ID

15923

Description

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

Keywords

Versions (3)
  1. 5/15/16 5/15/16 -
  2. 6/18/16 6/18/16 -
  3. 6/18/16 6/18/16 -
Uploaded on

June 18, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT02254005

English

Eligibility Breast Neoplasms NCT02254005

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

age and gender

Data type

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
Description

breast cancer positive for cd44v6

Data type

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
Description

ID.3

Data type

boolean

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

measurable tumour deposits

Data type

boolean

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

life expectancy

Data type

boolean

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

ecog performance

Data type

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)
Description

written informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

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

hypersensitivity to the trial drug

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0003241
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0243020
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0015237
2. known secondary malignancy requiring therapy
Description

secondary malignancy

Data type

boolean

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

active infectious disease

Data type

boolean

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

brain metastases

Data type

boolean

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

ctc grade

Data type

boolean

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

neutrophil count

Data type

boolean

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

platelet count

Data type

boolean

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

bilirubin measurement

Data type

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
Description

AST or ALT

Data type

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)
Description

serum creatinine

Data type

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
Description

concomitant non-oncological diseases

Data type

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)
Description

prior chemo- or immunotherapy

Data type

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2]
C1514461
13. radiotherapy to breast and thorax region within the past four weeks before inclusion or during the trial
Description

prior radiotherapy to breast and thorax

Data type

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
Description

sexually active and unwilling for suitable contraception

Data type

boolean

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

pregnancy or lactation

Data type

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)
Description

participation in another clinical trial

Data type

boolean

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

patient compliance

Data type

boolean

Alias
UMLS CUI [1]
C1321605
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Similar models

Eligibility Breast Neoplasms NCT02254005

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
age and gender
Item
1. female patients aged 18 years or older
boolean
C0001779 (UMLS CUI [1,1])
C0079399 (UMLS CUI [1,2])
breast cancer positive for cd44v6
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 (UMLS CUI [1,2])
C2709094 (UMLS CUI [2,1])
C3541958 (UMLS CUI [2,2])
measurable tumour deposits
Item
4. measurable tumour deposits by one or more radiological techniques (mri, ct)
boolean
C0006826 (UMLS CUI [1,1])
C1513040 (UMLS CUI [1,2])
life expectancy
Item
5. life expectancy of at least 6 months
boolean
C0023671 (UMLS CUI [1])
ecog performance
Item
6. eastern cooperative oncology group (ecog) performance score ≤ 2
boolean
C1520224 (UMLS CUI [1])
written informed consent
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)
hypersensitivity to the trial drug
Item
1. hypersensitivity to humanised or murine antibodies, immunoconjugates or the excipients of the trial drugs
boolean
C0020517 (UMLS CUI [1,1])
C0003241 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0243020 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0015237 (UMLS CUI [3,2])
secondary malignancy
Item
2. known secondary malignancy requiring therapy
boolean
C3266877 (UMLS CUI [1])
active infectious disease
Item
3. active infectious disease
boolean
C0009450 (UMLS CUI [1])
brain metastases
Item
4. brain metastases requiring therapy
boolean
C0220650 (UMLS CUI [1])
ctc grade
Item
5. neuropathy common toxicity criteria (ctc) grade 2 or above
boolean
C1516728 (UMLS CUI [1])
neutrophil count
Item
6. absolute neutrophil count less than 1,500/mm3
boolean
C0200633 (UMLS CUI [1])
platelet count
Item
7. platelet count less than 100,000/mm3
boolean
C0005821 (UMLS CUI [1])
bilirubin measurement
Item
8. bilirubin greater than 1.5 mg/dl (> 26 μmol/l, système internationale (si) unit equivalent)
boolean
C1278039 (UMLS CUI [1])
AST or ALT
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])
serum creatinine
Item
10. serum creatinine greater than 1.5 mg/dl (> 132 μmol/l, si unit equivalent)
boolean
C0201976 (UMLS CUI [1])
concomitant non-oncological diseases
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])
prior chemo- or immunotherapy
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 (UMLS CUI [1])
C1514461 (UMLS CUI [2])
prior radiotherapy to breast and thorax
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])
sexually active and unwilling for suitable contraception
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])
pregnancy or lactation
Item
15. pregnancy or lactation
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
participation in another clinical trial
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])
patient compliance
Item
17. patients unable to comply with the protocol
boolean
C1321605 (UMLS CUI [1])
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