ID

28321

Description

A Phase II Trial of MB-6 Plus FOLFOX4 for Metastatic Colorectal Cancer (FDA IND 103675); ODM derived from: https://clinicaltrials.gov/show/NCT01047475

Link

https://clinicaltrials.gov/show/NCT01047475

Keywords

Versions (1)
  1. 1/4/18 1/4/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 4, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Colorectal Cancer NCT01047475

English

Eligibility Colorectal Cancer NCT01047475

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patient with histologically confirmed colorectal cancer and/or clinical evidence of metastasis;
Description

Colorectal Carcinoma | Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1]
C0009402
UMLS CUI [2]
C0027627
2. at least one measurable lesion either by computer tomography (ct) scan or magnetic resonance imaging (mri);
Description

Measurable lesion Quantity CT scan | Measurable lesion Quantity MRI

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0040405
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0024485
3. aged 20 years old or above;
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
4. eastern cooperative oncology group (ecog) performance status < 2;
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
5. adequate bone marrow reserve (hemoglobin > 9 g/dl, absolute neutrophil count > 1.5 x 109/l, platelets > 100 x 109/l);
Description

Mature Neutrophils Present Bone Marrow | Hemoglobin measurement | Absolute neutrophil count | Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C1708947
UMLS CUI [1,2]
C0005953
UMLS CUI [2]
C0518015
UMLS CUI [3]
C0948762
UMLS CUI [4]
C0032181
6. adequate renal and hepatic functions: total bilirubin < 1.25 x upper normal limit, creatinine < 1.25 x upper normal limit, alanine aminotransferase (alt) or aspartate aminotransferase (ast) < 2.5 x upper normal limit;
Description

Renal function | Liver function | Serum total bilirubin measurement | Creatinine measurement, serum | Alanine aminotransferase measurement | Aspartate aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0232741
UMLS CUI [3]
C1278039
UMLS CUI [4]
C0201976
UMLS CUI [5]
C0201836
UMLS CUI [6]
C0201899
7. patients willing to participate in the trial and giving written informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. pregnant or lactating patients;
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
2. patients (male or female) with reproductive potential not using adequate contraceptive measures;
Description

Fertility Contraceptive methods Lacking

Data type

boolean

Alias
UMLS CUI [1,1]
C0015895
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332268
3. patients with evidence of central nervous system metastasis;
Description

CNS metastases

Data type

boolean

Alias
UMLS CUI [1]
C0686377
4. subject with active infection which requires systemic treatment of antibiotic, antifungal, or antiviral agents
Description

Communicable Disease Requirement Systemic therapy | Antibiotics | Antifungal Agents | Antiviral Agents

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C1515119
UMLS CUI [2]
C0003232
UMLS CUI [3]
C0003308
UMLS CUI [4]
C0003451
5. current history of chronic diarrhea;
Description

Chronic diarrhea

Data type

boolean

Alias
UMLS CUI [1]
C0401151
6. other serious illness or medical conditions (e.g.: history of angina, myocardial infarction);
Description

Illness Serious | Medical condition Serious | Angina Pectoris | Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0205404
UMLS CUI [3]
C0002962
UMLS CUI [4]
C0027051
7. history of second primary malignancies except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix;
Description

Second Primary Cancers | Exception Basal cell carcinoma Treated | Exception Carcinoma in situ of uterine cervix Treated

Data type

boolean

Alias
UMLS CUI [1]
C0751623
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
UMLS CUI [3,3]
C1522326
8. concurrent treatment with any other anticancer therapy;
Description

Cancer treatment Other

Data type

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205394
9. patients with congestive heart failure (new york heart association functional classification iii or iv), epilepsy, or other significant medical conditions as judged by the investigator;
Description

Congestive heart failure New York Heart Association Classification | Epilepsy | Other medical condition Significant

Data type

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
UMLS CUI [2]
C0014544
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0750502
10. patients treated with another investigational drug within 4 weeks of entry into this study.
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
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Similar models

Eligibility Colorectal Cancer NCT01047475

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Colorectal Carcinoma | Neoplasm Metastasis
Item
1. patient with histologically confirmed colorectal cancer and/or clinical evidence of metastasis;
boolean
C0009402 (UMLS CUI [1])
C0027627 (UMLS CUI [2])
Measurable lesion Quantity CT scan | Measurable lesion Quantity MRI
Item
2. at least one measurable lesion either by computer tomography (ct) scan or magnetic resonance imaging (mri);
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0040405 (UMLS CUI [1,3])
C1513041 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0024485 (UMLS CUI [2,3])
Age
Item
3. aged 20 years old or above;
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
4. eastern cooperative oncology group (ecog) performance status < 2;
boolean
C1520224 (UMLS CUI [1])
Mature Neutrophils Present Bone Marrow | Hemoglobin measurement | Absolute neutrophil count | Platelet Count measurement
Item
5. adequate bone marrow reserve (hemoglobin > 9 g/dl, absolute neutrophil count > 1.5 x 109/l, platelets > 100 x 109/l);
boolean
C1708947 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0518015 (UMLS CUI [2])
C0948762 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
Renal function | Liver function | Serum total bilirubin measurement | Creatinine measurement, serum | Alanine aminotransferase measurement | Aspartate aminotransferase measurement
Item
6. adequate renal and hepatic functions: total bilirubin < 1.25 x upper normal limit, creatinine < 1.25 x upper normal limit, alanine aminotransferase (alt) or aspartate aminotransferase (ast) < 2.5 x upper normal limit;
boolean
C0232804 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
C0201976 (UMLS CUI [4])
C0201836 (UMLS CUI [5])
C0201899 (UMLS CUI [6])
Informed Consent
Item
7. patients willing to participate in the trial and giving written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
1. pregnant or lactating patients;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Fertility Contraceptive methods Lacking
Item
2. patients (male or female) with reproductive potential not using adequate contraceptive measures;
boolean
C0015895 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
CNS metastases
Item
3. patients with evidence of central nervous system metastasis;
boolean
C0686377 (UMLS CUI [1])
Communicable Disease Requirement Systemic therapy | Antibiotics | Antifungal Agents | Antiviral Agents
Item
4. subject with active infection which requires systemic treatment of antibiotic, antifungal, or antiviral agents
boolean
C0009450 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C1515119 (UMLS CUI [1,3])
C0003232 (UMLS CUI [2])
C0003308 (UMLS CUI [3])
C0003451 (UMLS CUI [4])
Chronic diarrhea
Item
5. current history of chronic diarrhea;
boolean
C0401151 (UMLS CUI [1])
Illness Serious | Medical condition Serious | Angina Pectoris | Myocardial Infarction
Item
6. other serious illness or medical conditions (e.g.: history of angina, myocardial infarction);
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C3843040 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0002962 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
Second Primary Cancers | Exception Basal cell carcinoma Treated | Exception Carcinoma in situ of uterine cervix Treated
Item
7. history of second primary malignancies except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix;
boolean
C0751623 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
Cancer treatment Other
Item
8. concurrent treatment with any other anticancer therapy;
boolean
C0920425 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Congestive heart failure New York Heart Association Classification | Epilepsy | Other medical condition Significant
Item
9. patients with congestive heart failure (new york heart association functional classification iii or iv), epilepsy, or other significant medical conditions as judged by the investigator;
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0014544 (UMLS CUI [2])
C3843040 (UMLS CUI [3,1])
C0750502 (UMLS CUI [3,2])
Investigational New Drugs
Item
10. patients treated with another investigational drug within 4 weeks of entry into this study.
boolean
C0013230 (UMLS CUI [1])
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