ID

26215

Beschrijving

Study to Evaluate Exemestane With and Without SNDX-275 in Treatment of Postmenopausal Women With Advanced Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00676663

Link

https://clinicaltrials.gov/show/NCT00676663

Trefwoorden

Versies (1)
  1. 11-10-17 11-10-17 -
Houder van rechten

See clinicaltrials.gov

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11 oktober 2017

DOI

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Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00676663

Engels

Eligibility Breast Cancer NCT00676663

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
postmenopausal female patients
Beschrijving

Postmenopausal state

Datatype

boolean

Alias
UMLS CUI [1]
C0232970
histologically or cytologically confirmed er+ breast cancer
Beschrijving

Oestrogen receptor positive breast cancer

Datatype

boolean

Alias
UMLS CUI [1]
C2938924
relapsed or progressed on prior treatment with ai
Beschrijving

Aromatase Inhibitors | Recurrent disease | Disease Progression

Datatype

boolean

Alias
UMLS CUI [1]
C0593802
UMLS CUI [2]
C0277556
UMLS CUI [3]
C0242656
metastatic disease must be measurable
Beschrijving

Neoplasm Metastasis Measurable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C1513040
patients receiving palliative radiation at the non-target lesions must have a 2 week wash out period following completion of the treatment prior to enrollment
Beschrijving

Palliative Radiation Therapy Lesion Non-Target | Washout Period Patient need for

Datatype

boolean

Alias
UMLS CUI [1,1]
C3898008
UMLS CUI [1,2]
C0221198
UMLS CUI [1,3]
C1518389
UMLS CUI [2,1]
C1710661
UMLS CUI [2,2]
C0686904
patient may have had one prior chemotherapy as part of first line therapy as long as it was received before initiation of prior ai
Beschrijving

First line treatment Prior Chemotherapy Quantity | Status pre- Aromatase Inhibitors

Datatype

boolean

Alias
UMLS CUI [1,1]
C1708063
UMLS CUI [1,2]
C1514457
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0332152
UMLS CUI [2,2]
C0593802
ecog performance status: 0 to 1
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
laboratory parameters: a)hemoglobin ≥ 9.0 g/dl; platelets ≥ 100.0 x 109/l; anc ≥ 1.5 x 109/l without the use of hematopoietic growth factors b)creatinine less than 2.5 times the upper limit of normal for the institution c)ast and alt less than 2.5 times the upper limit of normal for the institution
Beschrijving

Laboratory Results | Hemoglobin measurement | Platelet Count measurement | Absolute neutrophil count | Hematopoietic Growth Factors Absent | Creatinine measurement, serum | Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datatype

boolean

Alias
UMLS CUI [1]
C1254595
UMLS CUI [2]
C0518015
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0948762
UMLS CUI [5,1]
C0079490
UMLS CUI [5,2]
C0332197
UMLS CUI [6]
C0201976
UMLS CUI [7]
C0201899
UMLS CUI [8]
C0201836
able to understand and give written informed consent and comply with study procedures
Beschrijving

Informed Consent | Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
relapse on treatment with non-steroidal ai after less than 12 months for patients in the adjuvant setting
Beschrijving

Non-Steroidal Aromatase Inhibitor | Recurrent disease | Adjuvant therapy

Datatype

boolean

Alias
UMLS CUI [1]
C1518386
UMLS CUI [2]
C0277556
UMLS CUI [3]
C0677850
progressive disease after less than 3 months treatment with most recent ai for patients with metastatic disease
Beschrijving

Aromatase Inhibitors Neoplasm Metastasis | Progressive Disease

Datatype

boolean

Alias
UMLS CUI [1,1]
C0593802
UMLS CUI [1,2]
C0027627
UMLS CUI [2]
C1335499
rapidly progressive, life-threatening metastases
Beschrijving

Neoplasm Metastasis Life Threatening Rapidly progressive

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C2826244
UMLS CUI [1,3]
C1838681
any palliative radiotherapy to the measurable lesion
Beschrijving

Palliative course of radiotherapy Measurable lesion

Datatype

boolean

Alias
UMLS CUI [1,1]
C0475092
UMLS CUI [1,2]
C1513041
previous treatment with sndx-275 or any other hdac inhibitor including valproic acid
Beschrijving

SNDX-275 | Histone deacetylase inhibitor | Valproic Acid

Datatype

boolean

Alias
UMLS CUI [1]
C4048552
UMLS CUI [2]
C1512474
UMLS CUI [3]
C0042291
allergy to benzamides or inactive components of the study drug
Beschrijving

Hypersensitivity Benzamides | Hypersensitivity Investigational New Drugs inactive ingredient

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0005029
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013230
UMLS CUI [2,3]
C1552019
a history of allergies to any active or inactive ingredients of exemestane
Beschrijving

Hypersensitivity Exemestane Active ingredient | Hypersensitivity Exemestane Inactive ingredient

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0851344
UMLS CUI [1,3]
C1372955
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0851344
UMLS CUI [2,3]
C1552019
any concomitant medical condition that precludes adequate study treatment compliance
Beschrijving

Comorbidity Excludes Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0525058
patient is currently enrolled in (or completed within 30 days before study drug administration) another investigational drug study
Beschrijving

Study Subject Participation Status | Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
patient is currently receiving treatment with valproic acid, zolinza(vorinostat) or any other hdac inhibitor or dna methyltransferase inhibitor or any systemic anticancer treatment (with the exception of lupron)
Beschrijving

Valproic Acid | Zolinza | Vorinostat | Histone deacetylase inhibitor | DNA Methyltransferase Inhibitors | Cancer treatment Systemic | Exception Lupron

Datatype

boolean

Alias
UMLS CUI [1]
C0042291
UMLS CUI [2]
C1738860
UMLS CUI [3]
C0672708
UMLS CUI [4]
C1512474
UMLS CUI [5]
C1511682
UMLS CUI [6,1]
C0920425
UMLS CUI [6,2]
C0205373
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0701459
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Similar models

Eligibility Breast Cancer NCT00676663

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Postmenopausal state
Item
postmenopausal female patients
boolean
C0232970 (UMLS CUI [1])
Oestrogen receptor positive breast cancer
Item
histologically or cytologically confirmed er+ breast cancer
boolean
C2938924 (UMLS CUI [1])
Aromatase Inhibitors | Recurrent disease | Disease Progression
Item
relapsed or progressed on prior treatment with ai
boolean
C0593802 (UMLS CUI [1])
C0277556 (UMLS CUI [2])
C0242656 (UMLS CUI [3])
Neoplasm Metastasis Measurable
Item
metastatic disease must be measurable
boolean
C0027627 (UMLS CUI [1,1])
C1513040 (UMLS CUI [1,2])
Palliative Radiation Therapy Lesion Non-Target | Washout Period Patient need for
Item
patients receiving palliative radiation at the non-target lesions must have a 2 week wash out period following completion of the treatment prior to enrollment
boolean
C3898008 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C1518389 (UMLS CUI [1,3])
C1710661 (UMLS CUI [2,1])
C0686904 (UMLS CUI [2,2])
First line treatment Prior Chemotherapy Quantity | Status pre- Aromatase Inhibitors
Item
patient may have had one prior chemotherapy as part of first line therapy as long as it was received before initiation of prior ai
boolean
C1708063 (UMLS CUI [1,1])
C1514457 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0332152 (UMLS CUI [2,1])
C0593802 (UMLS CUI [2,2])
ECOG performance status
Item
ecog performance status: 0 to 1
boolean
C1520224 (UMLS CUI [1])
Laboratory Results | Hemoglobin measurement | Platelet Count measurement | Absolute neutrophil count | Hematopoietic Growth Factors Absent | Creatinine measurement, serum | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
laboratory parameters: a)hemoglobin ≥ 9.0 g/dl; platelets ≥ 100.0 x 109/l; anc ≥ 1.5 x 109/l without the use of hematopoietic growth factors b)creatinine less than 2.5 times the upper limit of normal for the institution c)ast and alt less than 2.5 times the upper limit of normal for the institution
boolean
C1254595 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0948762 (UMLS CUI [4])
C0079490 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0201976 (UMLS CUI [6])
C0201899 (UMLS CUI [7])
C0201836 (UMLS CUI [8])
Informed Consent | Protocol Compliance
Item
able to understand and give written informed consent and comply with study procedures
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Non-Steroidal Aromatase Inhibitor | Recurrent disease | Adjuvant therapy
Item
relapse on treatment with non-steroidal ai after less than 12 months for patients in the adjuvant setting
boolean
C1518386 (UMLS CUI [1])
C0277556 (UMLS CUI [2])
C0677850 (UMLS CUI [3])
Aromatase Inhibitors Neoplasm Metastasis | Progressive Disease
Item
progressive disease after less than 3 months treatment with most recent ai for patients with metastatic disease
boolean
C0593802 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
C1335499 (UMLS CUI [2])
Neoplasm Metastasis Life Threatening Rapidly progressive
Item
rapidly progressive, life-threatening metastases
boolean
C0027627 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
C1838681 (UMLS CUI [1,3])
Palliative course of radiotherapy Measurable lesion
Item
any palliative radiotherapy to the measurable lesion
boolean
C0475092 (UMLS CUI [1,1])
C1513041 (UMLS CUI [1,2])
SNDX-275 | Histone deacetylase inhibitor | Valproic Acid
Item
previous treatment with sndx-275 or any other hdac inhibitor including valproic acid
boolean
C4048552 (UMLS CUI [1])
C1512474 (UMLS CUI [2])
C0042291 (UMLS CUI [3])
Hypersensitivity Benzamides | Hypersensitivity Investigational New Drugs inactive ingredient
Item
allergy to benzamides or inactive components of the study drug
boolean
C0020517 (UMLS CUI [1,1])
C0005029 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C1552019 (UMLS CUI [2,3])
Hypersensitivity Exemestane Active ingredient | Hypersensitivity Exemestane Inactive ingredient
Item
a history of allergies to any active or inactive ingredients of exemestane
boolean
C0020517 (UMLS CUI [1,1])
C0851344 (UMLS CUI [1,2])
C1372955 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0851344 (UMLS CUI [2,2])
C1552019 (UMLS CUI [2,3])
Comorbidity Excludes Protocol Compliance
Item
any concomitant medical condition that precludes adequate study treatment compliance
boolean
C0009488 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
Study Subject Participation Status | Investigational New Drugs
Item
patient is currently enrolled in (or completed within 30 days before study drug administration) another investigational drug study
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Valproic Acid | Zolinza | Vorinostat | Histone deacetylase inhibitor | DNA Methyltransferase Inhibitors | Cancer treatment Systemic | Exception Lupron
Item
patient is currently receiving treatment with valproic acid, zolinza(vorinostat) or any other hdac inhibitor or dna methyltransferase inhibitor or any systemic anticancer treatment (with the exception of lupron)
boolean
C0042291 (UMLS CUI [1])
C1738860 (UMLS CUI [2])
C0672708 (UMLS CUI [3])
C1512474 (UMLS CUI [4])
C1511682 (UMLS CUI [5])
C0920425 (UMLS CUI [6,1])
C0205373 (UMLS CUI [6,2])
C1705847 (UMLS CUI [7,1])
C0701459 (UMLS CUI [7,2])
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