ID

38222

Descrição

A Phase II Trial Testing Oral Administration of Lucitanib in Patients With Fibroblast Growth Factor Receptor (FGFR)1-amplified or Non-amplified Estrogen Receptor Positive Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02053636

Link

https://clinicaltrials.gov/show/NCT02053636

Palavras-chave

Versões (1)
  1. 29/09/2019 29/09/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

29 de setembro de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02053636

Inglês

Eligibility Breast Cancer NCT02053636

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed breast adenocarcinoma.
Descrição

Breast adenocarcinoma

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0858252
presence of an accessible metastatic lesion for biopsy or at least one archived metastatic tumour sample.
Descrição

Metastatic Lesion Amenable Biopsy | Tumor tissue sample metastatic Quantity

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1513183
UMLS CUI [1,2]
C3900053
UMLS CUI [1,3]
C0005558
UMLS CUI [2,1]
C0475358
UMLS CUI [2,2]
C1522484
UMLS CUI [2,3]
C1265611
prior first-line hormonal therapy in the metastatic setting.
Descrição

First line Hormone Therapy Neoplasm Metastasis

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1708063
UMLS CUI [1,2]
C0279025
UMLS CUI [1,3]
C0027627
demonstrated progression of disease by radiological or clinical assessment.
Descrição

Disease Progression

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0242656
female patient, aged ≥18 years old.
Descrição

Gender | Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
estimated life expectancy >3 months.
Descrição

Life Expectancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023671
normal left ventricular function
Descrição

Left Ventricular Function

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0080310
adequate haematological, hepatic and renal functions.
Descrição

Hematologic function | Liver function | Renal function

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
for women with childbearing potential, a negative pregnancy test prior to initiation of the study drug and willingness to use an effective contraception.
Descrição

Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
ability to swallow oral capsules.
Descrição

Able to swallow Capsules

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0006935
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
more than two lines of chemotherapy and two lines of hormonal therapy with or without targeted therapy in the metastatic setting.
Descrição

Chemotherapy Quantity Neoplasm Metastasis | Hormone Therapy Quantity Neoplasm Metastasis | Targeted Therapy Neoplasm Metastasis | Targeted Therapy Absent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0027627
UMLS CUI [2,1]
C0279025
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0027627
UMLS CUI [3,1]
C2985566
UMLS CUI [3,2]
C0027627
UMLS CUI [4,1]
C2985566
UMLS CUI [4,2]
C0332197
previous treatment with bevacizumab within 3 months of first dose of investigational medicinal product.
Descrição

bevacizumab

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0796392
active central nervous system metastases, cerebral oedema, and/or progressive growth.
Descrição

CNS metastases | Cerebral Edema | Growth Progressive

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0686377
UMLS CUI [2]
C0006114
UMLS CUI [3,1]
C0018270
UMLS CUI [3,2]
C0205329
patients with impaired cardiac function.
Descrição

Decreased cardiac function

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0232166
uncontrolled arterial hypertension
Descrição

Uncontrolled hypertension

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1868885
patients with history of thrombotic disorders or hereditary risk factors of thromboembolic events
Descrição

Thrombosis | Risk factors Hereditary Thromboembolic event

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0040053
UMLS CUI [2,1]
C0035648
UMLS CUI [2,2]
C0439660
UMLS CUI [2,3]
C0040038
serum potassium level below lower limit of normal
Descrição

Serum potassium decreased

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0595885
uncontrolled hypothyroidism.
Descrição

Hypothyroidism Uncontrolled

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020676
UMLS CUI [1,2]
C0205318
pregnant or breastfeeding women.
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Breast Cancer NCT02053636

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Breast adenocarcinoma
Item
histologically confirmed breast adenocarcinoma.
boolean
C0858252 (UMLS CUI [1])
Metastatic Lesion Amenable Biopsy | Tumor tissue sample metastatic Quantity
Item
presence of an accessible metastatic lesion for biopsy or at least one archived metastatic tumour sample.
boolean
C1513183 (UMLS CUI [1,1])
C3900053 (UMLS CUI [1,2])
C0005558 (UMLS CUI [1,3])
C0475358 (UMLS CUI [2,1])
C1522484 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
First line Hormone Therapy Neoplasm Metastasis
Item
prior first-line hormonal therapy in the metastatic setting.
boolean
C1708063 (UMLS CUI [1,1])
C0279025 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
Disease Progression
Item
demonstrated progression of disease by radiological or clinical assessment.
boolean
C0242656 (UMLS CUI [1])
Gender | Age
Item
female patient, aged ≥18 years old.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Life Expectancy
Item
estimated life expectancy >3 months.
boolean
C0023671 (UMLS CUI [1])
Left Ventricular Function
Item
normal left ventricular function
boolean
C0080310 (UMLS CUI [1])
Hematologic function | Liver function | Renal function
Item
adequate haematological, hepatic and renal functions.
boolean
C0221130 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods
Item
for women with childbearing potential, a negative pregnancy test prior to initiation of the study drug and willingness to use an effective contraception.
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Able to swallow Capsules
Item
ability to swallow oral capsules.
boolean
C2712086 (UMLS CUI [1,1])
C0006935 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Chemotherapy Quantity Neoplasm Metastasis | Hormone Therapy Quantity Neoplasm Metastasis | Targeted Therapy Neoplasm Metastasis | Targeted Therapy Absent
Item
more than two lines of chemotherapy and two lines of hormonal therapy with or without targeted therapy in the metastatic setting.
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
C0279025 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0027627 (UMLS CUI [2,3])
C2985566 (UMLS CUI [3,1])
C0027627 (UMLS CUI [3,2])
C2985566 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
bevacizumab
Item
previous treatment with bevacizumab within 3 months of first dose of investigational medicinal product.
boolean
C0796392 (UMLS CUI [1])
CNS metastases | Cerebral Edema | Growth Progressive
Item
active central nervous system metastases, cerebral oedema, and/or progressive growth.
boolean
C0686377 (UMLS CUI [1])
C0006114 (UMLS CUI [2])
C0018270 (UMLS CUI [3,1])
C0205329 (UMLS CUI [3,2])
Decreased cardiac function
Item
patients with impaired cardiac function.
boolean
C0232166 (UMLS CUI [1])
Uncontrolled hypertension
Item
uncontrolled arterial hypertension
boolean
C1868885 (UMLS CUI [1])
Thrombosis | Risk factors Hereditary Thromboembolic event
Item
patients with history of thrombotic disorders or hereditary risk factors of thromboembolic events
boolean
C0040053 (UMLS CUI [1])
C0035648 (UMLS CUI [2,1])
C0439660 (UMLS CUI [2,2])
C0040038 (UMLS CUI [2,3])
Serum potassium decreased
Item
serum potassium level below lower limit of normal
boolean
C0595885 (UMLS CUI [1])
Hypothyroidism Uncontrolled
Item
uncontrolled hypothyroidism.
boolean
C0020676 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnant or breastfeeding women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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