ID

36847

Beskrivning

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.

Länk

https://clinicaltrials.gov/show/NCT01677455

Nyckelord

Versioner (1)
  1. 2019-06-15 2019-06-15 -
Rättsinnehavare

Synta Pharmaceuticals Corp.

Uppladdad den

15 juni 2019

DOI

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Licens

Creative Commons BY-NC 3.0
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Ganetespib in Breast Cancer NCT01677455

Engelsk

Eligibility Criteria

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Confirmed invasive breast cancer

Datatyp

boolean

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

Stage IV disease

Datatyp

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.
Beskrivning

HER2 and hormone receptor status

Datatyp

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?
Beskrivning

ECOG performance status

Datatyp

boolean

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

Recist measurable disease

Datatyp

boolean

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

Adequate hematological function

Datatyp

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?
Beskrivning

Adequate hepatic function

Datatyp

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.
Beskrivning

Adequate renal function

Datatyp

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?
Beskrivning

Negative serum pregnancy test

Datatyp

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?
Beskrivning

Informed Consent

Datatyp

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
Beskrivning

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?
Beskrivning

CNS metastases

Datatyp

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?
Beskrivning

Other active malignancies

Datatyp

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?
Beskrivning

Only bone metastases

Datatyp

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?
Beskrivning

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

Datatyp

boolean

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

Pregnancy or lactation

Datatyp

boolean

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

Serious cardiac illness

Datatyp

boolean

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

Uncontrolled intercurrent illness

Datatyp

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?
Beskrivning

Medical condition interfering with study aspects

Datatyp

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 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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