ID

30658

Description

Phase 1b/2 Study of AMG 655 With mFOLFOX6 and Bevacizumab for First-Line Metastatic Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00625651

Lien

https://clinicaltrials.gov/show/NCT00625651

Mots-clés

  1. 19/06/2018 19/06/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

19 juin 2018

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

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Eligibility Metastatic Colorectal Cancer NCT00625651

Eligibility Metastatic Colorectal Cancer NCT00625651

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum.
Description

Adenocarcinoma of colon metastatic | Adenocarcinoma of rectum metastatic

Type de données

boolean

Alias
UMLS CUI [1]
C4324497
UMLS CUI [2,1]
C0149978
UMLS CUI [2,2]
C1522484
subjects with measurable or unmeasurable disease
Description

Measurable Disease | Non-Measurable Lesion

Type de données

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C1334988
eastern cooperative oncology group (ecog) score of 0 or 1
Description

ECOG performance status

Type de données

boolean

Alias
UMLS CUI [1]
C1520224
men or women at least 18 years of age
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
adequate hematologic, renal, hepatic and coagulation function
Description

Hematologic function | Renal function | Liver function | Coagulation function analysis

Type de données

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
UMLS CUI [4]
C3516400
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history or known presence of central nervous system (cns) metastases
Description

CNS metastases

Type de données

boolean

Alias
UMLS CUI [1]
C0686377
prior chemotherapy or other systemic therapy for advanced or metastatic crc
Description

Prior Chemotherapy Colorectal Carcinoma Advanced | Systemic therapy Colorectal Carcinoma Advanced | Prior Chemotherapy Colorectal Carcinoma metastatic | Systemic therapy Colorectal Carcinoma metastatic

Type de données

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0009402
UMLS CUI [1,3]
C0205179
UMLS CUI [2,1]
C1515119
UMLS CUI [2,2]
C0009402
UMLS CUI [2,3]
C0205179
UMLS CUI [3,1]
C1514457
UMLS CUI [3,2]
C0009402
UMLS CUI [3,3]
C1522484
UMLS CUI [4,1]
C1515119
UMLS CUI [4,2]
C0009402
UMLS CUI [4,3]
C1522484
any investigational agent or therapy for advanced or metastatic crc
Description

Investigational New Drugs Colorectal Carcinoma Advanced | Investigational New Drugs Colorectal Carcinoma metastatic | Investigational Therapy Colorectal Carcinoma Advanced | Investigational Therapy Colorectal Carcinoma metastatic

Type de données

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0009402
UMLS CUI [1,3]
C0205179
UMLS CUI [2,1]
C0013230
UMLS CUI [2,2]
C0009402
UMLS CUI [2,3]
C1522484
UMLS CUI [3,1]
C0949266
UMLS CUI [3,2]
C0009402
UMLS CUI [3,3]
C0205179
UMLS CUI [4,1]
C0949266
UMLS CUI [4,2]
C0009402
UMLS CUI [4,3]
C1522484
clinically significant cardiac disease
Description

Heart Disease

Type de données

boolean

Alias
UMLS CUI [1]
C0018799
clinically significant peripheral neuropathy
Description

Peripheral Neuropathy

Type de données

boolean

Alias
UMLS CUI [1]
C0031117
active inflammatory bowel disease
Description

Inflammatory Bowel Disease

Type de données

boolean

Alias
UMLS CUI [1]
C0021390
recent gastrointestinal ulcer or hemorrhage
Description

Gastrointestinal ulcer | Hemorrhage

Type de données

boolean

Alias
UMLS CUI [1]
C0237938
UMLS CUI [2]
C0019080
recent arterial thrombotic event or pulmonary embolus
Description

Arterial thrombosis | Pulmonary Embolism

Type de données

boolean

Alias
UMLS CUI [1]
C0151942
UMLS CUI [2]
C0034065
recent history of clinically significant bleeding, bleeding diathesis, or coagulopathy
Description

Hemorrhage | Bleeding tendency | Blood Coagulation Disorders

Type de données

boolean

Alias
UMLS CUI [1]
C0019080
UMLS CUI [2]
C1458140
UMLS CUI [3]
C0005779
recent major surgical procedure or not yet recovered from major surgery
Description

Major surgery | Major surgery Recovery Lacking

Type de données

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2,1]
C0679637
UMLS CUI [2,2]
C2004454
UMLS CUI [2,3]
C0332268

Similar models

Eligibility Metastatic Colorectal Cancer NCT00625651

Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of colon metastatic | Adenocarcinoma of rectum metastatic
Item
histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum.
boolean
C4324497 (UMLS CUI [1])
C0149978 (UMLS CUI [2,1])
C1522484 (UMLS CUI [2,2])
Measurable Disease | Non-Measurable Lesion
Item
subjects with measurable or unmeasurable disease
boolean
C1513041 (UMLS CUI [1])
C1334988 (UMLS CUI [2])
ECOG performance status
Item
eastern cooperative oncology group (ecog) score of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Age
Item
men or women at least 18 years of age
boolean
C0001779 (UMLS CUI [1])
Hematologic function | Renal function | Liver function | Coagulation function analysis
Item
adequate hematologic, renal, hepatic and coagulation function
boolean
C0221130 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
C3516400 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
CNS metastases
Item
history or known presence of central nervous system (cns) metastases
boolean
C0686377 (UMLS CUI [1])
Prior Chemotherapy Colorectal Carcinoma Advanced | Systemic therapy Colorectal Carcinoma Advanced | Prior Chemotherapy Colorectal Carcinoma metastatic | Systemic therapy Colorectal Carcinoma metastatic
Item
prior chemotherapy or other systemic therapy for advanced or metastatic crc
boolean
C1514457 (UMLS CUI [1,1])
C0009402 (UMLS CUI [1,2])
C0205179 (UMLS CUI [1,3])
C1515119 (UMLS CUI [2,1])
C0009402 (UMLS CUI [2,2])
C0205179 (UMLS CUI [2,3])
C1514457 (UMLS CUI [3,1])
C0009402 (UMLS CUI [3,2])
C1522484 (UMLS CUI [3,3])
C1515119 (UMLS CUI [4,1])
C0009402 (UMLS CUI [4,2])
C1522484 (UMLS CUI [4,3])
Investigational New Drugs Colorectal Carcinoma Advanced | Investigational New Drugs Colorectal Carcinoma metastatic | Investigational Therapy Colorectal Carcinoma Advanced | Investigational Therapy Colorectal Carcinoma metastatic
Item
any investigational agent or therapy for advanced or metastatic crc
boolean
C0013230 (UMLS CUI [1,1])
C0009402 (UMLS CUI [1,2])
C0205179 (UMLS CUI [1,3])
C0013230 (UMLS CUI [2,1])
C0009402 (UMLS CUI [2,2])
C1522484 (UMLS CUI [2,3])
C0949266 (UMLS CUI [3,1])
C0009402 (UMLS CUI [3,2])
C0205179 (UMLS CUI [3,3])
C0949266 (UMLS CUI [4,1])
C0009402 (UMLS CUI [4,2])
C1522484 (UMLS CUI [4,3])
Heart Disease
Item
clinically significant cardiac disease
boolean
C0018799 (UMLS CUI [1])
Peripheral Neuropathy
Item
clinically significant peripheral neuropathy
boolean
C0031117 (UMLS CUI [1])
Inflammatory Bowel Disease
Item
active inflammatory bowel disease
boolean
C0021390 (UMLS CUI [1])
Gastrointestinal ulcer | Hemorrhage
Item
recent gastrointestinal ulcer or hemorrhage
boolean
C0237938 (UMLS CUI [1])
C0019080 (UMLS CUI [2])
Arterial thrombosis | Pulmonary Embolism
Item
recent arterial thrombotic event or pulmonary embolus
boolean
C0151942 (UMLS CUI [1])
C0034065 (UMLS CUI [2])
Hemorrhage | Bleeding tendency | Blood Coagulation Disorders
Item
recent history of clinically significant bleeding, bleeding diathesis, or coagulopathy
boolean
C0019080 (UMLS CUI [1])
C1458140 (UMLS CUI [2])
C0005779 (UMLS CUI [3])
Major surgery | Major surgery Recovery Lacking
Item
recent major surgical procedure or not yet recovered from major surgery
boolean
C0679637 (UMLS CUI [1])
C0679637 (UMLS CUI [2,1])
C2004454 (UMLS CUI [2,2])
C0332268 (UMLS CUI [2,3])

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