ID

26215

Description

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

Lien

https://clinicaltrials.gov/show/NCT00676663

Mots-clés

Versions (1)
  1. 11/10/2017 11/10/2017 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

11 octobre 2017

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00676663

Anglais

Eligibility Breast Cancer NCT00676663

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
postmenopausal female patients
Description

Postmenopausal state

Type de données

boolean

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

Oestrogen receptor positive breast cancer

Type de données

boolean

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

Aromatase Inhibitors | Recurrent disease | Disease Progression

Type de données

boolean

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

Neoplasm Metastasis Measurable

Type de données

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
Description

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

Type de données

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
Description

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

Type de données

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
Description

ECOG performance status

Type de données

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
Description

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

Type de données

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
Description

Informed Consent | Protocol Compliance

Type de données

boolean

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

Exclusion Criteria

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

Non-Steroidal Aromatase Inhibitor | Recurrent disease | Adjuvant therapy

Type de données

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
Description

Aromatase Inhibitors Neoplasm Metastasis | Progressive Disease

Type de données

boolean

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

Neoplasm Metastasis Life Threatening Rapidly progressive

Type de données

boolean

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

Palliative course of radiotherapy Measurable lesion

Type de données

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
Description

SNDX-275 | Histone deacetylase inhibitor | Valproic Acid

Type de données

boolean

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

Hypersensitivity Benzamides | Hypersensitivity Investigational New Drugs inactive ingredient

Type de données

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
Description

Hypersensitivity Exemestane Active ingredient | Hypersensitivity Exemestane Inactive ingredient

Type de données

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
Description

Comorbidity Excludes Protocol Compliance

Type de données

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
Description

Study Subject Participation Status | Investigational New Drugs

Type de données

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)
Description

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

Type de données

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 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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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