ID

30655

Beskrivning

Panitumumab DDI Irinotecan; ODM derived from: https://clinicaltrials.gov/show/NCT00563316

Länk

https://clinicaltrials.gov/show/NCT00563316

Nyckelord

Versioner (1)
  1. 2018-06-19 2018-06-19 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

19 juni 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Metastatic Colorectal Cancer NCT00563316

Engelsk

Eligibility Metastatic Colorectal Cancer NCT00563316

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
pathologically confirmed unresectable mcrc which has progressed on at least one prior 5-fluorouracil (5fu)-containing chemotherapy regimen
Beskrivning

Colorectal cancer metastatic unresectable | Disease Progression | Chemotherapy Regimen Quantity | Fluorouracil

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0948380
UMLS CUI [1,2]
C1519810
UMLS CUI [2]
C0242656
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C1265611
UMLS CUI [4]
C0016360
eastern cooperative oncology group (ecog) performance status of 0, 1, or 2
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy of >/= 3 months as documented by the investigator
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
baseline actual body weight </=160 kg
Beskrivning

Body Weight

Datatyp

boolean

Alias
UMLS CUI [1]
C0005910
competent to comprehend, sign, and date a written iec/irb approved informed consent form before any study-specific procedures are performed
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
treatment with radiotherapy </= 14 days before enrollment. patients must have recovered from all radiotherapy-related toxicities
Beskrivning

Therapeutic radiology procedure

Datatyp

boolean

Alias
UMLS CUI [1]
C1522449
known presence of central nervous systems (cns) metastases
Beskrivning

CNS metastases

Datatyp

boolean

Alias
UMLS CUI [1]
C0686377
any prior malignancy (except for non-melanomatous skin cancer or in situ cervical cancer) other than the study disease, unless treated with curative intent with no evidence of disease </= 2 years before enrollment
Beskrivning

Cancer Other | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Disease Free of

Datatyp

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]
C0851140
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0012634
UMLS CUI [4,3]
C0332296
history of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest ct scan
Beskrivning

Lung Diseases, Interstitial | Pneumonitis | Pulmonary Fibrosis | Interstitial Lung Disease Chest CT

Datatyp

boolean

Alias
UMLS CUI [1]
C0206062
UMLS CUI [2]
C3714636
UMLS CUI [3]
C0034069
UMLS CUI [4,1]
C0206062
UMLS CUI [4,2]
C0202823
active inflammatory bowel disease or other bowel disease causing chronic diarrhea (defined as > ctc grade 2 [ctcae version 3])
Beskrivning

Inflammatory Bowel Diseases | Intestinal Diseases Causing Chronic diarrhea | Intestinal Diseases CTCAE Grades

Datatyp

boolean

Alias
UMLS CUI [1]
C0021390
UMLS CUI [2,1]
C0021831
UMLS CUI [2,2]
C0678227
UMLS CUI [2,3]
C0401151
UMLS CUI [3,1]
C0021831
UMLS CUI [3,2]
C1516728
clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) </= 1 year before enrollment
Beskrivning

Cardiovascular Disease | Myocardial Infarction | Angina, Unstable | Symptomatic congestive heart failure | Cardiac Arrhythmia Serious Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0002965
UMLS CUI [4]
C0742758
UMLS CUI [5,1]
C0003811
UMLS CUI [5,2]
C0205404
UMLS CUI [5,3]
C0205318
ugt1a1*28 ta7/7, ta7/8, ta8/8 genetic polymorphisms; gilbert's disease
Beskrivning

UGT1A1*28 Allele Genetic Polymorphism | Gilbert Disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2825127
UMLS CUI [1,2]
C0032529
UMLS CUI [2]
C0017551
treatment with cyp3a4 enzyme inhibiting or inducing medications </= 2 weeks before enrollment
Beskrivning

CYP3A4 Inhibitors | CYP3A4 Inducer

Datatyp

boolean

Alias
UMLS CUI [1]
C3850053
UMLS CUI [2]
C3830625
prior anti-egfr antibody therapy (eg, cetuximab) or treatment with small molecule egfr inhibitors (eg, gefitinib, erlotinib, lapatinib)
Beskrivning

Anti-egfr monoclonal antibody therapy | cetuximab | Small Molecule EGFR inhibitor | gefitinib | erlotinib | lapatinib

Datatyp

boolean

Alias
UMLS CUI [1]
C4316122
UMLS CUI [2]
C0995188
UMLS CUI [3,1]
C1328819
UMLS CUI [3,2]
C1443775
UMLS CUI [4]
C1122962
UMLS CUI [5]
C1135135
UMLS CUI [6]
C1506770
systemic chemotherapy, hormonal therapy, immunotherapy, or experimental or approved proteins/antibodies (eg, bevacizumab) </= 30 days before enrollment
Beskrivning

Systemic Chemotherapy | Hormone Therapy | Immunotherapy | Proteins Investigational | Antibodies Investigational | Proteins Approved | Antibodies Approved | Bevacizumab

Datatyp

boolean

Alias
UMLS CUI [1]
C1883256
UMLS CUI [2]
C0279025
UMLS CUI [3]
C0021083
UMLS CUI [4,1]
C0033684
UMLS CUI [4,2]
C1517586
UMLS CUI [5,1]
C3495458
UMLS CUI [5,2]
C1517586
UMLS CUI [6,1]
C0033684
UMLS CUI [6,2]
C0205540
UMLS CUI [7,1]
C3495458
UMLS CUI [7,2]
C0205540
UMLS CUI [8]
C0796392
subjects requiring immunosuppressive agents (eg, methotrexate and cyclosporine), however corticosteroids are allowed
Beskrivning

Immunosuppressive Agents | Methotrexate | Cyclosporine | Adrenal Cortex Hormones allowed

Datatyp

boolean

Alias
UMLS CUI [1]
C0021081
UMLS CUI [2]
C0025677
UMLS CUI [3]
C0010592
UMLS CUI [4,1]
C0001617
UMLS CUI [4,2]
C0683607
major surgery < 28 days prior to enrollment or minor surgery (excluding catheter placement) < 14 days before enrollment
Beskrivning

Major surgery | Minor Surgical Procedures | Exception Catheter placement

Datatyp

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2]
C0038904
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0883301
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Similar models

Eligibility Metastatic Colorectal Cancer NCT00563316

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Colorectal cancer metastatic unresectable | Disease Progression | Chemotherapy Regimen Quantity | Fluorouracil
Item
pathologically confirmed unresectable mcrc which has progressed on at least one prior 5-fluorouracil (5fu)-containing chemotherapy regimen
boolean
C0948380 (UMLS CUI [1,1])
C1519810 (UMLS CUI [1,2])
C0242656 (UMLS CUI [2])
C0392920 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0016360 (UMLS CUI [4])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of 0, 1, or 2
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of >/= 3 months as documented by the investigator
boolean
C0023671 (UMLS CUI [1])
Body Weight
Item
baseline actual body weight </=160 kg
boolean
C0005910 (UMLS CUI [1])
Informed Consent
Item
competent to comprehend, sign, and date a written iec/irb approved informed consent form before any study-specific procedures are performed
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Therapeutic radiology procedure
Item
treatment with radiotherapy </= 14 days before enrollment. patients must have recovered from all radiotherapy-related toxicities
boolean
C1522449 (UMLS CUI [1])
CNS metastases
Item
known presence of central nervous systems (cns) metastases
boolean
C0686377 (UMLS CUI [1])
Cancer Other | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Disease Free of
Item
any prior malignancy (except for non-melanomatous skin cancer or in situ cervical cancer) other than the study disease, unless treated with curative intent with no evidence of disease </= 2 years before enrollment
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0012634 (UMLS CUI [4,2])
C0332296 (UMLS CUI [4,3])
Lung Diseases, Interstitial | Pneumonitis | Pulmonary Fibrosis | Interstitial Lung Disease Chest CT
Item
history of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest ct scan
boolean
C0206062 (UMLS CUI [1])
C3714636 (UMLS CUI [2])
C0034069 (UMLS CUI [3])
C0206062 (UMLS CUI [4,1])
C0202823 (UMLS CUI [4,2])
Inflammatory Bowel Diseases | Intestinal Diseases Causing Chronic diarrhea | Intestinal Diseases CTCAE Grades
Item
active inflammatory bowel disease or other bowel disease causing chronic diarrhea (defined as > ctc grade 2 [ctcae version 3])
boolean
C0021390 (UMLS CUI [1])
C0021831 (UMLS CUI [2,1])
C0678227 (UMLS CUI [2,2])
C0401151 (UMLS CUI [2,3])
C0021831 (UMLS CUI [3,1])
C1516728 (UMLS CUI [3,2])
Cardiovascular Disease | Myocardial Infarction | Angina, Unstable | Symptomatic congestive heart failure | Cardiac Arrhythmia Serious Uncontrolled
Item
clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) </= 1 year before enrollment
boolean
C0007222 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0742758 (UMLS CUI [4])
C0003811 (UMLS CUI [5,1])
C0205404 (UMLS CUI [5,2])
C0205318 (UMLS CUI [5,3])
UGT1A1*28 Allele Genetic Polymorphism | Gilbert Disease
Item
ugt1a1*28 ta7/7, ta7/8, ta8/8 genetic polymorphisms; gilbert's disease
boolean
C2825127 (UMLS CUI [1,1])
C0032529 (UMLS CUI [1,2])
C0017551 (UMLS CUI [2])
CYP3A4 Inhibitors | CYP3A4 Inducer
Item
treatment with cyp3a4 enzyme inhibiting or inducing medications </= 2 weeks before enrollment
boolean
C3850053 (UMLS CUI [1])
C3830625 (UMLS CUI [2])
Anti-egfr monoclonal antibody therapy | cetuximab | Small Molecule EGFR inhibitor | gefitinib | erlotinib | lapatinib
Item
prior anti-egfr antibody therapy (eg, cetuximab) or treatment with small molecule egfr inhibitors (eg, gefitinib, erlotinib, lapatinib)
boolean
C4316122 (UMLS CUI [1])
C0995188 (UMLS CUI [2])
C1328819 (UMLS CUI [3,1])
C1443775 (UMLS CUI [3,2])
C1122962 (UMLS CUI [4])
C1135135 (UMLS CUI [5])
C1506770 (UMLS CUI [6])
Systemic Chemotherapy | Hormone Therapy | Immunotherapy | Proteins Investigational | Antibodies Investigational | Proteins Approved | Antibodies Approved | Bevacizumab
Item
systemic chemotherapy, hormonal therapy, immunotherapy, or experimental or approved proteins/antibodies (eg, bevacizumab) </= 30 days before enrollment
boolean
C1883256 (UMLS CUI [1])
C0279025 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
C0033684 (UMLS CUI [4,1])
C1517586 (UMLS CUI [4,2])
C3495458 (UMLS CUI [5,1])
C1517586 (UMLS CUI [5,2])
C0033684 (UMLS CUI [6,1])
C0205540 (UMLS CUI [6,2])
C3495458 (UMLS CUI [7,1])
C0205540 (UMLS CUI [7,2])
C0796392 (UMLS CUI [8])
Immunosuppressive Agents | Methotrexate | Cyclosporine | Adrenal Cortex Hormones allowed
Item
subjects requiring immunosuppressive agents (eg, methotrexate and cyclosporine), however corticosteroids are allowed
boolean
C0021081 (UMLS CUI [1])
C0025677 (UMLS CUI [2])
C0010592 (UMLS CUI [3])
C0001617 (UMLS CUI [4,1])
C0683607 (UMLS CUI [4,2])
Major surgery | Minor Surgical Procedures | Exception Catheter placement
Item
major surgery < 28 days prior to enrollment or minor surgery (excluding catheter placement) < 14 days before enrollment
boolean
C0679637 (UMLS CUI [1])
C0038904 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0883301 (UMLS CUI [3,2])
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