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ID

36847

Beschrijving

An Open-Label Multicenter Phase 2 Window of Opportunity Study Evaluating Ganetespib in Women With Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01677455 The purpose of this study is to determine if ganetespib (STA-9090) is effective in the treatment of patients with HER2+ or triple negative breast cancer who have not received prior systemic treatment in the metastatic setting.

Link

https://clinicaltrials.gov/show/NCT01677455

Trefwoorden

Versies (1)
  1. 15-06-19 15-06-19 -
Houder van rechten

Synta Pharmaceuticals Corp.

Geüploaded op

15 juni 2019

DOI

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Licentie

Creative Commons BY-NC 3.0
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    Ganetespib in Breast Cancer NCT01677455

    Engels

    Eligibility Criteria

    1 Formulieren  
    1. StudyEvent: Eligibility
      1. Eligibility Criteria
    Inclusion Criteria
    Beschrijving

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    Does the participant have a pathologically confirmed diagnosis of invasive breast cancer?
    Beschrijving

    Confirmed invasive breast cancer

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0030664
    UMLS CUI [1,2]
    C0521091
    UMLS CUI [1,3]
    C0853879
    Does the participant have stage IV disease?
    Beschrijving

    Stage IV disease

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0278488
    Does the participant have documented her2 and hormonal receptor status per protocol, er/pr+ patients must be refractory to at least one prior hormonal treatment.
    Beschrijving

    HER2 and hormone receptor status

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0175636
    UMLS CUI [1,2]
    C0449438
    UMLS CUI [1,3]
    C3824899
    UMLS CUI [1,4]
    C0019929
    UMLS CUI [2,1]
    C4745239
    UMLS CUI [2,2]
    C0205269
    UMLS CUI [2,3]
    C0279025
    Does the participant have a ecog performance status 0-1?
    Beschrijving

    ECOG performance status

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    Does the participant have measurable disease per recist (1.1)?
    Beschrijving

    Recist measurable disease

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C1513041
    UMLS CUI [1,2]
    C1709926
    Does the participant have a adequate hematological function per protocol?
    Beschrijving

    Adequate hematological function

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0205411
    UMLS CUI [1,2]
    C0542341
    UMLS CUI [1,3]
    C0018941
    UMLS CUI [1,4]
    C0442711
    Does the participant have an adequate hepatic function per protocol?
    Beschrijving

    Adequate hepatic function

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0205411
    UMLS CUI [1,2]
    C0542341
    UMLS CUI [1,3]
    C0023884
    UMLS CUI [1,4]
    C0442711
    Does the participant have an adequate renal function per protocol.
    Beschrijving

    Adequate renal function

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0205411
    UMLS CUI [1,2]
    C0542341
    UMLS CUI [1,3]
    C0022646
    UMLS CUI [1,4]
    C0442711
    Does the participant have a negative serum pregnancy test at study entry for patients of childbearing potential?
    Beschrijving

    Negative serum pregnancy test

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0430061
    UMLS CUI [1,2]
    C3831118
    Does the participant have the ability to understand and sign written consent and to comply with the study protocol?
    Beschrijving

    Informed Consent

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C1273101
    UMLS CUI [1,2]
    C0009797
    UMLS CUI [2,1]
    C0085732
    UMLS CUI [2,2]
    C1519316
    UMLS CUI [2,3]
    C0009797
    UMLS CUI [3,1]
    C0582783
    UMLS CUI [3,2]
    C2348563
    Exclusion Criteria
    Beschrijving

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    Does the participant have presence of active or untreated cns metastases as determined by mri/ct scan performed during screening?
    Beschrijving

    CNS metastases

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0205177
    UMLS CUI [1,2]
    C0686377
    UMLS CUI [1,3]
    C0024485
    UMLS CUI [1,4]
    C0220908
    UMLS CUI [2,1]
    C0332155
    UMLS CUI [2,2]
    C0686377
    UMLS CUI [2,3]
    C0024485
    UMLS CUI [2,4]
    C0220908
    Does the participant have active malignancies other than mbc within the last 5 years except adequately treated in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin?
    Beschrijving

    Other active malignancies

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0205177
    UMLS CUI [1,2]
    C0006826
    UMLS CUI [1,3]
    C0205394
    UMLS CUI [2,1]
    C0332300
    UMLS CUI [2,2]
    C0007099
    UMLS CUI [2,3]
    C0007874
    UMLS CUI [3,1]
    C0332300
    UMLS CUI [3,2]
    C0007117
    UMLS CUI [4,1]
    C0332300
    UMLS CUI [4,2]
    C0553723
    Does the participant have bone as the only site of metastatic disease from breast cancer?
    Beschrijving

    Only bone metastases

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0027627
    UMLS CUI [1,2]
    C4698125
    UMLS CUI [1,3]
    C0332300
    UMLS CUI [1,4]
    C0153690
    Does the participant have prior radiotherapy to the only area of measurable disease?
    Beschrijving

    Note: radiotherapy to a limited area other than the sole site of measurable disease is allowed, if received prior to initiation of ganetespib treatment. patients must have completed treatment and recovered from all acute treatment-related toxicities prior to administration of first dose of ganetespib

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0279134
    UMLS CUI [1,2]
    C0205146
    UMLS CUI [1,3]
    C1513041
    Does the participant have pregnancy or lactation?
    Beschrijving

    Pregnancy or lactation

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0022925
    Does the participant have a known serious cardiac illness?
    Beschrijving

    Serious cardiac illness

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0205404
    UMLS CUI [1,2]
    C0018799
    Does the participant have uncontrolled intercurrent illness per protocol?
    Beschrijving

    Uncontrolled intercurrent illness

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0205318
    UMLS CUI [1,2]
    C3640977
    Does the participant have other severe acute or chronic medical condition or abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, or that in the judgment of the investigator would make the patient inappropriate for entry into the study?
    Beschrijving

    Medical condition interfering with study aspects

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0205082
    UMLS CUI [1,2]
    C4745084
    UMLS CUI [1,3]
    C4699158
    UMLS CUI [1,4]
    C2348568
    UMLS CUI [2,1]
    C0205191
    UMLS CUI [2,2]
    C4745084
    UMLS CUI [2,3]
    C4699158
    UMLS CUI [2,4]
    C2348568
    UMLS CUI [3,1]
    C0205082
    UMLS CUI [3,2]
    C4745084
    UMLS CUI [3,3]
    C0521102
    UMLS CUI [3,4]
    C0459471
    UMLS CUI [3,5]
    C0683954
    UMLS CUI [4,1]
    C0205191
    UMLS CUI [4,2]
    C4745084
    UMLS CUI [4,3]
    C0521102
    UMLS CUI [4,4]
    C0459471
    UMLS CUI [4,5]
    C0683954
    UMLS CUI [5,1]
    C0205082
    UMLS CUI [5,2]
    C4745084
    UMLS CUI [5,3]
    C2348568
    UMLS CUI [5,4]
    C1548788
    UMLS CUI [6,1]
    C0205191
    UMLS CUI [6,2]
    C4745084
    UMLS CUI [6,3]
    C2348568
    UMLS CUI [6,4]
    C1548788
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    Similar models

    Eligibility Criteria

    1 Formulieren
    1. StudyEvent: Eligibility
      1. Eligibility Criteria
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Confirmed invasive breast cancer
    Item
    Does the participant have a pathologically confirmed diagnosis of invasive breast cancer?
    boolean
    C0030664 (UMLS CUI [1,1])
    C0521091 (UMLS CUI [1,2])
    C0853879 (UMLS CUI [1,3])
    Stage IV disease
    Item
    Does the participant have stage IV disease?
    boolean
    C0278488 (UMLS CUI [1])
    HER2 and hormone receptor status
    Item
    Does the participant have documented her2 and hormonal receptor status per protocol, er/pr+ patients must be refractory to at least one prior hormonal treatment.
    boolean
    C0175636 (UMLS CUI [1,1])
    C0449438 (UMLS CUI [1,2])
    C3824899 (UMLS CUI [1,3])
    C0019929 (UMLS CUI [1,4])
    C4745239 (UMLS CUI [2,1])
    C0205269 (UMLS CUI [2,2])
    C0279025 (UMLS CUI [2,3])
    ECOG performance status
    Item
    Does the participant have a ecog performance status 0-1?
    boolean
    C1520224 (UMLS CUI [1])
    Recist measurable disease
    Item
    Does the participant have measurable disease per recist (1.1)?
    boolean
    C1513041 (UMLS CUI [1,1])
    C1709926 (UMLS CUI [1,2])
    Adequate hematological function
    Item
    Does the participant have a adequate hematological function per protocol?
    boolean
    C0205411 (UMLS CUI [1,1])
    C0542341 (UMLS CUI [1,2])
    C0018941 (UMLS CUI [1,3])
    C0442711 (UMLS CUI [1,4])
    Adequate hepatic function
    Item
    Does the participant have an adequate hepatic function per protocol?
    boolean
    C0205411 (UMLS CUI [1,1])
    C0542341 (UMLS CUI [1,2])
    C0023884 (UMLS CUI [1,3])
    C0442711 (UMLS CUI [1,4])
    Adequate renal function
    Item
    Does the participant have an adequate renal function per protocol.
    boolean
    C0205411 (UMLS CUI [1,1])
    C0542341 (UMLS CUI [1,2])
    C0022646 (UMLS CUI [1,3])
    C0442711 (UMLS CUI [1,4])
    Negative serum pregnancy test
    Item
    Does the participant have a negative serum pregnancy test at study entry for patients of childbearing potential?
    boolean
    C0430061 (UMLS CUI [1,1])
    C3831118 (UMLS CUI [1,2])
    Informed Consent
    Item
    Does the participant have the ability to understand and sign written consent and to comply with the study protocol?
    boolean
    C1273101 (UMLS CUI [1,1])
    C0009797 (UMLS CUI [1,2])
    C0085732 (UMLS CUI [2,1])
    C1519316 (UMLS CUI [2,2])
    C0009797 (UMLS CUI [2,3])
    C0582783 (UMLS CUI [3,1])
    C2348563 (UMLS CUI [3,2])
    Item Group
    C0680251 (UMLS CUI)
    CNS metastases
    Item
    Does the participant have presence of active or untreated cns metastases as determined by mri/ct scan performed during screening?
    boolean
    C0205177 (UMLS CUI [1,1])
    C0686377 (UMLS CUI [1,2])
    C0024485 (UMLS CUI [1,3])
    C0220908 (UMLS CUI [1,4])
    C0332155 (UMLS CUI [2,1])
    C0686377 (UMLS CUI [2,2])
    C0024485 (UMLS CUI [2,3])
    C0220908 (UMLS CUI [2,4])
    Other active malignancies
    Item
    Does the participant have active malignancies other than mbc within the last 5 years except adequately treated in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin?
    boolean
    C0205177 (UMLS CUI [1,1])
    C0006826 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    C0332300 (UMLS CUI [2,1])
    C0007099 (UMLS CUI [2,2])
    C0007874 (UMLS CUI [2,3])
    C0332300 (UMLS CUI [3,1])
    C0007117 (UMLS CUI [3,2])
    C0332300 (UMLS CUI [4,1])
    C0553723 (UMLS CUI [4,2])
    Only bone metastases
    Item
    Does the participant have bone as the only site of metastatic disease from breast cancer?
    boolean
    C0027627 (UMLS CUI [1,1])
    C4698125 (UMLS CUI [1,2])
    C0332300 (UMLS CUI [1,3])
    C0153690 (UMLS CUI [1,4])
    Prior Radiotherapy
    Item
    Does the participant have prior radiotherapy to the only area of measurable disease?
    boolean
    C0279134 (UMLS CUI [1,1])
    C0205146 (UMLS CUI [1,2])
    C1513041 (UMLS CUI [1,3])
    Pregnancy or lactation
    Item
    Does the participant have pregnancy or lactation?
    boolean
    C0032961 (UMLS CUI [1])
    C0022925 (UMLS CUI [2])
    Serious cardiac illness
    Item
    Does the participant have a known serious cardiac illness?
    boolean
    C0205404 (UMLS CUI [1,1])
    C0018799 (UMLS CUI [1,2])
    Uncontrolled intercurrent illness
    Item
    Does the participant have uncontrolled intercurrent illness per protocol?
    boolean
    C0205318 (UMLS CUI [1,1])
    C3640977 (UMLS CUI [1,2])
    Medical condition interfering with study aspects
    Item
    Does the participant have other severe acute or chronic medical condition or abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, or that in the judgment of the investigator would make the patient inappropriate for entry into the study?
    boolean
    C0205082 (UMLS CUI [1,1])
    C4745084 (UMLS CUI [1,2])
    C4699158 (UMLS CUI [1,3])
    C2348568 (UMLS CUI [1,4])
    C0205191 (UMLS CUI [2,1])
    C4745084 (UMLS CUI [2,2])
    C4699158 (UMLS CUI [2,3])
    C2348568 (UMLS CUI [2,4])
    C0205082 (UMLS CUI [3,1])
    C4745084 (UMLS CUI [3,2])
    C0521102 (UMLS CUI [3,3])
    C0459471 (UMLS CUI [3,4])
    C0683954 (UMLS CUI [3,5])
    C0205191 (UMLS CUI [4,1])
    C4745084 (UMLS CUI [4,2])
    C0521102 (UMLS CUI [4,3])
    C0459471 (UMLS CUI [4,4])
    C0683954 (UMLS CUI [4,5])
    C0205082 (UMLS CUI [5,1])
    C4745084 (UMLS CUI [5,2])
    C2348568 (UMLS CUI [5,3])
    C1548788 (UMLS CUI [5,4])
    C0205191 (UMLS CUI [6,1])
    C4745084 (UMLS CUI [6,2])
    C2348568 (UMLS CUI [6,3])
    C1548788 (UMLS CUI [6,4])
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