ID

25354

Description

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

Link

https://clinicaltrials.gov/show/NCT00600275

Keywords

Versions (1)
  1. 9/2/17 9/2/17 -
Uploaded on

September 2, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Solid Tumors NCT00600275

English

Eligibility Solid Tumors NCT00600275

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
all patients
Description

Patients All

Data type

boolean

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

Solid tumour Advanced

Data type

boolean

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

Progressive Disease | Recurrent disease unresectable

Data type

boolean

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

Phase 2 Clinical Trial | Advanced breast cancer

Data type

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
Description

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

Data type

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
Description

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

Data type

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
Description

Chemotherapy Regimen Quantity Unresectable Malignant Neoplasm

Data type

boolean

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

Measurable Disease MRI | Measurable Disease CT scan

Data type

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
Description

Cowden Syndrome Advanced

Data type

boolean

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

Age

Data type

boolean

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

WHO performance status scale

Data type

boolean

Alias
UMLS CUI [1]
C1298650
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
hematopoietic:
Description

Hematopoietic

Data type

boolean

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

Diabetes Mellitus | History of gestational diabetes mellitus

Data type

boolean

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

Kidney Diseases | Chronic Kidney Diseases

Data type

boolean

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

Liver disease | Chronic liver disease

Data type

boolean

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

Pancreatitis | Pancreatitis, Chronic

Data type

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
Description

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

Data type

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
Description

Myocardial Infarction | Angina, Unstable

Data type

boolean

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

Pregnancy | Breast Feeding | Fertility Barrier Contraception

Data type

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.
Description

Clinical Trial Eligibility Criteria Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Solid Tumors NCT00600275

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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