ID

28237

Beschrijving

Phase I/II Study of KRN330 Plus Irinotecan in Patients With Metastatic Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00838578

Link

https://clinicaltrials.gov/show/NCT00838578

Trefwoorden

Versies (1)
  1. 29-12-17 29-12-17 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

29 december 2017

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Colorectal Cancer NCT00838578

Engels

Eligibility Colorectal Cancer NCT00838578

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
have histologically confirmed colorectal cancer that is metastatic with measurable disease.
Beschrijving

Colorectal cancer metastatic | Measurable Disease

Datatype

boolean

Alias
UMLS CUI [1]
C0948380
UMLS CUI [2]
C1513041
for the phase ii portion: have recurred or progressed within 6 months of the last cycle of folfox +/- bevacizumab first-line or adjuvant regimen for metastatic colorectal cancer. note: those who had initiated folfox/capox but stopped oxaliplatin because of intolerable toxicity are also eligible.
Beschrijving

Recurrent disease | Disease Progression | FOLFOX Regimen Cycle Last | bevacizumab | First line treatment Colorectal cancer metastatic | Adjuvant therapy Colorectal cancer metastatic | CAPOX Regimen | Oxaliplatin Discontinued | Toxicity Unacceptable

Datatype

boolean

Alias
UMLS CUI [1]
C0277556
UMLS CUI [2]
C0242656
UMLS CUI [3,1]
C0392943
UMLS CUI [3,2]
C1302181
UMLS CUI [3,3]
C1517741
UMLS CUI [4]
C0796392
UMLS CUI [5,1]
C1708063
UMLS CUI [5,2]
C0948380
UMLS CUI [6,1]
C0677850
UMLS CUI [6,2]
C0948380
UMLS CUI [7]
C1879915
UMLS CUI [8,1]
C0069717
UMLS CUI [8,2]
C1444662
UMLS CUI [9,1]
C0600688
UMLS CUI [9,2]
C1883420
at least 4 weeks have elapsed since the last chemotherapy, radiotherapy, immunotherapy, or biologic therapy prior to enrollment (except at least 6 weeks in the case of nitrosourea and mitomycin).
Beschrijving

Chemotherapy | Therapeutic radiology procedure | Immunotherapy | Biological treatment | Nitrosourea | Mitomycin

Datatype

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0021083
UMLS CUI [4]
C1531518
UMLS CUI [5]
C0028210
UMLS CUI [6]
C0002475
have not received any other investigational agents within 4 weeks of study entry and have fully recovered from any adverse event due to prior therapy.
Beschrijving

Investigational New Drugs Absent | Adverse event Due to Prior Therapy | Patient recovered

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0877248
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C1514463
UMLS CUI [3]
C1115804
at least 4 weeks have elapsed since any major surgery.
Beschrijving

Major surgery

Datatype

boolean

Alias
UMLS CUI [1]
C0679637
have ecog performance status of 0, 1, or 2.
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
have adequate bone marrow and organ function
Beschrijving

Bone Marrow function | Organ function

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0678852
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
have an active, uncontrolled infection.
Beschrijving

Communicable Disease Uncontrolled

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
have known hiv positive status.
Beschrijving

HIV Seropositivity

Datatype

boolean

Alias
UMLS CUI [1]
C0019699
have known or suspected cerebral metastasis.
Beschrijving

Cerebral metastasis | Cerebral metastasis Suspected

Datatype

boolean

Alias
UMLS CUI [1]
C0555278
UMLS CUI [2,1]
C0555278
UMLS CUI [2,2]
C0750491
have had a myocardial infarction (mi) or cerebrovascular accident (cva) within the last 6 months; or meet the criteria for aha class iii or iv congestive heart failure (chf).
Beschrijving

Myocardial Infarction | Cerebrovascular accident | Congestive heart failure AHA Classification

Datatype

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0038454
UMLS CUI [3,1]
C0018802
UMLS CUI [3,2]
C0002458
UMLS CUI [3,3]
C0008902
have a medical condition requiring chronic use of high-dose corticosteroids or other chronic immunosuppressive therapy (e.g. methotrexate, azathioprine).
Beschrijving

Medical condition Requirement Adrenal Cortex Hormones chronic | Medical condition Requirement Adrenal Cortex Hormones High dose | Medical condition Requirement Therapeutic immunosuppression chronic | Methotrexate | Azathioprine

Datatype

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0001617
UMLS CUI [1,4]
C0205191
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0001617
UMLS CUI [2,4]
C0444956
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C0021079
UMLS CUI [3,4]
C0205191
UMLS CUI [4]
C0025677
UMLS CUI [5]
C0004482
have a history of greater than or equal to grade 2 allergic reaction or hypersensitivity following exposure to humanized or human monoclonal antibodies (but not chimeric antibodies).
Beschrijving

Allergic Reaction Grade Humanized Monoclonal Antibodies | Hypersensitivity Grade Humanized Monoclonal Antibodies | Allergic Reaction Grade Monoclonal Antibodies Human | Hypersensitivity Grade Monoclonal Antibodies Human | Exception Chimeric antibody

Datatype

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0441800
UMLS CUI [1,3]
C2985546
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0441800
UMLS CUI [2,3]
C2985546
UMLS CUI [3,1]
C1527304
UMLS CUI [3,2]
C0441800
UMLS CUI [3,3]
C0003250
UMLS CUI [3,4]
C0086418
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0441800
UMLS CUI [4,3]
C0003250
UMLS CUI [4,4]
C0086418
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0598622
pregnant or breastfeeding women and male or female patients who do not agree to use effective contraceptive method(s) during the study.
Beschrijving

Pregnancy | Breast Feeding | Gender Contraceptive methods Unwilling

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0558080
Terug naar het begin van de pagina

Similar models

Eligibility Colorectal Cancer NCT00838578

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Colorectal cancer metastatic | Measurable Disease
Item
have histologically confirmed colorectal cancer that is metastatic with measurable disease.
boolean
C0948380 (UMLS CUI [1])
C1513041 (UMLS CUI [2])
Recurrent disease | Disease Progression | FOLFOX Regimen Cycle Last | bevacizumab | First line treatment Colorectal cancer metastatic | Adjuvant therapy Colorectal cancer metastatic | CAPOX Regimen | Oxaliplatin Discontinued | Toxicity Unacceptable
Item
for the phase ii portion: have recurred or progressed within 6 months of the last cycle of folfox +/- bevacizumab first-line or adjuvant regimen for metastatic colorectal cancer. note: those who had initiated folfox/capox but stopped oxaliplatin because of intolerable toxicity are also eligible.
boolean
C0277556 (UMLS CUI [1])
C0242656 (UMLS CUI [2])
C0392943 (UMLS CUI [3,1])
C1302181 (UMLS CUI [3,2])
C1517741 (UMLS CUI [3,3])
C0796392 (UMLS CUI [4])
C1708063 (UMLS CUI [5,1])
C0948380 (UMLS CUI [5,2])
C0677850 (UMLS CUI [6,1])
C0948380 (UMLS CUI [6,2])
C1879915 (UMLS CUI [7])
C0069717 (UMLS CUI [8,1])
C1444662 (UMLS CUI [8,2])
C0600688 (UMLS CUI [9,1])
C1883420 (UMLS CUI [9,2])
Chemotherapy | Therapeutic radiology procedure | Immunotherapy | Biological treatment | Nitrosourea | Mitomycin
Item
at least 4 weeks have elapsed since the last chemotherapy, radiotherapy, immunotherapy, or biologic therapy prior to enrollment (except at least 6 weeks in the case of nitrosourea and mitomycin).
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
C1531518 (UMLS CUI [4])
C0028210 (UMLS CUI [5])
C0002475 (UMLS CUI [6])
Investigational New Drugs Absent | Adverse event Due to Prior Therapy | Patient recovered
Item
have not received any other investigational agents within 4 weeks of study entry and have fully recovered from any adverse event due to prior therapy.
boolean
C0013230 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0877248 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C1514463 (UMLS CUI [2,3])
C1115804 (UMLS CUI [3])
Major surgery
Item
at least 4 weeks have elapsed since any major surgery.
boolean
C0679637 (UMLS CUI [1])
ECOG performance status
Item
have ecog performance status of 0, 1, or 2.
boolean
C1520224 (UMLS CUI [1])
Bone Marrow function | Organ function
Item
have adequate bone marrow and organ function
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0678852 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Communicable Disease Uncontrolled
Item
have an active, uncontrolled infection.
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
HIV Seropositivity
Item
have known hiv positive status.
boolean
C0019699 (UMLS CUI [1])
Cerebral metastasis | Cerebral metastasis Suspected
Item
have known or suspected cerebral metastasis.
boolean
C0555278 (UMLS CUI [1])
C0555278 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
Myocardial Infarction | Cerebrovascular accident | Congestive heart failure AHA Classification
Item
have had a myocardial infarction (mi) or cerebrovascular accident (cva) within the last 6 months; or meet the criteria for aha class iii or iv congestive heart failure (chf).
boolean
C0027051 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0018802 (UMLS CUI [3,1])
C0002458 (UMLS CUI [3,2])
C0008902 (UMLS CUI [3,3])
Medical condition Requirement Adrenal Cortex Hormones chronic | Medical condition Requirement Adrenal Cortex Hormones High dose | Medical condition Requirement Therapeutic immunosuppression chronic | Methotrexate | Azathioprine
Item
have a medical condition requiring chronic use of high-dose corticosteroids or other chronic immunosuppressive therapy (e.g. methotrexate, azathioprine).
boolean
C3843040 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0001617 (UMLS CUI [1,3])
C0205191 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0001617 (UMLS CUI [2,3])
C0444956 (UMLS CUI [2,4])
C3843040 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0021079 (UMLS CUI [3,3])
C0205191 (UMLS CUI [3,4])
C0025677 (UMLS CUI [4])
C0004482 (UMLS CUI [5])
Allergic Reaction Grade Humanized Monoclonal Antibodies | Hypersensitivity Grade Humanized Monoclonal Antibodies | Allergic Reaction Grade Monoclonal Antibodies Human | Hypersensitivity Grade Monoclonal Antibodies Human | Exception Chimeric antibody
Item
have a history of greater than or equal to grade 2 allergic reaction or hypersensitivity following exposure to humanized or human monoclonal antibodies (but not chimeric antibodies).
boolean
C1527304 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C2985546 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0441800 (UMLS CUI [2,2])
C2985546 (UMLS CUI [2,3])
C1527304 (UMLS CUI [3,1])
C0441800 (UMLS CUI [3,2])
C0003250 (UMLS CUI [3,3])
C0086418 (UMLS CUI [3,4])
C0020517 (UMLS CUI [4,1])
C0441800 (UMLS CUI [4,2])
C0003250 (UMLS CUI [4,3])
C0086418 (UMLS CUI [4,4])
C1705847 (UMLS CUI [5,1])
C0598622 (UMLS CUI [5,2])
Pregnancy | Breast Feeding | Gender Contraceptive methods Unwilling
Item
pregnant or breastfeeding women and male or female patients who do not agree to use effective contraceptive method(s) during the study.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0558080 (UMLS CUI [3,3])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial