 days prior to screening), defined as:
boolean
C0221130 (UMLS CUI [1])
C0332291 (UMLS CUI [2,1])
C1879316 (UMLS CUI [2,2])
C0332291 (UMLS CUI [3,1])
C0018284 (UMLS CUI [3,2])
C1521721 (UMLS CUI [3,3])
Absolute neutrophil count
Item
absolute neutrophil count 1500 cells/mm3 (1.5 x 109/l)
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count 100.000 cells/mm3 (100 x 109/l)
boolean
C0032181 (UMLS CUI [1])
Hemoglobin measurement
Item
haemoglobin 9.0 g/dl
boolean
C0518015 (UMLS CUI [1])
Liver function | Renal function
Item
9. adequate hepatic and renal function defined as:
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
Aspartate aminotransferase increased | Alanine aminotransferase increased | Secondary malignant neoplasm of liver Absent | Secondary malignant neoplasm of liver
Item
serum aspartate transaminase (ast) or alanine transaminase (alt) 2.5 x upper limit of normal (uln) if no demonstrable liver metastases or 5 x uln in the presence of liver metastases
boolean
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0494165 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0494165 (UMLS CUI [4])
Alkaline phosphatase measurement
Item
alkaline phosphatase (alp) < 5 x uln
boolean
C0201850 (UMLS CUI [1])
SERUM TOTAL BILIRUBIN ELEVATED | Exception Relationship Gilbert Disease | Exception HEPATIC ETIOLOGY Absent
Item
serum bilirubin 1.5 x uln (unless bilirubin rise is due to gilbert's syndrome or of non-hepatic origin)
boolean
C0595866 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C0017551 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0744815 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Estimation of creatinine clearance by Cockcroft-Gault formula | Serum creatinine raised
Item
estimated creatinine clearance 50 ml/min (cockcroft-gault) or serum creatinine 1.5 x uln
boolean
C2711451 (UMLS CUI [1])
C0700225 (UMLS CUI [2])
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