ID

27487

Beschrijving

Trial of BI 6727 (Volasertib) Monotherapy and BI 6727 in Combination With Pemetrexed Compared to Pemetrexed Monotherapy in Advanced NSCLC; ODM derived from: https://clinicaltrials.gov/show/NCT00824408

Link

https://clinicaltrials.gov/show/NCT00824408

Trefwoorden

Versies (1)
  1. 16-11-17 16-11-17 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

16 november 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Carcinoma, Non-Small-Cell Lung NCT00824408

Engels

Eligibility Carcinoma, Non-Small-Cell Lung NCT00824408

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. pathologic or cytologic confirmed diagnosis of nsclc
Beschrijving

Non-Small Cell Lung Carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C0007131
2. recurrent, advanced or metastatic nsclc that has progressed following one prior platinum based chemotherapy regimen (not counting adjuvant or neoadjuvant chemotherapy if completed more than 12 months prior to platinum based therapy)
Beschrijving

Non-small cell lung cancer recurrent | Non-Small Cell Lung Carcinoma Advanced | Non-small cell lung cancer metastatic | Prior Chemotherapy Platinum | Disease Progression

Datatype

boolean

Alias
UMLS CUI [1]
C0278517
UMLS CUI [2,1]
C0007131
UMLS CUI [2,2]
C0205179
UMLS CUI [3]
C0278987
UMLS CUI [4,1]
C1514457
UMLS CUI [4,2]
C0032207
UMLS CUI [5]
C0242656
3. patients who are eligible for pemetrexed as second line chemotherapy
Beschrijving

Eligibility Pemetrexed Chemotherapy Second line treatment

Datatype

boolean

Alias
UMLS CUI [1,1]
C1548635
UMLS CUI [1,2]
C0210657
UMLS CUI [1,3]
C0392920
UMLS CUI [1,4]
C1710038
4. measurable disease by one or more techniques (ct, mri) according to recist
Beschrijving

Measurable Disease CT | Measurable Disease MRI

Datatype

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0040405
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C0024485
5. patients aged 18 years or older
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
6. life expectancy of at least three (3) months
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
7. eastern cooperative oncology group (ecog) performance score 0-2
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
8. written informed consent that is consistent with ich-gcp guidelines and local legislation
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. treatment with an investigational drug in another clinical study within the past 28 days prior to the start of therapy or concomitantly with this study
Beschrijving

Study Subject Participation Status | Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
2. anti-cancer therapy for nsclc (except radiotherapy for palliative reasons) within the past 28 days prior to treatment day 1 of cycle 1 of this trial
Beschrijving

Cancer treatment Non-Small Cell Lung Carcinoma | Exception Palliative course of radiotherapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0007131
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0475092
3. any persisting toxicities which are deemed to be clinically significant from the previous therapy
Beschrijving

Toxicity persistent Due to Prior Therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C0205322
UMLS CUI [1,3]
C0678226
UMLS CUI [1,4]
C1514463
4. patients who have received more than one prior chemotherapy regimen for advanced disease (not including prior adjuvant therapy). patients may have received prior epidermal growth factor receptor tyrosine kinase inhibitors.
Beschrijving

Prior Chemotherapy Quantity Advanced disease | Exception Adjuvant therapy | EGFR Tyrosine Kinase Inhibitors allowed

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0679246
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0677850
UMLS CUI [3,1]
C1443775
UMLS CUI [3,2]
C0683607
5. patients who are unwilling or unable to take folic acid and vitamin b12 supplementation
Beschrijving

Folic acid supplementation Intake Unwilling | Folic acid supplementation Intake Unable | Vitamin B12 supplement Intake Unwilling | Vitamin B12 supplement Intake Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0556110
UMLS CUI [1,2]
C1512806
UMLS CUI [1,3]
C0558080
UMLS CUI [2,1]
C0556110
UMLS CUI [2,2]
C1512806
UMLS CUI [2,3]
C1299582
UMLS CUI [3,1]
C3661610
UMLS CUI [3,2]
C1512806
UMLS CUI [3,3]
C0558080
UMLS CUI [4,1]
C3661610
UMLS CUI [4,2]
C1512806
UMLS CUI [4,3]
C1299582
6. active brain metastases (stable for <28 days, symptomatic, or requiring concurrent steroids). patients who have received prior whole brain irradiation and whose brain metastases are stable according to the criteria above will not be excluded.
Beschrijving

Metastatic malignant neoplasm to brain Stable short-term | Metastatic malignant neoplasm to brain Symptomatic | Metastatic malignant neoplasm to brain Requirement Steroids | Whole brain radiotherapy allowed | Metastatic malignant neoplasm to brain Stable Long-term allowed

Datatype

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C0443303
UMLS CUI [2,1]
C0220650
UMLS CUI [2,2]
C0231220
UMLS CUI [3,1]
C0220650
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C0038317
UMLS CUI [4,1]
C1520143
UMLS CUI [4,2]
C0683607
UMLS CUI [5,1]
C0220650
UMLS CUI [5,2]
C0205360
UMLS CUI [5,3]
C0443252
UMLS CUI [5,4]
C0683607
7. other active malignancy diagnosed within the past 3 years (other than non melanomatous skin cancer and cervical intraepithelial neoplasia)
Beschrijving

Cancer Other | Exception Skin carcinoma | Exception Cervical Intraepithelial Neoplasia

Datatype

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0206708
8. concomitant intercurrent illnesses including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness or social situation that would limit compliance with trial requirement or which are considered relevant for the evaluation of the efficacy or safety of the trial drug
Beschrijving

Comorbidity | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Protocol Compliance Limited | Social situation Protocol Compliance Limited | Mental disorders Relevance Evaluation Investigational New Drugs | Social situation Relevance Evaluation Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0009450
UMLS CUI [3]
C0742758
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0003811
UMLS CUI [6,1]
C0004936
UMLS CUI [6,2]
C0525058
UMLS CUI [6,3]
C0439801
UMLS CUI [7,1]
C0748872
UMLS CUI [7,2]
C0525058
UMLS CUI [7,3]
C0439801
UMLS CUI [8,1]
C0004936
UMLS CUI [8,2]
C2347946
UMLS CUI [8,3]
C1261322
UMLS CUI [8,4]
C0013230
UMLS CUI [9,1]
C0748872
UMLS CUI [9,2]
C2347946
UMLS CUI [9,3]
C1261322
UMLS CUI [9,4]
C0013230
9. patients unable or unwilling to interrupt concomitant administration of nsaids 5 days prior to, the day of and 2 days after the administration of pemetrexed, with the exception of lose dose aspirin 81mg daily
Beschrijving

NSAIDs Unable to discontinue | NSAIDs Discontinue Unwilling | Exception Aspirin Low Dose U/day

Datatype

boolean

Alias
UMLS CUI [1,1]
C0003211
UMLS CUI [1,2]
C1548265
UMLS CUI [2,1]
C0003211
UMLS CUI [2,2]
C1444662
UMLS CUI [2,3]
C0558080
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C2608320
UMLS CUI [3,3]
C0456683
10. patients who have received prior therapy with pemetrexed
Beschrijving

pemetrexed

Datatype

boolean

Alias
UMLS CUI [1]
C0210657
11. absolute neutrophil count (anc) less than 1,500/mm3
Beschrijving

Absolute neutrophil count

Datatype

boolean

Alias
UMLS CUI [1]
C0948762
12. platelet count less than 100,000/mm3
Beschrijving

Platelet Count measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0032181
13. hemoglobin <90g/l
Beschrijving

Hemoglobin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0518015
14. total bilirubin >26µmol/l
Beschrijving

Serum total bilirubin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C1278039
15. alanine amino transferase (alt) and/or aspartate amino transferase (ast) less than 2.5 x uln, except in case of known liver metastasis where maximum 5 x uln is acceptable
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0494165
16. serum creatinine level >133µmol/l and/or creatinine clearance (measured or calculated) <45 ml/min
Beschrijving

Creatinine measurement, serum | Creatinine clearance measurement | Estimation of creatinine clearance by Cockcroft-Gault formula

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0373595
UMLS CUI [3]
C2711451
17. clinically relevant qtc prolongation
Beschrijving

Prolonged QTc

Datatype

boolean

Alias
UMLS CUI [1]
C1969409
18. women and men who are sexually active and unwilling to use a medically acceptable method of contraception
Beschrijving

Sexually active Contraceptive methods Unwilling

Datatype

boolean

Alias
UMLS CUI [1,1]
C0241028
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0558080
19. pregnancy or breast feeding
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
20. known or suspected active alcohol or drug abuse
Beschrijving

Substance Use Disorders | Substance Use Disorders Suspected

Datatype

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2,1]
C0038586
UMLS CUI [2,2]
C0750491
21. patients unable to comply with the protocol
Beschrijving

Protocol Compliance Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
22. any known hypersensitivity to the trial drugs or their excipients
Beschrijving

Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drugs Excipient

Datatype

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
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Similar models

Eligibility Carcinoma, Non-Small-Cell Lung NCT00824408

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma
Item
1. pathologic or cytologic confirmed diagnosis of nsclc
boolean
C0007131 (UMLS CUI [1])
Non-small cell lung cancer recurrent | Non-Small Cell Lung Carcinoma Advanced | Non-small cell lung cancer metastatic | Prior Chemotherapy Platinum | Disease Progression
Item
2. recurrent, advanced or metastatic nsclc that has progressed following one prior platinum based chemotherapy regimen (not counting adjuvant or neoadjuvant chemotherapy if completed more than 12 months prior to platinum based therapy)
boolean
C0278517 (UMLS CUI [1])
C0007131 (UMLS CUI [2,1])
C0205179 (UMLS CUI [2,2])
C0278987 (UMLS CUI [3])
C1514457 (UMLS CUI [4,1])
C0032207 (UMLS CUI [4,2])
C0242656 (UMLS CUI [5])
Eligibility Pemetrexed Chemotherapy Second line treatment
Item
3. patients who are eligible for pemetrexed as second line chemotherapy
boolean
C1548635 (UMLS CUI [1,1])
C0210657 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
C1710038 (UMLS CUI [1,4])
Measurable Disease CT | Measurable Disease MRI
Item
4. measurable disease by one or more techniques (ct, mri) according to recist
boolean
C1513041 (UMLS CUI [1,1])
C0040405 (UMLS CUI [1,2])
C1513041 (UMLS CUI [2,1])
C0024485 (UMLS CUI [2,2])
Age
Item
5. patients aged 18 years or older
boolean
C0001779 (UMLS CUI [1])
Life Expectancy
Item
6. life expectancy of at least three (3) months
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
7. eastern cooperative oncology group (ecog) performance score 0-2
boolean
C1520224 (UMLS CUI [1])
Informed Consent
Item
8. written informed consent that is consistent with ich-gcp guidelines and local legislation
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status | Investigational New Drugs
Item
1. treatment with an investigational drug in another clinical study within the past 28 days prior to the start of therapy or concomitantly with this study
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Cancer treatment Non-Small Cell Lung Carcinoma | Exception Palliative course of radiotherapy
Item
2. anti-cancer therapy for nsclc (except radiotherapy for palliative reasons) within the past 28 days prior to treatment day 1 of cycle 1 of this trial
boolean
C0920425 (UMLS CUI [1,1])
C0007131 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0475092 (UMLS CUI [2,2])
Toxicity persistent Due to Prior Therapy
Item
3. any persisting toxicities which are deemed to be clinically significant from the previous therapy
boolean
C0600688 (UMLS CUI [1,1])
C0205322 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C1514463 (UMLS CUI [1,4])
Prior Chemotherapy Quantity Advanced disease | Exception Adjuvant therapy | EGFR Tyrosine Kinase Inhibitors allowed
Item
4. patients who have received more than one prior chemotherapy regimen for advanced disease (not including prior adjuvant therapy). patients may have received prior epidermal growth factor receptor tyrosine kinase inhibitors.
boolean
C1514457 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0679246 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0677850 (UMLS CUI [2,2])
C1443775 (UMLS CUI [3,1])
C0683607 (UMLS CUI [3,2])
Folic acid supplementation Intake Unwilling | Folic acid supplementation Intake Unable | Vitamin B12 supplement Intake Unwilling | Vitamin B12 supplement Intake Unable
Item
5. patients who are unwilling or unable to take folic acid and vitamin b12 supplementation
boolean
C0556110 (UMLS CUI [1,1])
C1512806 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C0556110 (UMLS CUI [2,1])
C1512806 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
C3661610 (UMLS CUI [3,1])
C1512806 (UMLS CUI [3,2])
C0558080 (UMLS CUI [3,3])
C3661610 (UMLS CUI [4,1])
C1512806 (UMLS CUI [4,2])
C1299582 (UMLS CUI [4,3])
Metastatic malignant neoplasm to brain Stable short-term | Metastatic malignant neoplasm to brain Symptomatic | Metastatic malignant neoplasm to brain Requirement Steroids | Whole brain radiotherapy allowed | Metastatic malignant neoplasm to brain Stable Long-term allowed
Item
6. active brain metastases (stable for <28 days, symptomatic, or requiring concurrent steroids). patients who have received prior whole brain irradiation and whose brain metastases are stable according to the criteria above will not be excluded.
boolean
C0220650 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0443303 (UMLS CUI [1,3])
C0220650 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0220650 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0038317 (UMLS CUI [3,3])
C1520143 (UMLS CUI [4,1])
C0683607 (UMLS CUI [4,2])
C0220650 (UMLS CUI [5,1])
C0205360 (UMLS CUI [5,2])
C0443252 (UMLS CUI [5,3])
C0683607 (UMLS CUI [5,4])
Cancer Other | Exception Skin carcinoma | Exception Cervical Intraepithelial Neoplasia
Item
7. other active malignancy diagnosed within the past 3 years (other than non melanomatous skin cancer and cervical intraepithelial neoplasia)
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0206708 (UMLS CUI [3,2])
Comorbidity | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Protocol Compliance Limited | Social situation Protocol Compliance Limited | Mental disorders Relevance Evaluation Investigational New Drugs | Social situation Relevance Evaluation Investigational New Drugs
Item
8. concomitant intercurrent illnesses including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness or social situation that would limit compliance with trial requirement or which are considered relevant for the evaluation of the efficacy or safety of the trial drug
boolean
C0009488 (UMLS CUI [1])
C0009450 (UMLS CUI [2])
C0742758 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5])
C0004936 (UMLS CUI [6,1])
C0525058 (UMLS CUI [6,2])
C0439801 (UMLS CUI [6,3])
C0748872 (UMLS CUI [7,1])
C0525058 (UMLS CUI [7,2])
C0439801 (UMLS CUI [7,3])
C0004936 (UMLS CUI [8,1])
C2347946 (UMLS CUI [8,2])
C1261322 (UMLS CUI [8,3])
C0013230 (UMLS CUI [8,4])
C0748872 (UMLS CUI [9,1])
C2347946 (UMLS CUI [9,2])
C1261322 (UMLS CUI [9,3])
C0013230 (UMLS CUI [9,4])
NSAIDs Unable to discontinue | NSAIDs Discontinue Unwilling | Exception Aspirin Low Dose U/day
Item
9. patients unable or unwilling to interrupt concomitant administration of nsaids 5 days prior to, the day of and 2 days after the administration of pemetrexed, with the exception of lose dose aspirin 81mg daily
boolean
C0003211 (UMLS CUI [1,1])
C1548265 (UMLS CUI [1,2])
C0003211 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C2608320 (UMLS CUI [3,2])
C0456683 (UMLS CUI [3,3])
pemetrexed
Item
10. patients who have received prior therapy with pemetrexed
boolean
C0210657 (UMLS CUI [1])
Absolute neutrophil count
Item
11. absolute neutrophil count (anc) less than 1,500/mm3
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
12. platelet count less than 100,000/mm3
boolean
C0032181 (UMLS CUI [1])
Hemoglobin measurement
Item
13. hemoglobin <90g/l
boolean
C0518015 (UMLS CUI [1])
Serum total bilirubin measurement
Item
14. total bilirubin >26µmol/l
boolean
C1278039 (UMLS CUI [1])
Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Exception Secondary malignant neoplasm of liver
Item
15. alanine amino transferase (alt) and/or aspartate amino transferase (ast) less than 2.5 x uln, except in case of known liver metastasis where maximum 5 x uln is acceptable
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0494165 (UMLS CUI [3,2])
Creatinine measurement, serum | Creatinine clearance measurement | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
16. serum creatinine level >133µmol/l and/or creatinine clearance (measured or calculated) <45 ml/min
boolean
C0201976 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
C2711451 (UMLS CUI [3])
Prolonged QTc
Item
17. clinically relevant qtc prolongation
boolean
C1969409 (UMLS CUI [1])
Sexually active Contraceptive methods Unwilling
Item
18. women and men who are sexually active and unwilling to use a medically acceptable method of contraception
boolean
C0241028 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
Pregnancy | Breast Feeding
Item
19. pregnancy or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Substance Use Disorders | Substance Use Disorders Suspected
Item
20. known or suspected active alcohol or drug abuse
boolean
C0038586 (UMLS CUI [1])
C0038586 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
Protocol Compliance Unable
Item
21. patients unable to comply with the protocol
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drugs Excipient
Item
22. any known hypersensitivity to the trial drugs or their 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])
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