ID

30658

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT00625651

Stichworte

Versionen (1)
  1. 19.06.18 19.06.18 -
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See clinicaltrials.gov

Hochgeladen am

19. Juni 2018

DOI

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Eligibility Metastatic Colorectal Cancer NCT00625651

Englisch

Eligibility Metastatic Colorectal Cancer NCT00625651

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Adenocarcinoma of colon metastatic | Adenocarcinoma of rectum metastatic

Datentyp

boolean

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

Measurable Disease | Non-Measurable Lesion

Datentyp

boolean

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

ECOG performance status

Datentyp

boolean

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

Age

Datentyp

boolean

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

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

Datentyp

boolean

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

Exclusion Criteria

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

CNS metastases

Datentyp

boolean

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

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

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

Heart Disease

Datentyp

boolean

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

Peripheral Neuropathy

Datentyp

boolean

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

Inflammatory Bowel Disease

Datentyp

boolean

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

Gastrointestinal ulcer | Hemorrhage

Datentyp

boolean

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

Arterial thrombosis | Pulmonary Embolism

Datentyp

boolean

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

Hemorrhage | Bleeding tendency | Blood Coagulation Disorders

Datentyp

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
Beschreibung

Major surgery | Major surgery Recovery Lacking

Datentyp

boolean

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

Eligibility Metastatic Colorectal Cancer NCT00625651

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