ID

34985

Beschreibung

A Study to Assess the Safety and Efficacy of the VEGFR-FGFR Inhibitor, Lucitanib, Given to Patients With FGF Aberrant Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02202746

Link

https://clinicaltrials.gov/show/NCT02202746

Stichworte

  1. 06.02.19 06.02.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

6. Februar 2019

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0

Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Breast Cancer NCT02202746

Eligibility Breast Cancer NCT02202746

Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed metastatic breast cancer relapsed or refractory to approved standard available treatment
Beschreibung

BREAST CANCER METASTATIC RECURRENT | Secondary malignant neoplasm of female breast Unresponsive to Standard therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0741681
UMLS CUI [2,1]
C0346993
UMLS CUI [2,2]
C0205269
UMLS CUI [2,3]
C2936643
prior treatment with standard first line therapy in the metastatic setting
Beschreibung

First line treatment Standard Neoplasm Metastasis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1708063
UMLS CUI [1,2]
C1442989
UMLS CUI [1,3]
C0027627
availability of tumor tissue sufficient for confirmatory testing of fgfr1 and 11q amplification status
Beschreibung

Availability of Tumor tissue sample | FGFR1 Gene Amplification Testing | 11q Amplification Testing

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C0475358
UMLS CUI [2,1]
C1517090
UMLS CUI [2,2]
C0039593
UMLS CUI [3,1]
C0796366
UMLS CUI [3,2]
C1521871
UMLS CUI [3,3]
C0039593
demonstrated progression of disease by radiological or clinical assessment (measurable disease according to recist version 1.1 is not required for enrollment)
Beschreibung

Disease Progression | Measurable Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2]
C1513041
estimated life expectancy >6 months
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
current or recent treatment with biologic anticancer therapies
Beschreibung

Cancer treatment biological

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205460
ongoing aes from prior anticancer therapies
Beschreibung

Adverse events Due to Cancer treatment

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0920425
active central nervous system (cns) metastases
Beschreibung

CNS metastases

Datentyp

boolean

Alias
UMLS CUI [1]
C0686377
clinically significant or uncontrolled hypertension or cardiac disease
Beschreibung

Hypertensive disease Clinical Significance | Uncontrolled hypertension | Heart Disease Clinical Significance | Heart Disease Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020538
UMLS CUI [1,2]
C2826293
UMLS CUI [2]
C1868885
UMLS CUI [3,1]
C0018799
UMLS CUI [3,2]
C2826293
UMLS CUI [4,1]
C0018799
UMLS CUI [4,2]
C0205318
females who are pregnant or breastfeeding
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
for cohort c (biomarker-negative) patients: greater than 3 lines of previous chemotherapy in the metastatic setting
Beschreibung

Chemotherapy Quantity Neoplasm Metastasis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0027627

Ähnliche Modelle

Eligibility Breast Cancer NCT02202746

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
BREAST CANCER METASTATIC RECURRENT | Secondary malignant neoplasm of female breast Unresponsive to Standard therapy
Item
histologically or cytologically confirmed metastatic breast cancer relapsed or refractory to approved standard available treatment
boolean
C0741681 (UMLS CUI [1])
C0346993 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
C2936643 (UMLS CUI [2,3])
First line treatment Standard Neoplasm Metastasis
Item
prior treatment with standard first line therapy in the metastatic setting
boolean
C1708063 (UMLS CUI [1,1])
C1442989 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
Availability of Tumor tissue sample | FGFR1 Gene Amplification Testing | 11q Amplification Testing
Item
availability of tumor tissue sufficient for confirmatory testing of fgfr1 and 11q amplification status
boolean
C0470187 (UMLS CUI [1,1])
C0475358 (UMLS CUI [1,2])
C1517090 (UMLS CUI [2,1])
C0039593 (UMLS CUI [2,2])
C0796366 (UMLS CUI [3,1])
C1521871 (UMLS CUI [3,2])
C0039593 (UMLS CUI [3,3])
Disease Progression | Measurable Disease
Item
demonstrated progression of disease by radiological or clinical assessment (measurable disease according to recist version 1.1 is not required for enrollment)
boolean
C0242656 (UMLS CUI [1])
C1513041 (UMLS CUI [2])
Life Expectancy
Item
estimated life expectancy >6 months
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cancer treatment biological
Item
current or recent treatment with biologic anticancer therapies
boolean
C0920425 (UMLS CUI [1,1])
C0205460 (UMLS CUI [1,2])
Adverse events Due to Cancer treatment
Item
ongoing aes from prior anticancer therapies
boolean
C0877248 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0920425 (UMLS CUI [1,3])
CNS metastases
Item
active central nervous system (cns) metastases
boolean
C0686377 (UMLS CUI [1])
Hypertensive disease Clinical Significance | Uncontrolled hypertension | Heart Disease Clinical Significance | Heart Disease Uncontrolled
Item
clinically significant or uncontrolled hypertension or cardiac disease
boolean
C0020538 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C1868885 (UMLS CUI [2])
C0018799 (UMLS CUI [3,1])
C2826293 (UMLS CUI [3,2])
C0018799 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
Pregnancy | Breast Feeding
Item
females who are pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Chemotherapy Quantity Neoplasm Metastasis
Item
for cohort c (biomarker-negative) patients: greater than 3 lines of previous chemotherapy in the metastatic setting
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video