ID

25354

Beskrivning

A Phase I/II Study of BGT226 in Adult Patients With Advanced Solid Malignancies Including Patients With Advanced Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00600275

Länk

https://clinicaltrials.gov/show/NCT00600275

Nyckelord

Versioner (1)
  1. 2017-09-02 2017-09-02 -
Uppladdad den

2 september 2017

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Solid Tumors NCT00600275

Engelsk

Eligibility Solid Tumors NCT00600275

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
all patients
Beskrivning

Patients All

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0444868
histologically-confirmed, advanced solid tumors
Beskrivning

Solid tumour Advanced

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0280100
UMLS CUI [1,2]
C0205179
progressive, recurrent unresectable disease
Beskrivning

Progressive Disease | Recurrent disease unresectable

Datatyp

boolean

Alias
UMLS CUI [1]
C1335499
UMLS CUI [2,1]
C0277556
UMLS CUI [2,2]
C1519810
phase ii expansion part (advanced breast cancer)
Beskrivning

Phase 2 Clinical Trial | Advanced breast cancer

Datatyp

boolean

Alias
UMLS CUI [1]
C0282460
UMLS CUI [2]
C3495917
confirmed positive hormone receptor (estrogen receptor and/or progesterone receptor) or positive her-2 expression status
Beskrivning

Hormone Receptor/HER2 Positive | Estrogen receptor positive | Progesterone receptor positive | HER2/Neu Positive

Datatyp

boolean

Alias
UMLS CUI [1]
C3898879
UMLS CUI [2]
C0279754
UMLS CUI [3]
C0279759
UMLS CUI [4]
C2348909
disease progression/recurrence following hormonal or anti-her-2 treatment for advanced disease
Beskrivning

Disease Progression | Recurrent disease | Hormone Therapy Advanced disease | Anti HER2 Advanced disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2]
C0277556
UMLS CUI [3,1]
C0279025
UMLS CUI [3,2]
C0679246
UMLS CUI [4,1]
C0728747
UMLS CUI [4,2]
C0679246
at least one but not more than two prior chemotherapy regimens for the unresectable tumor
Beskrivning

Chemotherapy Regimen Quantity Unresectable Malignant Neoplasm

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C1336869
measurable disease by mri or ct scan
Beskrivning

Measurable Disease MRI | Measurable Disease CT scan

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0024485
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C0040405
cowden syndrome patients with an advanced malignancy genetic confirmation of cowden syndrome
Beskrivning

Cowden Syndrome Advanced

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018553
UMLS CUI [1,2]
C0205179
age ≥ 18
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
world health organization (who) performance status of ≤ 2
Beskrivning

WHO performance status scale

Datatyp

boolean

Alias
UMLS CUI [1]
C1298650
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
hematopoietic:
Beskrivning

Hematopoietic

Datatyp

boolean

Alias
UMLS CUI [1]
C0229601
no diabetes mellitus or history of gestational diabetes mellitus
Beskrivning

Diabetes Mellitus | History of gestational diabetes mellitus

Datatyp

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2]
C2183115
no acute or chronic renal disease
Beskrivning

Kidney Diseases | Chronic Kidney Diseases

Datatyp

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C1561643
no acute or chronic liver disease
Beskrivning

Liver disease | Chronic liver disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0341439
no acute or chronic pancreatitis
Beskrivning

Pancreatitis | Pancreatitis, Chronic

Datatyp

boolean

Alias
UMLS CUI [1]
C0030305
UMLS CUI [2]
C0149521
no impaired cardiac function or clinically significant cardiac diseases such as ventricular arrhythmia, congestive heart failure, uncontrolled hypertension
Beskrivning

Decreased cardiac function | Heart Diseases | Ventricular arrhythmia | Congestive heart failure | Uncontrolled hypertension

Datatyp

boolean

Alias
UMLS CUI [1]
C0232166
UMLS CUI [2]
C0018799
UMLS CUI [3]
C0085612
UMLS CUI [4]
C0018802
UMLS CUI [5]
C1868885
no acute myocardial infarction or unstable angina pectoris within the past 3 months
Beskrivning

Myocardial Infarction | Angina, Unstable

Datatyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0002965
not pregnant or nursing and fertile patients must use barrier contraceptives
Beskrivning

Pregnancy | Breast Feeding | Fertility Barrier Contraception

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0015895
UMLS CUI [3,2]
C0004764
other protocol-defined inclusion/exclusion criteria may apply.
Beskrivning

Clinical Trial Eligibility Criteria Study Protocol

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
Tillbaka till toppen

Similar models

Eligibility Solid Tumors NCT00600275

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Patients All
Item
all patients
boolean
C0030705 (UMLS CUI [1,1])
C0444868 (UMLS CUI [1,2])
Solid tumour Advanced
Item
histologically-confirmed, advanced solid tumors
boolean
C0280100 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
Progressive Disease | Recurrent disease unresectable
Item
progressive, recurrent unresectable disease
boolean
C1335499 (UMLS CUI [1])
C0277556 (UMLS CUI [2,1])
C1519810 (UMLS CUI [2,2])
Phase 2 Clinical Trial | Advanced breast cancer
Item
phase ii expansion part (advanced breast cancer)
boolean
C0282460 (UMLS CUI [1])
C3495917 (UMLS CUI [2])
Hormone Receptor/HER2 Positive | Estrogen receptor positive | Progesterone receptor positive | HER2/Neu Positive
Item
confirmed positive hormone receptor (estrogen receptor and/or progesterone receptor) or positive her-2 expression status
boolean
C3898879 (UMLS CUI [1])
C0279754 (UMLS CUI [2])
C0279759 (UMLS CUI [3])
C2348909 (UMLS CUI [4])
Disease Progression | Recurrent disease | Hormone Therapy Advanced disease | Anti HER2 Advanced disease
Item
disease progression/recurrence following hormonal or anti-her-2 treatment for advanced disease
boolean
C0242656 (UMLS CUI [1])
C0277556 (UMLS CUI [2])
C0279025 (UMLS CUI [3,1])
C0679246 (UMLS CUI [3,2])
C0728747 (UMLS CUI [4,1])
C0679246 (UMLS CUI [4,2])
Chemotherapy Regimen Quantity Unresectable Malignant Neoplasm
Item
at least one but not more than two prior chemotherapy regimens for the unresectable tumor
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1336869 (UMLS CUI [1,3])
Measurable Disease MRI | Measurable Disease CT scan
Item
measurable disease by mri or ct scan
boolean
C1513041 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C1513041 (UMLS CUI [2,1])
C0040405 (UMLS CUI [2,2])
Cowden Syndrome Advanced
Item
cowden syndrome patients with an advanced malignancy genetic confirmation of cowden syndrome
boolean
C0018553 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
Age
Item
age ≥ 18
boolean
C0001779 (UMLS CUI [1])
WHO performance status scale
Item
world health organization (who) performance status of ≤ 2
boolean
C1298650 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hematopoietic
Item
hematopoietic:
boolean
C0229601 (UMLS CUI [1])
Diabetes Mellitus | History of gestational diabetes mellitus
Item
no diabetes mellitus or history of gestational diabetes mellitus
boolean
C0011849 (UMLS CUI [1])
C2183115 (UMLS CUI [2])
Kidney Diseases | Chronic Kidney Diseases
Item
no acute or chronic renal disease
boolean
C0022658 (UMLS CUI [1])
C1561643 (UMLS CUI [2])
Liver disease | Chronic liver disease
Item
no acute or chronic liver disease
boolean
C0023895 (UMLS CUI [1])
C0341439 (UMLS CUI [2])
Pancreatitis | Pancreatitis, Chronic
Item
no acute or chronic pancreatitis
boolean
C0030305 (UMLS CUI [1])
C0149521 (UMLS CUI [2])
Decreased cardiac function | Heart Diseases | Ventricular arrhythmia | Congestive heart failure | Uncontrolled hypertension
Item
no impaired cardiac function or clinically significant cardiac diseases such as ventricular arrhythmia, congestive heart failure, uncontrolled hypertension
boolean
C0232166 (UMLS CUI [1])
C0018799 (UMLS CUI [2])
C0085612 (UMLS CUI [3])
C0018802 (UMLS CUI [4])
C1868885 (UMLS CUI [5])
Myocardial Infarction | Angina, Unstable
Item
no acute myocardial infarction or unstable angina pectoris within the past 3 months
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
Pregnancy | Breast Feeding | Fertility Barrier Contraception
Item
not pregnant or nursing and fertile patients must use barrier contraceptives
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0015895 (UMLS CUI [3,1])
C0004764 (UMLS CUI [3,2])
Clinical Trial Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply.
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial