ID

44616

Description

ODM derived from http://clinicaltrials.gov/show/NCT01085136

Lien

http://clinicaltrials.gov/show/NCT01085136

Mots-clés

Versions (3)
  1. 06/12/2013 06/12/2013 - Martin Dugas
  2. 17/04/2014 17/04/2014 - Julian Varghese
  3. 27/09/2021 27/09/2021 -
Téléchargé le

27 septembre 2021

DOI

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Licence

Creative Commons BY 4.0
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Eligibility NCT01085136 Carcinoma, Non-Small-Cell Lung

Allemand Anglais

Eligibility

1 Formulaires  
  1. StudyEvent: Eligibility
    1. Eligibility
Einschlusskriterien
Description

Einschlusskriterien

Alias
UMLS CUI 2011AA
CL425202
Alter mindestens 18 Jahre
Description

age at least 18 Years

Type de données

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Patients with pathologically confirmed diagnosis of NSCLC Stage IIIB (with cytologically proven pleural effusion or pericardial effusion) or Stage IV who have failed treatment with erlotinib (Tarceva) or gefitinib (Iressa).
Description

Patients with pathologically confirmed diagnosis of NSCLC Stage IIIB (with cytologically proven pleural effusion or pericardial effusion) or Stage IV who have failed treatment with erlotinib (Tarceva) or gefitinib (Iressa).

Type de données

boolean

Alias
UMLS CUI 2011AA
C1521733
SNOMED CT 2011_0131
29458008
UMLS CUI 2011AA
C0750484
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0278984
MedDRA 14.1
10029521
UMLS CUI 2011AA
C0032227
SNOMED CT 2011_0131
60046008
MedDRA 14.1
10035598
ICD-10-CM Version 2010
J90
ICD-9-CM Version 2011
511.9
CTCAE 1105E
E13486
UMLS CUI 2011AA
C0031039
SNOMED CT 2011_0131
373945007
MedDRA 14.1
10034474
CTCAE 1105E
E10172
UMLS CUI 2011AA
C0278987
MedDRA 14.1
10025055
UMLS CUI 2011AA
C0162643
MedDRA 14.1
10066901
UMLS CUI 2011AA
C1135135
SNOMED CT 2011_0131
414122006
UMLS CUI 2011AA
C0910101
SNOMED CT 2011_0131
426686007
UMLS CUI 2011AA
C1122962
SNOMED CT 2011_0131
398685009
Patients should have received and failed at least one line of cytotoxic chemotherapy including a platinum-based regimen in patients eligible for platinum-based therapy and pemetrexed in pemetrexed eligible patients (unless pemetrexed is not considered a regulatory or clinical standard of care e.g. no label indication, no availability or no coverage by 3rd party payer(s)) for advanced or metastatic disease and have progressive disease following at least 12 weeks of treatment with erlotinib or gefitinib
Description

Patients should have received and failed at least one line of cytotoxic chemotherapy including a platinum-based regimen in patients eligible for platinum-based therapy and pemetrexed in pemetrexed eligible patients (unless pemetrexed is not considered a regulatory or clinical standard of care e.g. no label indication, no availability or no coverage by 3rd party payer(s)) for advanced or metastatic disease and have progressive disease following at least 12 weeks of treatment with erlotinib or gefitinib

Type de données

boolean

Alias
UMLS CUI 2011AA
C0231175
UMLS CUI 2011AA
C0677881
UMLS CUI 2011AA
C0332257
SNOMED CT 2011_0131
55919000
UMLS CUI 2011AA
C1514162
UMLS CUI 2011AA
CL031856
UMLS CUI 2011AA
C0210657
SNOMED CT 2011_0131
411089001
Patients pretreated with taxane-based chemotherapy for advanced or metastatic disease must have experienced stable disease, partial or complete response as best response
Description

Patients pretreated with taxane-based chemotherapy for advanced or metastatic disease must have experienced stable disease, partial or complete response as best response

Type de données

boolean

Alias
UMLS CUI 2011AA
C1514457
UMLS CUI 2011AA
C0215136
UMLS CUI 2011AA
C1705938
UMLS CUI 2011AA
C0679246
UMLS CUI 2011AA
C0027627
MedDRA 14.1
10027478
UMLS CUI 2011AA
C0027552
SNOMED CT 2011_0131
410525008
UMLS CUI 2011AA
C0677946
UMLS CUI 2011AA
C1521726
SNOMED CT 2011_0131
103337004
UMLS CUI 2011AA
C0677874
SNOMED CT 2011_0131
103338009
UMLS CUI 2011AA
CL426196
Eastern Cooperative Oncology Group performance Score 0 or 1.
Description

Eastern Cooperative Oncology Group performance Score 0 or 1.

Type de données

boolean

Alias
UMLS CUI 2011AA
C1520224
Patients with at least one tumor lesion that can accurately be measured by magnetic resonance imaging (MRI), or computed tomography (CT) in at least one dimension with longest diameter to be recorded as 20 mm or greater using conventional techniques or10 mm or greater with spiral CT scan according to RESIST 1.1.
Description

Patients with at least one tumor lesion that can accurately be measured by magnetic resonance imaging (MRI), or computed tomography (CT) in at least one dimension with longest diameter to be recorded as 20 mm or greater using conventional techniques or10 mm or greater with spiral CT scan according to RESIST 1.1.

Type de données

boolean

Alias
UMLS CUI 2011AA
CL364385
UMLS CUI 2011AA
C0221198
SNOMED CT 2011_0131
49755003
UMLS CUI 2011AA
C0444706
SNOMED CT 2011_0131
258104002
UMLS CUI 2011AA
C0024485
SNOMED CT 2011_0131
113091000
MedDRA 14.1
10028049
UMLS CUI 2011AA
C0040405
SNOMED CT 2011_0131
77477000
MedDRA 14.1
10010234
HL7 V3 2006_05
0002
UMLS CUI 2011AA
C0860888
SNOMED CT 2011_0131
116152004
MedDRA 14.1
10041623
UMLS CUI 2011AA
C0332290
SNOMED CT 2011_0131
385433004
UMLS CUI 2011AA
C1709926
Life expectancy of >= three (3) months.
Description

Life expectancy of >= three (3) months.

Type de données

boolean

Alias
UMLS CUI 2011AA
C0023671
LOINC Version 232
LP75025-4
UMLS CUI 2011AA
C0439091
SNOMED CT 2011_0131
276138003
HL7 V3 2006_05
GE
UMLS CUI 2011AA
C0205449
SNOMED CT 2011_0131
421291004
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
Written informed consent that is consistent with ICH-GCP guidelines. Part B 1) Clinical benefit (disease stabilization or antitumor response) of 12 weeks duration in Part A of the trial determined on the second tumour assessment.
Description

Written informed consent that is consistent with ICH-GCP guidelines. Part B 1) Clinical benefit (disease stabilization or antitumor response) of 12 weeks duration in Part A of the trial determined on the second tumour assessment.

Type de données

boolean

Alias
UMLS CUI 2011AA
C0021430
Ausschlusskriterien
Description

Ausschlusskriterien

Alias
UMLS CUI 2011AA
CL425201
Chemo-, hormone- (other than megestrol acetate, steroids required for maintenance non-cancer therapy or as premedication before chemotherapy) or immunotherapy within the past 4 weeks; except for TKI pretreatment (2 weeks only)
Description

Chemo-, hormone- (other than megestrol acetate, steroids required for maintenance non-cancer therapy or as premedication before chemotherapy) or immunotherapy within the past 4 weeks; except for TKI pretreatment (2 weeks only)

Type de données

boolean

Alias
UMLS CUI 2011AA
C0392920
SNOMED CT 2011_0131
150415003
UMLS CUI 2011AA
C0279025
SNOMED CT 2011_0131
309542002, 169413002
MedDRA 14.1
10065646
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0065879
SNOMED CT 2011_0131
90357001
LOINC Version 232
MTHU018761
UMLS CUI 2011AA
C0038317
SNOMED CT 2011_0131
116566001
UMLS CUI 2011AA
C0021083
SNOMED CT 2011_0131
146638005
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C1268567
SNOMED CT 2011_0131
372917005
UMLS CUI 2011AA
C1882440
Active brain metastases (stable <4 weeks, symptomatic, requiring treatment with anticonvulsants, or leptomeningeal disease). Dexamethasone therapy will be allowed if administered as a stable dose for at least one month before randomization.
Description

Active brain metastases (stable <4 weeks, symptomatic, requiring treatment with anticonvulsants, or leptomeningeal disease). Dexamethasone therapy will be allowed if administered as a stable dose for at least one month before randomization.

Type de données

boolean

Alias
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C0220650
MedDRA 14.1
10006128
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0003299
SNOMED CT 2011_0131
255632006
LOINC Version 232
MTHU006781
UMLS CUI 2011AA
CL428853
MedDRA 14.1
10070973
Significant or recent acute gastrointestinal disorders with diarrhea as a major symptom e.g., Crohn's disease, mal-absorption, or CTCAE Grade >2 diarrhea of any etiology at baseline
Description

Significant or recent acute gastrointestinal disorders with diarrhea as a major symptom e.g., Crohn's disease, mal-absorption, or CTCAE Grade >2 diarrhea of any etiology at baseline

Type de données

boolean

Alias
UMLS CUI 2011AA
C0205178
SNOMED CT 2011_0131
272118002
UMLS CUI 2011AA
C0017178
SNOMED CT 2011_0131
119292006
MedDRA 14.1
10017944
UMLS CUI 2011AA
C0011991
SNOMED CT 2011_0131
62315008
MedDRA 14.1
10012735
LOINC Version 232
MTHU013347
ICD-10-CM Version 2010
R19.7
ICD-9-CM Version 2011
787.91
CTCAE 1105E
E10572
UMLS CUI 2011AA
C0010346
SNOMED CT 2011_0131
34000006
MedDRA 14.1
10011401
ICD-10-CM Version 2010
K50.9
UMLS CUI 2011AA
C0024523
SNOMED CT 2011_0131
155841000
ICD-10-CM Version 2010
K90.4
UMLS CUI 2011AA
C1559310
CTCAE 1105E
MTHU114261
UMLS CUI 2011AA
C1559311
CTCAE 1105E
MTHU115273
UMLS CUI 2011AA
C1559312
CTCAE 1105E
MTHU116177
Patients who have any other life-threatening illness or organ system dysfunction, which in the opinion of the Investigator, would either compromise patient safety or interfere with the evaluation of the safety of the test drug
Description

Patients who have any other life-threatening illness or organ system dysfunction, which in the opinion of the Investigator, would either compromise patient safety or interfere with the evaluation of the safety of the test drug

Type de données

boolean

Alias
UMLS CUI 2011AA
C2826244
UMLS CUI 2011AA
C0221423
SNOMED CT 2011_0131
39104002
MedDRA 14.1
10040658
ICD-10-CM Version 2010
R69
UMLS CUI 2011AA
C0460002
SNOMED CT 2011_0131
91689009
UMLS CUI 2011AA
C0277785
SNOMED CT 2011_0131
386585008
UMLS CUI 2011AA
C0221099
SNOMED CT 2011_0131
260379002
UMLS CUI 2011AA
C1113679
UMLS CUI 2011AA
C0521102
SNOMED CT 2011_0131
78235001
UMLS CUI 2011AA
C0013175
SNOMED CT 2011_0131
185922005
Other malignancies diagnosed within the past five (5) years (other than non-melanomatous skin cancer and in situ cervical cancer)
Description

Other malignancies diagnosed within the past five (5) years (other than non-melanomatous skin cancer and in situ cervical cancer)

Type de données

boolean

Alias
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0006826
SNOMED CT 2011_0131
363346000
MedDRA 14.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0699893
MedDRA 14.1
10040810
UMLS CUI 2011AA
C0851140
SNOMED CT 2011_0131
92564006
MedDRA 14.1
10061809
ICD-10-CM Version 2010
D06.9
ICD-9-CM Version 2011
233.1
Radiotherapy within the past 2 weeks prior to treatment with the trial drug
Description

Radiotherapy within the past 2 weeks prior to treatment with the trial drug

Type de données

boolean

Alias
UMLS CUI 2011AA
C0034619
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0304229
SNOMED CT 2011_0131
902003
History of clinically significant or uncontrolled cardiac disease, including congestive heart failure, angina, myocardial infarction, arrhythmia, including New York Heart Association (NYHA) functional classification of 3
Description

History of clinically significant or uncontrolled cardiac disease, including congestive heart failure, angina, myocardial infarction, arrhythmia, including New York Heart Association (NYHA) functional classification of 3

Type de données

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0018799
SNOMED CT 2011_0131
56265001
MedDRA 14.1
10061024
UMLS CUI 2011AA
C0018802
SNOMED CT 2011_0131
42343007
MedDRA 14.1
10007559
LOINC Version 232
MTHU020787
ICD-10-CM Version 2010
I50.9
ICD-9-CM Version 2011
428.0
UMLS CUI 2011AA
C0002962
SNOMED CT 2011_0131
194828000
MedDRA 14.1
10002383
ICD-10-CM Version 2010
I20
ICD-9-CM Version 2011
413
UMLS CUI 2011AA
C0027051
SNOMED CT 2011_0131
22298006
MedDRA 14.1
10028596
LOINC Version 232
MTHU035551
ICD-10-CM Version 2010
I21-I22
ICD-9-CM Version 2011
410
CTCAE 1105E
E10152
UMLS CUI 2011AA
C0003811
SNOMED CT 2011_0131
44808001
MedDRA 14.1
10003119
ICD-9-CM Version 2011
427.9
UMLS CUI 2011AA
C1319795
SNOMED CT 2011_0131
420913000
MedDRA 14.1
10064081
Cardiac left ventricular function with resting ejection fraction of < 50% measured by multigated blood pool imaging of the heart (MUGA scan) or echocardiogram
Description

Cardiac left ventricular function with resting ejection fraction of < 50% measured by multigated blood pool imaging of the heart (MUGA scan) or echocardiogram

Type de données

boolean

Alias
UMLS CUI 2011AA
C0428772
SNOMED CT 2011_0131
250908004
MedDRA 14.1
10069170
UMLS CUI 2011AA
C0017200
UMLS CUI 2011AA
C0521317
SNOMED CT 2011_0131
404221001
MedDRA 14.1
10028211
UMLS CUI 2011AA
C2243117
QTc-Intervall
Description

QTc interval at or > 0.47 second

Type de données

boolean

Alias
UMLS CUI 2011AA
C0489625
LOINC Version 232
MTHU024527
Prior treatment with anthracyclines with a cumulative dose of doxorubicin (or equivalent) at or > 400 mg/m2
Description

Prior treatment with anthracyclines with a cumulative dose of doxorubicin (or equivalent) at or > 400 mg/m2

Type de données

boolean

Alias
UMLS CUI 2011AA
C1514463
UMLS CUI 2011AA
C0282564
SNOMED CT 2011_0131
372540003
UMLS CUI 2011AA
CL426125
UMLS CUI 2011AA
C0013089
SNOMED CT 2011_0131
68444001
LOINC Version 232
MTHU004184
UMLS CUI 2011AA
CL415123
Absolute Neutrophil Count
Description

Absolute neutrophil count (ANC) at or < 1500 / mm3

Type de données

boolean

Alias
UMLS CUI 2011AA
C0948762
MedDRA 14.1
10052033
Thrombozyten
Description

Platelet count at or < 100,000 / mm3

Type de données

boolean

Alias
UMLS CUI 2011AA
C1287267
SNOMED CT 2011_0131
365632008
LOINC Version 232
777-3
Bilirubin at or > 1.5 mg / dL (>26 mol / L, SI unit equivalent)
Description

Bilirubin at or > 1.5 mg / dL (>26 mol / L, SI unit equivalent)

Type de données

boolean

Alias
UMLS CUI 2011AA
C0011221
SNOMED CT 2011_0131
79706000
LOINC Version 232
1975-2
UMLS CUI 2011AA
C1705302
UMLS CUI 2011AA
CL415123
Aspartate amino transferase (AST) or alanine amino transferase (ALT) at or > three times the upper limit of normal (if related to liver metastases at or > five times the upper limit of normal)
Description

Aspartate amino transferase (AST) or alanine amino transferase (ALT) at or > three times the upper limit of normal (if related to liver metastases at or > five times the upper limit of normal)

Type de données

boolean

Alias
UMLS CUI 2011AA
C0004002
SNOMED CT 2011_0131
26091008
LOINC Version 232
MTHU004883
UMLS CUI 2011AA
C0001899
SNOMED CT 2011_0131
56935002
LOINC Version 232
MTHU006766
UMLS CUI 2011AA
C1519815
UMLS CUI 2011AA
C0699792
SNOMED CT 2011_0131
263498003
UMLS CUI 2011AA
C0494165
SNOMED CT 2011_0131
94381002
MedDRA 14.1
10027457
ICD-10-CM Version 2010
C78.7
ICD-9-CM Version 2011
197.7
Serum creatinine at or > 1.5 times the upper normal limit or calculated/measured creatinine clearance at or < 60 mL/min
Description

Serum creatinine at or > 1.5 times the upper normal limit or calculated/measured creatinine clearance at or < 60 mL/min

Type de données

boolean

Alias
UMLS CUI 2011AA
C0201976
SNOMED CT 2011_0131
113075003
MedDRA 14.1
10040230
UMLS CUI 2011AA
C1519815
UMLS CUI 2011AA
C0373595
SNOMED CT 2011_0131
167181009
MedDRA 14.1
10011371
Women of child-bearing potential or men who are able to father a child unwilling to use a medically acceptable method of contraception during the trial
Description

Women of child-bearing potential or men who are able to father a child unwilling to use a medically acceptable method of contraception during the trial

Type de données

boolean

Alias
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0025266
SNOMED CT 2011_0131
339947000
UMLS CUI 2011AA
C0085732
SNOMED CT 2011_0131
371150009
UMLS CUI 2011AA
C0015671
SNOMED CT 2011_0131
66839005
LOINC Version 232
MTHU035601
HL7 V3 2006_05
FTH
UMLS CUI 2011AA
C0008059
SNOMED CT 2011_0131
67822003
HL7 V3 2006_05
CHILD
UMLS CUI 2011AA
C0558080
SNOMED CT 2011_0131
225465005
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
Pregnancy or breast feeding
Description

Pregnancy or breast feeding

Type de données

boolean

Alias
UMLS CUI 2011AA
C0032961
SNOMED CT 2011_0131
289908002
MedDRA 14.1
10036556
LOINC Version 232
MTHU035048
UMLS CUI 2011AA
C0006147
MedDRA 14.1
10006247
Patients unable to comply with the protocol
Description

Patients unable to comply with the protocol

Type de données

boolean

Alias
UMLS CUI 2011AA
C1321605
SNOMED CT 2011_0131
371151008
Patients with any serious active infection including known human immunodeficiency virus (HIV), active hepatitis B or active hepatitis C
Description

Patients with any serious active infection including known human immunodeficiency virus (HIV), active hepatitis B or active hepatitis C

Type de données

boolean

Alias
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C0205404
SNOMED CT 2011_0131
42745003
UMLS CUI 2011AA
C0009450
SNOMED CT 2011_0131
257551009
MedDRA 14.1
10021789
UMLS CUI 2011AA
C0019682
SNOMED CT 2011_0131
19030005
UMLS CUI 2011AA
C0019163
SNOMED CT 2011_0131
66071002
MedDRA 14.1
10019731
UMLS CUI 2011AA
C0019196
SNOMED CT 2011_0131
50711007
MedDRA 14.1
10019744
ICD-10-CM Version 2010
B19.20
ICD-9-CM Version 2011
070.7
Known or suspected active drug or alcohol abuse
Description

Known or suspected active drug or alcohol abuse

Type de données

boolean

Alias
UMLS CUI 2011AA
C0237123
interstitielle Lungenerkrankung
Description

Interstitial lung disease (ILD)

Type de données

boolean

Alias
UMLS CUI 2011AA
C1869044
MedDRA 14.1
20000042
Peripheral polyneuropathy Grade >= 2
Description

Peripheral polyneuropathy Grade >= 2

Type de données

boolean

Alias
UMLS CUI 2011AA
C2673754
UMLS CUI 2011AA
C0441800
SNOMED CT 2011_0131
258349007
LOINC Version 232
MTHU003112
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Similar models

Eligibility

1 Formulaires
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Einschlusskriterien
CL425202 (UMLS CUI 2011AA)
age at least 18 Years
Item
Alter mindestens 18 Jahre
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Patients with pathologically confirmed diagnosis of NSCLC Stage IIIB (with cytologically proven pleural effusion or pericardial effusion) or Stage IV who have failed treatment with erlotinib (Tarceva) or gefitinib (Iressa).
Item
Patients with pathologically confirmed diagnosis of NSCLC Stage IIIB (with cytologically proven pleural effusion or pericardial effusion) or Stage IV who have failed treatment with erlotinib (Tarceva) or gefitinib (Iressa).
boolean
C1521733 (UMLS CUI 2011AA)
29458008 (SNOMED CT 2011_0131)
C0750484 (UMLS CUI 2011AA)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0278984 (UMLS CUI 2011AA)
10029521 (MedDRA 14.1)
C0032227 (UMLS CUI 2011AA)
60046008 (SNOMED CT 2011_0131)
10035598 (MedDRA 14.1)
J90 (ICD-10-CM Version 2010)
511.9 (ICD-9-CM Version 2011)
E13486 (CTCAE 1105E)
C0031039 (UMLS CUI 2011AA)
373945007 (SNOMED CT 2011_0131)
10034474 (MedDRA 14.1)
E10172 (CTCAE 1105E)
C0278987 (UMLS CUI 2011AA)
10025055 (MedDRA 14.1)
C0162643 (UMLS CUI 2011AA)
10066901 (MedDRA 14.1)
C1135135 (UMLS CUI 2011AA)
414122006 (SNOMED CT 2011_0131)
C0910101 (UMLS CUI 2011AA)
426686007 (SNOMED CT 2011_0131)
C1122962 (UMLS CUI 2011AA)
398685009 (SNOMED CT 2011_0131)
Patients should have received and failed at least one line of cytotoxic chemotherapy including a platinum-based regimen in patients eligible for platinum-based therapy and pemetrexed in pemetrexed eligible patients (unless pemetrexed is not considered a regulatory or clinical standard of care e.g. no label indication, no availability or no coverage by 3rd party payer(s)) for advanced or metastatic disease and have progressive disease following at least 12 weeks of treatment with erlotinib or gefitinib
Item
Patients should have received and failed at least one line of cytotoxic chemotherapy including a platinum-based regimen in patients eligible for platinum-based therapy and pemetrexed in pemetrexed eligible patients (unless pemetrexed is not considered a regulatory or clinical standard of care e.g. no label indication, no availability or no coverage by 3rd party payer(s)) for advanced or metastatic disease and have progressive disease following at least 12 weeks of treatment with erlotinib or gefitinib
boolean
C0231175 (UMLS CUI 2011AA)
C0677881 (UMLS CUI 2011AA)
C0332257 (UMLS CUI 2011AA)
55919000 (SNOMED CT 2011_0131)
C1514162 (UMLS CUI 2011AA)
CL031856 (UMLS CUI 2011AA)
C0210657 (UMLS CUI 2011AA)
411089001 (SNOMED CT 2011_0131)
Patients pretreated with taxane-based chemotherapy for advanced or metastatic disease must have experienced stable disease, partial or complete response as best response
Item
Patients pretreated with taxane-based chemotherapy for advanced or metastatic disease must have experienced stable disease, partial or complete response as best response
boolean
C1514457 (UMLS CUI 2011AA)
C0215136 (UMLS CUI 2011AA)
C1705938 (UMLS CUI 2011AA)
C0679246 (UMLS CUI 2011AA)
C0027627 (UMLS CUI 2011AA)
10027478 (MedDRA 14.1)
C0027552 (UMLS CUI 2011AA)
410525008 (SNOMED CT 2011_0131)
C0677946 (UMLS CUI 2011AA)
C1521726 (UMLS CUI 2011AA)
103337004 (SNOMED CT 2011_0131)
C0677874 (UMLS CUI 2011AA)
103338009 (SNOMED CT 2011_0131)
CL426196 (UMLS CUI 2011AA)
Eastern Cooperative Oncology Group performance Score 0 or 1.
Item
Eastern Cooperative Oncology Group performance Score 0 or 1.
boolean
C1520224 (UMLS CUI 2011AA)
Patients with at least one tumor lesion that can accurately be measured by magnetic resonance imaging (MRI), or computed tomography (CT) in at least one dimension with longest diameter to be recorded as 20 mm or greater using conventional techniques or10 mm or greater with spiral CT scan according to RESIST 1.1.
Item
Patients with at least one tumor lesion that can accurately be measured by magnetic resonance imaging (MRI), or computed tomography (CT) in at least one dimension with longest diameter to be recorded as 20 mm or greater using conventional techniques or10 mm or greater with spiral CT scan according to RESIST 1.1.
boolean
CL364385 (UMLS CUI 2011AA)
C0221198 (UMLS CUI 2011AA)
49755003 (SNOMED CT 2011_0131)
C0444706 (UMLS CUI 2011AA)
258104002 (SNOMED CT 2011_0131)
C0024485 (UMLS CUI 2011AA)
113091000 (SNOMED CT 2011_0131)
10028049 (MedDRA 14.1)
C0040405 (UMLS CUI 2011AA)
77477000 (SNOMED CT 2011_0131)
10010234 (MedDRA 14.1)
0002 (HL7 V3 2006_05)
C0860888 (UMLS CUI 2011AA)
116152004 (SNOMED CT 2011_0131)
10041623 (MedDRA 14.1)
C0332290 (UMLS CUI 2011AA)
385433004 (SNOMED CT 2011_0131)
C1709926 (UMLS CUI 2011AA)
Life expectancy of >= three (3) months.
Item
Life expectancy of >= three (3) months.
boolean
C0023671 (UMLS CUI 2011AA)
LP75025-4 (LOINC Version 232)
C0439091 (UMLS CUI 2011AA)
276138003 (SNOMED CT 2011_0131)
GE (HL7 V3 2006_05)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
Written informed consent that is consistent with ICH-GCP guidelines. Part B 1) Clinical benefit (disease stabilization or antitumor response) of 12 weeks duration in Part A of the trial determined on the second tumour assessment.
Item
Written informed consent that is consistent with ICH-GCP guidelines. Part B 1) Clinical benefit (disease stabilization or antitumor response) of 12 weeks duration in Part A of the trial determined on the second tumour assessment.
boolean
C0021430 (UMLS CUI 2011AA)
Item Group
Ausschlusskriterien
CL425201 (UMLS CUI 2011AA)
Chemo-, hormone- (other than megestrol acetate, steroids required for maintenance non-cancer therapy or as premedication before chemotherapy) or immunotherapy within the past 4 weeks; except for TKI pretreatment (2 weeks only)
Item
Chemo-, hormone- (other than megestrol acetate, steroids required for maintenance non-cancer therapy or as premedication before chemotherapy) or immunotherapy within the past 4 weeks; except for TKI pretreatment (2 weeks only)
boolean
C0392920 (UMLS CUI 2011AA)
150415003 (SNOMED CT 2011_0131)
C0279025 (UMLS CUI 2011AA)
309542002, 169413002 (SNOMED CT 2011_0131)
10065646 (MedDRA 14.1)
CL411789 (UMLS CUI 2011AA)
C0065879 (UMLS CUI 2011AA)
90357001 (SNOMED CT 2011_0131)
MTHU018761 (LOINC Version 232)
C0038317 (UMLS CUI 2011AA)
116566001 (SNOMED CT 2011_0131)
C0021083 (UMLS CUI 2011AA)
146638005 (SNOMED CT 2011_0131)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C1268567 (UMLS CUI 2011AA)
372917005 (SNOMED CT 2011_0131)
C1882440 (UMLS CUI 2011AA)
Active brain metastases (stable <4 weeks, symptomatic, requiring treatment with anticonvulsants, or leptomeningeal disease). Dexamethasone therapy will be allowed if administered as a stable dose for at least one month before randomization.
Item
Active brain metastases (stable <4 weeks, symptomatic, requiring treatment with anticonvulsants, or leptomeningeal disease). Dexamethasone therapy will be allowed if administered as a stable dose for at least one month before randomization.
boolean
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0220650 (UMLS CUI 2011AA)
10006128 (MedDRA 14.1)
C1514873 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C0003299 (UMLS CUI 2011AA)
255632006 (SNOMED CT 2011_0131)
MTHU006781 (LOINC Version 232)
CL428853 (UMLS CUI 2011AA)
10070973 (MedDRA 14.1)
Significant or recent acute gastrointestinal disorders with diarrhea as a major symptom e.g., Crohn's disease, mal-absorption, or CTCAE Grade >2 diarrhea of any etiology at baseline
Item
Significant or recent acute gastrointestinal disorders with diarrhea as a major symptom e.g., Crohn's disease, mal-absorption, or CTCAE Grade >2 diarrhea of any etiology at baseline
boolean
C0205178 (UMLS CUI 2011AA)
272118002 (SNOMED CT 2011_0131)
C0017178 (UMLS CUI 2011AA)
119292006 (SNOMED CT 2011_0131)
10017944 (MedDRA 14.1)
C0011991 (UMLS CUI 2011AA)
62315008 (SNOMED CT 2011_0131)
10012735 (MedDRA 14.1)
MTHU013347 (LOINC Version 232)
R19.7 (ICD-10-CM Version 2010)
787.91 (ICD-9-CM Version 2011)
E10572 (CTCAE 1105E)
C0010346 (UMLS CUI 2011AA)
34000006 (SNOMED CT 2011_0131)
10011401 (MedDRA 14.1)
K50.9 (ICD-10-CM Version 2010)
C0024523 (UMLS CUI 2011AA)
155841000 (SNOMED CT 2011_0131)
K90.4 (ICD-10-CM Version 2010)
C1559310 (UMLS CUI 2011AA)
MTHU114261 (CTCAE 1105E)
C1559311 (UMLS CUI 2011AA)
MTHU115273 (CTCAE 1105E)
C1559312 (UMLS CUI 2011AA)
MTHU116177 (CTCAE 1105E)
Patients who have any other life-threatening illness or organ system dysfunction, which in the opinion of the Investigator, would either compromise patient safety or interfere with the evaluation of the safety of the test drug
Item
Patients who have any other life-threatening illness or organ system dysfunction, which in the opinion of the Investigator, would either compromise patient safety or interfere with the evaluation of the safety of the test drug
boolean
C2826244 (UMLS CUI 2011AA)
C0221423 (UMLS CUI 2011AA)
39104002 (SNOMED CT 2011_0131)
10040658 (MedDRA 14.1)
R69 (ICD-10-CM Version 2010)
C0460002 (UMLS CUI 2011AA)
91689009 (SNOMED CT 2011_0131)
C0277785 (UMLS CUI 2011AA)
386585008 (SNOMED CT 2011_0131)
C0221099 (UMLS CUI 2011AA)
260379002 (SNOMED CT 2011_0131)
C1113679 (UMLS CUI 2011AA)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C0013175 (UMLS CUI 2011AA)
185922005 (SNOMED CT 2011_0131)
Other malignancies diagnosed within the past five (5) years (other than non-melanomatous skin cancer and in situ cervical cancer)
Item
Other malignancies diagnosed within the past five (5) years (other than non-melanomatous skin cancer and in situ cervical cancer)
boolean
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
CL411789 (UMLS CUI 2011AA)
C0699893 (UMLS CUI 2011AA)
10040810 (MedDRA 14.1)
C0851140 (UMLS CUI 2011AA)
92564006 (SNOMED CT 2011_0131)
10061809 (MedDRA 14.1)
D06.9 (ICD-10-CM Version 2010)
233.1 (ICD-9-CM Version 2011)
Radiotherapy within the past 2 weeks prior to treatment with the trial drug
Item
Radiotherapy within the past 2 weeks prior to treatment with the trial drug
boolean
C0034619 (UMLS CUI 2011AA)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)
History of clinically significant or uncontrolled cardiac disease, including congestive heart failure, angina, myocardial infarction, arrhythmia, including New York Heart Association (NYHA) functional classification of 3
Item
History of clinically significant or uncontrolled cardiac disease, including congestive heart failure, angina, myocardial infarction, arrhythmia, including New York Heart Association (NYHA) functional classification of 3
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0018799 (UMLS CUI 2011AA)
56265001 (SNOMED CT 2011_0131)
10061024 (MedDRA 14.1)
C0018802 (UMLS CUI 2011AA)
42343007 (SNOMED CT 2011_0131)
10007559 (MedDRA 14.1)
MTHU020787 (LOINC Version 232)
I50.9 (ICD-10-CM Version 2010)
428.0 (ICD-9-CM Version 2011)
C0002962 (UMLS CUI 2011AA)
194828000 (SNOMED CT 2011_0131)
10002383 (MedDRA 14.1)
I20 (ICD-10-CM Version 2010)
413 (ICD-9-CM Version 2011)
C0027051 (UMLS CUI 2011AA)
22298006 (SNOMED CT 2011_0131)
10028596 (MedDRA 14.1)
MTHU035551 (LOINC Version 232)
I21-I22 (ICD-10-CM Version 2010)
410 (ICD-9-CM Version 2011)
E10152 (CTCAE 1105E)
C0003811 (UMLS CUI 2011AA)
44808001 (SNOMED CT 2011_0131)
10003119 (MedDRA 14.1)
427.9 (ICD-9-CM Version 2011)
C1319795 (UMLS CUI 2011AA)
420913000 (SNOMED CT 2011_0131)
10064081 (MedDRA 14.1)
Cardiac left ventricular function with resting ejection fraction of < 50% measured by multigated blood pool imaging of the heart (MUGA scan) or echocardiogram
Item
Cardiac left ventricular function with resting ejection fraction of < 50% measured by multigated blood pool imaging of the heart (MUGA scan) or echocardiogram
boolean
C0428772 (UMLS CUI 2011AA)
250908004 (SNOMED CT 2011_0131)
10069170 (MedDRA 14.1)
C0017200 (UMLS CUI 2011AA)
C0521317 (UMLS CUI 2011AA)
404221001 (SNOMED CT 2011_0131)
10028211 (MedDRA 14.1)
C2243117 (UMLS CUI 2011AA)
QTc interval at or > 0.47 second
Item
QTc-Intervall
boolean
C0489625 (UMLS CUI 2011AA)
MTHU024527 (LOINC Version 232)
Prior treatment with anthracyclines with a cumulative dose of doxorubicin (or equivalent) at or > 400 mg/m2
Item
Prior treatment with anthracyclines with a cumulative dose of doxorubicin (or equivalent) at or > 400 mg/m2
boolean
C1514463 (UMLS CUI 2011AA)
C0282564 (UMLS CUI 2011AA)
372540003 (SNOMED CT 2011_0131)
CL426125 (UMLS CUI 2011AA)
C0013089 (UMLS CUI 2011AA)
68444001 (SNOMED CT 2011_0131)
MTHU004184 (LOINC Version 232)
CL415123 (UMLS CUI 2011AA)
Absolute neutrophil count (ANC) at or < 1500 / mm3
Item
Absolute Neutrophil Count
boolean
C0948762 (UMLS CUI 2011AA)
10052033 (MedDRA 14.1)
Platelet count at or < 100,000 / mm3
Item
Thrombozyten
boolean
C1287267 (UMLS CUI 2011AA)
365632008 (SNOMED CT 2011_0131)
777-3 (LOINC Version 232)
Bilirubin at or > 1.5 mg / dL (>26 mol / L, SI unit equivalent)
Item
Bilirubin at or > 1.5 mg / dL (>26 mol / L, SI unit equivalent)
boolean
C0011221 (UMLS CUI 2011AA)
79706000 (SNOMED CT 2011_0131)
1975-2 (LOINC Version 232)
C1705302 (UMLS CUI 2011AA)
CL415123 (UMLS CUI 2011AA)
Aspartate amino transferase (AST) or alanine amino transferase (ALT) at or > three times the upper limit of normal (if related to liver metastases at or > five times the upper limit of normal)
Item
Aspartate amino transferase (AST) or alanine amino transferase (ALT) at or > three times the upper limit of normal (if related to liver metastases at or > five times the upper limit of normal)
boolean
C0004002 (UMLS CUI 2011AA)
26091008 (SNOMED CT 2011_0131)
MTHU004883 (LOINC Version 232)
C0001899 (UMLS CUI 2011AA)
56935002 (SNOMED CT 2011_0131)
MTHU006766 (LOINC Version 232)
C1519815 (UMLS CUI 2011AA)
C0699792 (UMLS CUI 2011AA)
263498003 (SNOMED CT 2011_0131)
C0494165 (UMLS CUI 2011AA)
94381002 (SNOMED CT 2011_0131)
10027457 (MedDRA 14.1)
C78.7 (ICD-10-CM Version 2010)
197.7 (ICD-9-CM Version 2011)
Serum creatinine at or > 1.5 times the upper normal limit or calculated/measured creatinine clearance at or < 60 mL/min
Item
Serum creatinine at or > 1.5 times the upper normal limit or calculated/measured creatinine clearance at or < 60 mL/min
boolean
C0201976 (UMLS CUI 2011AA)
113075003 (SNOMED CT 2011_0131)
10040230 (MedDRA 14.1)
C1519815 (UMLS CUI 2011AA)
C0373595 (UMLS CUI 2011AA)
167181009 (SNOMED CT 2011_0131)
10011371 (MedDRA 14.1)
Women of child-bearing potential or men who are able to father a child unwilling to use a medically acceptable method of contraception during the trial
Item
Women of child-bearing potential or men who are able to father a child unwilling to use a medically acceptable method of contraception during the trial
boolean
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0025266 (UMLS CUI 2011AA)
339947000 (SNOMED CT 2011_0131)
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0015671 (UMLS CUI 2011AA)
66839005 (SNOMED CT 2011_0131)
MTHU035601 (LOINC Version 232)
FTH (HL7 V3 2006_05)
C0008059 (UMLS CUI 2011AA)
67822003 (SNOMED CT 2011_0131)
CHILD (HL7 V3 2006_05)
C0558080 (UMLS CUI 2011AA)
225465005 (SNOMED CT 2011_0131)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
Pregnancy or breast feeding
Item
Pregnancy or breast feeding
boolean
C0032961 (UMLS CUI 2011AA)
289908002 (SNOMED CT 2011_0131)
10036556 (MedDRA 14.1)
MTHU035048 (LOINC Version 232)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
Patients unable to comply with the protocol
Item
Patients unable to comply with the protocol
boolean
C1321605 (UMLS CUI 2011AA)
371151008 (SNOMED CT 2011_0131)
Patients with any serious active infection including known human immunodeficiency virus (HIV), active hepatitis B or active hepatitis C
Item
Patients with any serious active infection including known human immunodeficiency virus (HIV), active hepatitis B or active hepatitis C
boolean
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0205404 (UMLS CUI 2011AA)
42745003 (SNOMED CT 2011_0131)
C0009450 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C0019682 (UMLS CUI 2011AA)
19030005 (SNOMED CT 2011_0131)
C0019163 (UMLS CUI 2011AA)
66071002 (SNOMED CT 2011_0131)
10019731 (MedDRA 14.1)
C0019196 (UMLS CUI 2011AA)
50711007 (SNOMED CT 2011_0131)
10019744 (MedDRA 14.1)
B19.20 (ICD-10-CM Version 2010)
070.7 (ICD-9-CM Version 2011)
Known or suspected active drug or alcohol abuse
Item
Known or suspected active drug or alcohol abuse
boolean
C0237123 (UMLS CUI 2011AA)
Interstitial lung disease (ILD)
Item
interstitielle Lungenerkrankung
boolean
C1869044 (UMLS CUI 2011AA)
20000042 (MedDRA 14.1)
Peripheral polyneuropathy Grade >= 2
Item
Peripheral polyneuropathy Grade >= 2
boolean
C2673754 (UMLS CUI 2011AA)
C0441800 (UMLS CUI 2011AA)
258349007 (SNOMED CT 2011_0131)
MTHU003112 (LOINC Version 232)
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