ID

29845

Beskrivning

Phase II Study Evaluating Exemestane Alone Or In Combination With Pazopanib In Postmenopausal Women With Hormone Receptor Positive Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00615524

Länk

https://clinicaltrials.gov/show/NCT00615524

Nyckelord

Versioner (1)
  1. 2018-04-24 2018-04-24 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

24 april 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Hormone-receptor Positive Breast Cancer NCT00615524

Engelsk

Eligibility Hormone-receptor Positive Breast Cancer NCT00615524

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects must have measurable disease or must be evaluable for disease progression
Beskrivning

Measurable Disease | Evaluable Patient Disease Progression

Datatyp

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2,1]
C2986511
UMLS CUI [2,2]
C0242656
age >/= 18 years.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
postmenopausal women
Beskrivning

Postmenopausal state

Datatyp

boolean

Alias
UMLS CUI [1]
C0232970
eastern cooperative oncology group (ecog) performance status (ps) 0 or 1.
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
histologically or cytologically confirmed er and/or pgr positive carcinoma of the breast with unresectable, locally advanced and/or metastatic disease
Beskrivning

Oestrogen receptor positive breast cancer | Breast Carcinoma Progesterone receptor positive | Disease unresectable | Disease Advanced Locally | Neoplasm Metastasis

Datatyp

boolean

Alias
UMLS CUI [1]
C2938924
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C0279759
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C1519810
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C0205179
UMLS CUI [4,3]
C1517927
UMLS CUI [5]
C0027627
subjects must have received prior hormonal therapy for the treatment of breast cancer (anastrozole, letrozole, or tamoxifen)
Beskrivning

Prior Hormone Therapy Breast Carcinoma | anastrozole | letrozole | Tamoxifen

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514460
UMLS CUI [1,2]
C0678222
UMLS CUI [2]
C0290883
UMLS CUI [3]
C0246421
UMLS CUI [4]
C0039286
adequate hematologic, hepatic, and renal function
Beskrivning

Hematologic function | Liver function | Renal function

Datatyp

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior use of exemestane or pazopanib
Beskrivning

exemestane | pazopanib

Datatyp

boolean

Alias
UMLS CUI [1]
C0851344
UMLS CUI [2]
C1831796
premenopausal women
Beskrivning

Premenopausal state

Datatyp

boolean

Alias
UMLS CUI [1]
C0232969
any ongoing toxicity from prior anti-cancer therapy that is >grade 1 and/or that is progressing in severity.
Beskrivning

Cancer treatment | Toxicity CTCAE Grades | Toxicity Severitiy Progressing

Datatyp

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2,1]
C0600688
UMLS CUI [2,2]
C1516728
UMLS CUI [3,1]
C0600688
UMLS CUI [3,2]
C0439793
UMLS CUI [3,3]
C0205329
prior therapy with a vegf inhibitor.
Beskrivning

Vascular Endothelial Growth Factor Inhibitors

Datatyp

boolean

Alias
UMLS CUI [1]
C2267120
use of an investigational agent, including an investigational anti-cancer agent, within 28 days or 5 half-lives, whichever is longer, prior to the first dose of investigational product.
Beskrivning

Investigational New Drugs | Antineoplastic Agents Investigational

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2,1]
C0003392
UMLS CUI [2,2]
C1517586
evidence of recurrence or active disease from prior malignancy.
Beskrivning

Recurrent disease | Disease Due to Malignant Neoplasms

Datatyp

boolean

Alias
UMLS CUI [1]
C0277556
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0006826
clinically significant gastrointestinal abnormalities that may increase the risk for gi bleeding or affect the absorption of the investigational product(s).
Beskrivning

Abnormality of the gastrointestinal tract At risk Gastrointestinal Hemorrhage | Abnormality of the gastrointestinal tract Affecting Absorption Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4023588
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C0017181
UMLS CUI [2,1]
C4023588
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0237442
UMLS CUI [2,4]
C0013230
presence of uncontrolled infection.
Beskrivning

Communicable Disease Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
history of any major cardiovascular conditions within the past 6 months:
Beskrivning

Cardiovascular Disease Major

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0205164
poorly controlled hypertension
Beskrivning

Hypertensive disease Poorly controlled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020538
UMLS CUI [1,2]
C3853134
history of cerebrovascular accident, pulmonary embolism or untreated deep venous thrombosis (dvt) within the past 6 months.
Beskrivning

Cerebrovascular accident | Pulmonary Embolism | Deep Vein Thrombosis untreated

Datatyp

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0034065
UMLS CUI [3,1]
C0149871
UMLS CUI [3,2]
C0332155
prior major surgery or trauma within 28 days prior to first dose of investigational product and/or presence of any non-healing wound, fracture, or ulcer
Beskrivning

Major surgery | Trauma | Wound, non-healed | Fracture | Ulcer

Datatyp

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2]
C3714660
UMLS CUI [3]
C0750433
UMLS CUI [4]
C0016658
UMLS CUI [5]
C0041582
evidence of active bleeding or bleeding tendency.
Beskrivning

Hemorrhage | Bleeding tendency

Datatyp

boolean

Alias
UMLS CUI [1]
C0019080
UMLS CUI [2]
C1458140
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Similar models

Eligibility Hormone-receptor Positive Breast Cancer NCT00615524

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Measurable Disease | Evaluable Patient Disease Progression
Item
subjects must have measurable disease or must be evaluable for disease progression
boolean
C1513041 (UMLS CUI [1])
C2986511 (UMLS CUI [2,1])
C0242656 (UMLS CUI [2,2])
Age
Item
age >/= 18 years.
boolean
C0001779 (UMLS CUI [1])
Postmenopausal state
Item
postmenopausal women
boolean
C0232970 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status (ps) 0 or 1.
boolean
C1520224 (UMLS CUI [1])
Oestrogen receptor positive breast cancer | Breast Carcinoma Progesterone receptor positive | Disease unresectable | Disease Advanced Locally | Neoplasm Metastasis
Item
histologically or cytologically confirmed er and/or pgr positive carcinoma of the breast with unresectable, locally advanced and/or metastatic disease
boolean
C2938924 (UMLS CUI [1])
C0678222 (UMLS CUI [2,1])
C0279759 (UMLS CUI [2,2])
C0012634 (UMLS CUI [3,1])
C1519810 (UMLS CUI [3,2])
C0012634 (UMLS CUI [4,1])
C0205179 (UMLS CUI [4,2])
C1517927 (UMLS CUI [4,3])
C0027627 (UMLS CUI [5])
Prior Hormone Therapy Breast Carcinoma | anastrozole | letrozole | Tamoxifen
Item
subjects must have received prior hormonal therapy for the treatment of breast cancer (anastrozole, letrozole, or tamoxifen)
boolean
C1514460 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0290883 (UMLS CUI [2])
C0246421 (UMLS CUI [3])
C0039286 (UMLS CUI [4])
Hematologic function | Liver function | Renal function
Item
adequate hematologic, hepatic, and renal function
boolean
C0221130 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
exemestane | pazopanib
Item
prior use of exemestane or pazopanib
boolean
C0851344 (UMLS CUI [1])
C1831796 (UMLS CUI [2])
Premenopausal state
Item
premenopausal women
boolean
C0232969 (UMLS CUI [1])
Cancer treatment | Toxicity CTCAE Grades | Toxicity Severitiy Progressing
Item
any ongoing toxicity from prior anti-cancer therapy that is >grade 1 and/or that is progressing in severity.
boolean
C0920425 (UMLS CUI [1])
C0600688 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
C0600688 (UMLS CUI [3,1])
C0439793 (UMLS CUI [3,2])
C0205329 (UMLS CUI [3,3])
Vascular Endothelial Growth Factor Inhibitors
Item
prior therapy with a vegf inhibitor.
boolean
C2267120 (UMLS CUI [1])
Investigational New Drugs | Antineoplastic Agents Investigational
Item
use of an investigational agent, including an investigational anti-cancer agent, within 28 days or 5 half-lives, whichever is longer, prior to the first dose of investigational product.
boolean
C0013230 (UMLS CUI [1])
C0003392 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])
Recurrent disease | Disease Due to Malignant Neoplasms
Item
evidence of recurrence or active disease from prior malignancy.
boolean
C0277556 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0006826 (UMLS CUI [2,3])
Abnormality of the gastrointestinal tract At risk Gastrointestinal Hemorrhage | Abnormality of the gastrointestinal tract Affecting Absorption Investigational New Drugs
Item
clinically significant gastrointestinal abnormalities that may increase the risk for gi bleeding or affect the absorption of the investigational product(s).
boolean
C4023588 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0017181 (UMLS CUI [1,3])
C4023588 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0237442 (UMLS CUI [2,3])
C0013230 (UMLS CUI [2,4])
Communicable Disease Uncontrolled
Item
presence of uncontrolled infection.
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Cardiovascular Disease Major
Item
history of any major cardiovascular conditions within the past 6 months:
boolean
C0007222 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
Hypertensive disease Poorly controlled
Item
poorly controlled hypertension
boolean
C0020538 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
Cerebrovascular accident | Pulmonary Embolism | Deep Vein Thrombosis untreated
Item
history of cerebrovascular accident, pulmonary embolism or untreated deep venous thrombosis (dvt) within the past 6 months.
boolean
C0038454 (UMLS CUI [1])
C0034065 (UMLS CUI [2])
C0149871 (UMLS CUI [3,1])
C0332155 (UMLS CUI [3,2])
Major surgery | Trauma | Wound, non-healed | Fracture | Ulcer
Item
prior major surgery or trauma within 28 days prior to first dose of investigational product and/or presence of any non-healing wound, fracture, or ulcer
boolean
C0679637 (UMLS CUI [1])
C3714660 (UMLS CUI [2])
C0750433 (UMLS CUI [3])
C0016658 (UMLS CUI [4])
C0041582 (UMLS CUI [5])
Hemorrhage | Bleeding tendency
Item
evidence of active bleeding or bleeding tendency.
boolean
C0019080 (UMLS CUI [1])
C1458140 (UMLS CUI [2])
Tillbaka till toppen 

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