ID

15081

Descripción

Single Dose Escalation Study of Bivatuzumab Mertansine in Female Patients With CD44v6 Positive Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02254005

Link

https://clinicaltrials.gov/show/NCT02254005

Palabras clave

Versiones (3)
  1. 15/5/16 15/5/16 -
  2. 18/6/16 18/6/16 -
  3. 18/6/16 18/6/16 -
Subido en

15 de mayo de 2016

DOI

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Licencia

Creative Commons BY-NC 3.0
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Eligibility Breast Neoplasms NCT02254005

Inglés

Eligibility Breast Neoplasms NCT02254005

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. female patients aged 18 years or older
Descripción

ID.1

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C0079399
2. patients with breast cancer positive for cd44v6 in at least 50 % of the tumour cells
Descripción

ID.2

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0675853
UMLS CUI [1,2]
C1446409
3. patients with metastases pretreated with anthracyclines and taxanes (unless contraindications to taxanes and / or anthracyclines) or not amenable to established treatments
Descripción

ID.3

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2709094
UMLS CUI [1,2]
C0282564|C3541958
4. measurable tumour deposits by one or more radiological techniques (mri, ct)
Descripción

ID.4

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C1513040
5. life expectancy of at least 6 months
Descripción

ID.5

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023671
6. eastern cooperative oncology group (ecog) performance score ≤ 2
Descripción

ID.6

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
7. patients must have given written informed consent (which must be consistent with international conference on harmonisation-good clinical practice (ich-gcp) and local legislation)
Descripción

ID.7

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. hypersensitivity to humanised or murine antibodies, immunoconjugates or the excipients of the trial drugs
Descripción

ID.8

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0003241|C0243020|C0015237
2. known secondary malignancy requiring therapy
Descripción

ID.9

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3266877
3. active infectious disease
Descripción

ID.10

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009450
4. brain metastases requiring therapy
Descripción

ID.11

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0220650
5. neuropathy common toxicity criteria (ctc) grade 2 or above
Descripción

ID.12

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1516728
6. absolute neutrophil count less than 1,500/mm3
Descripción

ID.13

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0200633
7. platelet count less than 100,000/mm3
Descripción

ID.14

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0005821
8. bilirubin greater than 1.5 mg/dl (> 26 μmol/l, système internationale (si) unit equivalent)
Descripción

ID.15

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1278039
9. aspartate amino transferase (ast) and/or alanine amino transferase (alt) greater than 3 times the upper limit of normal
Descripción

ID.16

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0004002
UMLS CUI [1,2]
C0001899
UMLS CUI [1,3]
C1519815
10. serum creatinine greater than 1.5 mg/dl (> 132 μmol/l, si unit equivalent)
Descripción

ID.17

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201976
11. concomitant non-oncological diseases which are considered relevant for the evaluation of the safety of the trial drug
Descripción

ID.18

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201976
12. chemo- or immunotherapy within the past four weeks prior to treatment with the trial drug or during the trial (except for present trial drug)
Descripción

ID.19

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1514457|C1514461
13. radiotherapy to breast and thorax region within the past four weeks before inclusion or during the trial
Descripción

ID.20

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C3828653
14. women who are sexually active and unwilling to use a medically acceptable method of contraception
Descripción

ID.21

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0241028
UMLS CUI [1,2]
C0700589
15. pregnancy or lactation
Descripción

ID.22

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
16. treatment with other investigational drugs or participation in another clinical trial within the past four weeks before start of therapy or concomitantly with this trial (except for present trial drug)
Descripción

ID.23

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
17. patients unable to comply with the protocol
Descripción

ID.24

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1321605
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Similar models

Eligibility Breast Neoplasms NCT02254005

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
1. female patients aged 18 years or older
boolean
C0001779 (UMLS CUI [1,1])
C0079399 (UMLS CUI [1,2])
ID.2
Item
2. patients with breast cancer positive for cd44v6 in at least 50 % of the tumour cells
boolean
C0675853 (UMLS CUI [1,1])
C1446409 (UMLS CUI [1,2])
ID.3
Item
3. patients with metastases pretreated with anthracyclines and taxanes (unless contraindications to taxanes and / or anthracyclines) or not amenable to established treatments
boolean
C2709094 (UMLS CUI [1,1])
C0282564|C3541958 (UMLS CUI [1,2])
ID.4
Item
4. measurable tumour deposits by one or more radiological techniques (mri, ct)
boolean
C0006826 (UMLS CUI [1,1])
C1513040 (UMLS CUI [1,2])
ID.5
Item
5. life expectancy of at least 6 months
boolean
C0023671 (UMLS CUI [1])
ID.6
Item
6. eastern cooperative oncology group (ecog) performance score ≤ 2
boolean
C1520224 (UMLS CUI [1])
ID.7
Item
7. patients must have given written informed consent (which must be consistent with international conference on harmonisation-good clinical practice (ich-gcp) and local legislation)
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
ID.8
Item
1. hypersensitivity to humanised or murine antibodies, immunoconjugates or the excipients of the trial drugs
boolean
C0020517 (UMLS CUI [1,1])
C0003241|C0243020|C0015237 (UMLS CUI [1,2])
ID.9
Item
2. known secondary malignancy requiring therapy
boolean
C3266877 (UMLS CUI [1])
ID.10
Item
3. active infectious disease
boolean
C0009450 (UMLS CUI [1])
ID.11
Item
4. brain metastases requiring therapy
boolean
C0220650 (UMLS CUI [1])
ID.12
Item
5. neuropathy common toxicity criteria (ctc) grade 2 or above
boolean
C1516728 (UMLS CUI [1])
ID.13
Item
6. absolute neutrophil count less than 1,500/mm3
boolean
C0200633 (UMLS CUI [1])
ID.14
Item
7. platelet count less than 100,000/mm3
boolean
C0005821 (UMLS CUI [1])
ID.15
Item
8. bilirubin greater than 1.5 mg/dl (> 26 μmol/l, système internationale (si) unit equivalent)
boolean
C1278039 (UMLS CUI [1])
ID.16
Item
9. aspartate amino transferase (ast) and/or alanine amino transferase (alt) greater than 3 times the upper limit of normal
boolean
C0004002 (UMLS CUI [1,1])
C0001899 (UMLS CUI [1,2])
C1519815 (UMLS CUI [1,3])
ID.17
Item
10. serum creatinine greater than 1.5 mg/dl (> 132 μmol/l, si unit equivalent)
boolean
C0201976 (UMLS CUI [1])
ID.18
Item
11. concomitant non-oncological diseases which are considered relevant for the evaluation of the safety of the trial drug
boolean
C0201976 (UMLS CUI [1])
ID.19
Item
12. chemo- or immunotherapy within the past four weeks prior to treatment with the trial drug or during the trial (except for present trial drug)
boolean
C1514457|C1514461 (UMLS CUI [1])
ID.20
Item
13. radiotherapy to breast and thorax region within the past four weeks before inclusion or during the trial
boolean
C1522449 (UMLS CUI [1,1])
C3828653 (UMLS CUI [1,2])
ID.21
Item
14. women who are sexually active and unwilling to use a medically acceptable method of contraception
boolean
C0241028 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
ID.22
Item
15. pregnancy or lactation
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
ID.23
Item
16. treatment with other investigational drugs or participation in another clinical trial within the past four weeks before start of therapy or concomitantly with this trial (except for present trial drug)
boolean
C2348568 (UMLS CUI [1])
ID.24
Item
17. patients unable to comply with the protocol
boolean
C1321605 (UMLS CUI [1])
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