ID

27378

Description

A Phase 2, Randomized, Double Blind, Placebo Controlled Study of AMG 386 in Combination With FOLFIRI in Subjects With Previously Treated Metastatic Colorectal Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00752570

Link

https://clinicaltrials.gov/show/NCT00752570

Keywords

Versions (1)
  1. 11/10/17 11/10/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 10, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Cancer NCT00752570

English

Eligibility Cancer NCT00752570

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Cancer NCT00752570
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed adenocarcinoma of the colon or rectum in patients who are presenting with metastatic disease
Description

Adenocarcinoma of colon | Adenocarcinoma of rectum | Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1]
C0338106
UMLS CUI [2]
C0149978
UMLS CUI [3]
C0027627
one and only one prior chemotherapy regimen for metastatic disease consisting of the combination of a fluoropyrimidine-based chemotherapy and an oxaliplatin-based chemotherapy. prior adjuvant chemotherapy used prior to the onset of metastatic disease is permitted
Description

Prior Chemotherapy Neoplasm Metastasis | fluoropyrimidine | oxaliplatin | Chemotherapy, Adjuvant

Data type

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0027627
UMLS CUI [2]
C0596581
UMLS CUI [3]
C0069717
UMLS CUI [4]
C0085533
at least one uni dimensionally measurable lesion per modified recist criteria. all sites of disease must be evaluated <= 28 days before randomization
Description

Measurable lesion Linear Quantity | Disease Site Evaluation

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0205132
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C1515974
UMLS CUI [2,3]
C1261322
radiographically documented disease progression per modified recist criteria either while receiving or <= 6 months after the last dose of prior chemotherapy regimen for metastatic disease
Description

Disease Progression Radiography | Prior Chemotherapy Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1,1]
C0242656
UMLS CUI [1,2]
C0034571
UMLS CUI [2,1]
C1514457
UMLS CUI [2,2]
C0027627
ecog performance status of 0 or 1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
man or woman >= 18 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
adequate end organ assessments by laboratory studies (hematological and chemistries)
Description

End Organ Assessment Hematology | End Organ Assessment Chemistry

Data type

boolean

Alias
UMLS CUI [1,1]
C0444930
UMLS CUI [1,2]
C0178784
UMLS CUI [1,3]
C1516048
UMLS CUI [1,4]
C0200627
UMLS CUI [2,1]
C0444930
UMLS CUI [2,2]
C0178784
UMLS CUI [2,3]
C1516048
UMLS CUI [2,4]
C0201682
life expectancy >= 3 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
exclude subjects with a history of prior malignancy, except:
Description

Malignant Neoplasms | Exception

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C1705847
malignancy treated with curative intent and with no known active disease present for >= 3 years before enrollment and felt to be at low risk for recurrence by treating physician
Description

Curative treatment Malignant Neoplasms | Disease Free of | Disease recurrence Low Risk

Data type

boolean

Alias
UMLS CUI [1,1]
C1273390
UMLS CUI [1,2]
C0006826
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0332296
UMLS CUI [3,1]
C0679254
UMLS CUI [3,2]
C3538919
adequately treated non-melanomatous skin cancer or lentigo maligna without evidence of disease
Description

Skin carcinoma Treated | Lentigo maligna Without Evidence of Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0699893
UMLS CUI [1,2]
C1522326
UMLS CUI [2,1]
C0149722
UMLS CUI [2,2]
C0332288
UMLS CUI [2,3]
C0332120
UMLS CUI [2,4]
C0012634
adequately treated cervical carcinoma in situ without evidence of disease
Description

Carcinoma in situ of uterine cervix Treated | Disease Evidence of Lacking

Data type

boolean

Alias
UMLS CUI [1,1]
C0851140
UMLS CUI [1,2]
C1522326
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0332120
UMLS CUI [2,3]
C0332268
prostatic intraepithelial neoplasia without evidence of prostate cancer
Description

Prostatic Intraepithelial Neoplasias | Prostate carcinoma Evidence of Lacking

Data type

boolean

Alias
UMLS CUI [1]
C0282612
UMLS CUI [2,1]
C0600139
UMLS CUI [2,2]
C0332120
UMLS CUI [2,3]
C0332268
prior irinotecan therapy
Description

irinotecan

Data type

boolean

Alias
UMLS CUI [1]
C0123931
systemic chemotherapy, hormonal therapy, or immunotherapy <= 21 days prior to randomization
Description

Systemic Chemotherapy | Hormone Therapy | Immunotherapy

Data type

boolean

Alias
UMLS CUI [1]
C1883256
UMLS CUI [2]
C0279025
UMLS CUI [3]
C0021083
experimental or approved proteins/antibodies (eg, bevacizumab) <= 30 days prior to randomization
Description

Proteins | Antibodies | bevacizumab

Data type

boolean

Alias
UMLS CUI [1]
C0033684
UMLS CUI [2]
C3495458
UMLS CUI [3]
C0796392
clinically significant cardiac disease within 12 months prior to randomization, including myocardial infarction, unstable angina, grade 2 or greater peripheral vascular disease, cerebrovascular accident, transient ischemic attack, congestive heart failure, or arrhythmias not controlled by outpatient medication, percutaneous transluminal coronary angioplasty/stent
Description

Heart Diseases | Myocardial Infarction | Angina, Unstable | Peripheral Vascular Diseases Grade | Cerebrovascular accident | Transient Ischemic Attack | Congestive heart failure | Cardiac Arrhythmia Uncontrolled | Percutaneous Transluminal Coronary Angioplasty | Stent

Data type

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0002965
UMLS CUI [4,1]
C0085096
UMLS CUI [4,2]
C0441800
UMLS CUI [5]
C0038454
UMLS CUI [6]
C0007787
UMLS CUI [7]
C0018802
UMLS CUI [8,1]
C0003811
UMLS CUI [8,2]
C0205318
UMLS CUI [9]
C2936173
UMLS CUI [10]
C0038257
known allergy or hypersensitivity to irinotecan, 5 fu (known dihydropyrimidine dehydrogenase deficiency) or leucovorin
Description

Hypersensitivity irinotecan | Fluorouracil allergy | Dihydropyrimidine Dehydrogenase Deficiency | LEUCOVORIN ALLERGY

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0123931
UMLS CUI [2]
C0570698
UMLS CUI [3]
C1959620
UMLS CUI [4]
C0745699
active inflammatory bowel disease or other bowel disease causing chronic diarrhea (defined as >= ctc grade 2 [ctcae version 3.0])
Description

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

Data type

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]
C0401151
UMLS CUI [3,2]
C1516728
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Similar models

Eligibility Cancer NCT00752570

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Cancer NCT00752570
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of colon | Adenocarcinoma of rectum | Neoplasm Metastasis
Item
histologically confirmed adenocarcinoma of the colon or rectum in patients who are presenting with metastatic disease
boolean
C0338106 (UMLS CUI [1])
C0149978 (UMLS CUI [2])
C0027627 (UMLS CUI [3])
Prior Chemotherapy Neoplasm Metastasis | fluoropyrimidine | oxaliplatin | Chemotherapy, Adjuvant
Item
one and only one prior chemotherapy regimen for metastatic disease consisting of the combination of a fluoropyrimidine-based chemotherapy and an oxaliplatin-based chemotherapy. prior adjuvant chemotherapy used prior to the onset of metastatic disease is permitted
boolean
C1514457 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
C0596581 (UMLS CUI [2])
C0069717 (UMLS CUI [3])
C0085533 (UMLS CUI [4])
Measurable lesion Linear Quantity | Disease Site Evaluation
Item
at least one uni dimensionally measurable lesion per modified recist criteria. all sites of disease must be evaluated <= 28 days before randomization
boolean
C1513041 (UMLS CUI [1,1])
C0205132 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C1515974 (UMLS CUI [2,2])
C1261322 (UMLS CUI [2,3])
Disease Progression Radiography | Prior Chemotherapy Neoplasm Metastasis
Item
radiographically documented disease progression per modified recist criteria either while receiving or <= 6 months after the last dose of prior chemotherapy regimen for metastatic disease
boolean
C0242656 (UMLS CUI [1,1])
C0034571 (UMLS CUI [1,2])
C1514457 (UMLS CUI [2,1])
C0027627 (UMLS CUI [2,2])
ECOG performance status
Item
ecog performance status of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Age
Item
man or woman >= 18 years of age
boolean
C0001779 (UMLS CUI [1])
End Organ Assessment Hematology | End Organ Assessment Chemistry
Item
adequate end organ assessments by laboratory studies (hematological and chemistries)
boolean
C0444930 (UMLS CUI [1,1])
C0178784 (UMLS CUI [1,2])
C1516048 (UMLS CUI [1,3])
C0200627 (UMLS CUI [1,4])
C0444930 (UMLS CUI [2,1])
C0178784 (UMLS CUI [2,2])
C1516048 (UMLS CUI [2,3])
C0201682 (UMLS CUI [2,4])
Life Expectancy
Item
life expectancy >= 3 months
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Malignant Neoplasms | Exception
Item
exclude subjects with a history of prior malignancy, except:
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2])
Curative treatment Malignant Neoplasms | Disease Free of | Disease recurrence Low Risk
Item
malignancy treated with curative intent and with no known active disease present for >= 3 years before enrollment and felt to be at low risk for recurrence by treating physician
boolean
C1273390 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C0332296 (UMLS CUI [2,2])
C0679254 (UMLS CUI [3,1])
C3538919 (UMLS CUI [3,2])
Skin carcinoma Treated | Lentigo maligna Without Evidence of Disease
Item
adequately treated non-melanomatous skin cancer or lentigo maligna without evidence of disease
boolean
C0699893 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C0149722 (UMLS CUI [2,1])
C0332288 (UMLS CUI [2,2])
C0332120 (UMLS CUI [2,3])
C0012634 (UMLS CUI [2,4])
Carcinoma in situ of uterine cervix Treated | Disease Evidence of Lacking
Item
adequately treated cervical carcinoma in situ without evidence of disease
boolean
C0851140 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C0332120 (UMLS CUI [2,2])
C0332268 (UMLS CUI [2,3])
Prostatic Intraepithelial Neoplasias | Prostate carcinoma Evidence of Lacking
Item
prostatic intraepithelial neoplasia without evidence of prostate cancer
boolean
C0282612 (UMLS CUI [1])
C0600139 (UMLS CUI [2,1])
C0332120 (UMLS CUI [2,2])
C0332268 (UMLS CUI [2,3])
irinotecan
Item
prior irinotecan therapy
boolean
C0123931 (UMLS CUI [1])
Systemic Chemotherapy | Hormone Therapy | Immunotherapy
Item
systemic chemotherapy, hormonal therapy, or immunotherapy <= 21 days prior to randomization
boolean
C1883256 (UMLS CUI [1])
C0279025 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
Proteins | Antibodies | bevacizumab
Item
experimental or approved proteins/antibodies (eg, bevacizumab) <= 30 days prior to randomization
boolean
C0033684 (UMLS CUI [1])
C3495458 (UMLS CUI [2])
C0796392 (UMLS CUI [3])
Heart Diseases | Myocardial Infarction | Angina, Unstable | Peripheral Vascular Diseases Grade | Cerebrovascular accident | Transient Ischemic Attack | Congestive heart failure | Cardiac Arrhythmia Uncontrolled | Percutaneous Transluminal Coronary Angioplasty | Stent
Item
clinically significant cardiac disease within 12 months prior to randomization, including myocardial infarction, unstable angina, grade 2 or greater peripheral vascular disease, cerebrovascular accident, transient ischemic attack, congestive heart failure, or arrhythmias not controlled by outpatient medication, percutaneous transluminal coronary angioplasty/stent
boolean
C0018799 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0085096 (UMLS CUI [4,1])
C0441800 (UMLS CUI [4,2])
C0038454 (UMLS CUI [5])
C0007787 (UMLS CUI [6])
C0018802 (UMLS CUI [7])
C0003811 (UMLS CUI [8,1])
C0205318 (UMLS CUI [8,2])
C2936173 (UMLS CUI [9])
C0038257 (UMLS CUI [10])
Hypersensitivity irinotecan | Fluorouracil allergy | Dihydropyrimidine Dehydrogenase Deficiency | LEUCOVORIN ALLERGY
Item
known allergy or hypersensitivity to irinotecan, 5 fu (known dihydropyrimidine dehydrogenase deficiency) or leucovorin
boolean
C0020517 (UMLS CUI [1,1])
C0123931 (UMLS CUI [1,2])
C0570698 (UMLS CUI [2])
C1959620 (UMLS CUI [3])
C0745699 (UMLS CUI [4])
Inflammatory Bowel Diseases | Intestinal Diseases Causing Chronic diarrhea | Chronic diarrhea CTCAE Grades
Item
active inflammatory bowel disease or other bowel disease causing chronic diarrhea (defined as >= ctc grade 2 [ctcae version 3.0])
boolean
C0021390 (UMLS CUI [1])
C0021831 (UMLS CUI [2,1])
C0678227 (UMLS CUI [2,2])
C0401151 (UMLS CUI [2,3])
C0401151 (UMLS CUI [3,1])
C1516728 (UMLS CUI [3,2])
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