ID

34985

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT02202746

Nyckelord

Versioner (1)
  1. 2019-02-06 2019-02-06 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

6 februari 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02202746

Engelsk

Eligibility Breast Cancer NCT02202746

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

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

Datatyp

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
Beskrivning

First line treatment Standard Neoplasm Metastasis

Datatyp

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
Beskrivning

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

Datatyp

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)
Beskrivning

Disease Progression | Measurable Disease

Datatyp

boolean

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

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Beskrivning

Exclusion Criteria

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

Cancer treatment biological

Datatyp

boolean

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

Adverse events Due to Cancer treatment

Datatyp

boolean

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

CNS metastases

Datatyp

boolean

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

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

Datatyp

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
Beskrivning

Pregnancy | Breast Feeding

Datatyp

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
Beskrivning

Chemotherapy Quantity Neoplasm Metastasis

Datatyp

boolean

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

Eligibility Breast Cancer NCT02202746

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
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