ID

28237

Beschreibung

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

Stichworte

Versionen (1)
  1. 29.12.17 29.12.17 -
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See clinicaltrials.gov

Hochgeladen am

29. Dezember 2017

DOI

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Eligibility Colorectal Cancer NCT00838578

Englisch

Eligibility Colorectal Cancer NCT00838578

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Colorectal cancer metastatic | Measurable Disease

Datentyp

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.
Beschreibung

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

Datentyp

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).
Beschreibung

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

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Major surgery

Datentyp

boolean

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

ECOG performance status

Datentyp

boolean

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

Bone Marrow function | Organ function

Datentyp

boolean

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

Exclusion Criteria

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

Communicable Disease Uncontrolled

Datentyp

boolean

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

HIV Seropositivity

Datentyp

boolean

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

Cerebral metastasis | Cerebral metastasis Suspected

Datentyp

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).
Beschreibung

Myocardial Infarction | Cerebrovascular accident | Congestive heart failure AHA Classification

Datentyp

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).
Beschreibung

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

Datentyp

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).
Beschreibung

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

Datentyp

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.
Beschreibung

Pregnancy | Breast Feeding | Gender Contraceptive methods Unwilling

Datentyp

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
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Ähnliche Modelle

Eligibility Colorectal Cancer NCT00838578

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
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