ID

16500

Beskrivning

Dose Escalation of Bivatuzumab Mertansine in Female Patients With CD44v6 Positive Recurrent or Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02254031

Länk

https://clinicaltrials.gov/show/NCT02254031

Nyckelord

Versioner (1)
  1. 2016-07-19 2016-07-19 -
Uppladdad den

19 juli 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT02254031

Engelsk

Eligibility Breast Neoplasms NCT02254031

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Gender | Age

Datatyp

boolean

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

Breast Carcinoma | Tumor cells CD44v6 Positive

Datatyp

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2,1]
C0431085
UMLS CUI [2,2]
C0675853
UMLS CUI [2,3]
C1446409
3. patients with local and / or regional recurrent disease or distant metastases who are refractory to anthracyclines and / or taxanes (unless contraindications to taxanes and / or anthracyclines) or not amenable to established treatments
Beskrivning

Recurrent disease Local | Recurrent disease regional | distant metastases | Anthracycline Refractory | Taxanes Refractory | Medical contraindication Taxanes | Medical contraindication Anthracycline | Standard therapy Amenable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0277556
UMLS CUI [1,2]
C0205276
UMLS CUI [2,1]
C0277556
UMLS CUI [2,2]
C0205147
UMLS CUI [3]
C3258247
UMLS CUI [4,1]
C0003234
UMLS CUI [4,2]
C0205269
UMLS CUI [5,1]
C3541958
UMLS CUI [5,2]
C0205269
UMLS CUI [6,1]
C1301624
UMLS CUI [6,2]
C3541958
UMLS CUI [7,1]
C1301624
UMLS CUI [7,2]
C0003234
UMLS CUI [8,1]
C2936643
UMLS CUI [8,2]
C3900053
4. measurable tumour deposits by one or more radiological techniques (mri, ct)
Beskrivning

Neoplasm Measurable | Radiology techniques | Magnetic Resonance Imaging | X-Ray Computed Tomography

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C1513040
UMLS CUI [2]
C0457276
UMLS CUI [3]
C0024485
UMLS CUI [4]
C0040405
5. life expectancy of at least 6 months
Beskrivning

Life Expectancy

Datatyp

boolean

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

ECOG performance status

Datatyp

boolean

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

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

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

Hypersensitivity Antibodies, Monoclonal, Humanized | Hypersensitivity Antibodies, Monoclonal, Murine-Derived | Hypersensitivity Immunoconjugates | Hypersensitivity Investigational New Drugs Excipient

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2985546
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C2916903
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0243020
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0013230
UMLS CUI [4,3]
C0015237
2. known secondary malignancy requiring therapy
Beskrivning

Secondary Malignant Neoplasm Requirement Therapeutic procedure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3266877
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0087111
3. active infectious disease
Beskrivning

Communicable Diseases

Datatyp

boolean

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

Metastatic malignant neoplasm to brain Requirement Therapeutic procedure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0087111
5. neuropathy grade 2 or above
Beskrivning

Neuropathy | CTCAE

Datatyp

boolean

Alias
UMLS CUI [1]
C0442874
UMLS CUI [2]
C1516728
6. absolute neutrophil count less than 1,500/mm3
Beskrivning

Absolute neutrophil count

Datatyp

boolean

Alias
UMLS CUI [1]
C0948762
7. platelet count less than 100,000/mm3
Beskrivning

Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0032181
8. bilirubin greater than 1.5 mg/dl (> 26 μmol/l, système internationale (si) unit equivalent)
Beskrivning

Serum total bilirubin measurement

Datatyp

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
Beskrivning

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
10. serum creatinine greater than 1.5 mg/dl (> 132 μmol/l, si unit equivalent)
Beskrivning

Creatinine measurement, serum

Datatyp

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
Beskrivning

Comorbidity Non-Malignant | Evaluation Trial drug safety

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C1518371
UMLS CUI [2,1]
C1261322
UMLS CUI [2,2]
C0008976
UMLS CUI [2,3]
C0678800
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)
Beskrivning

Chemotherapy | Immunotherapy | Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0021083
UMLS CUI [3]
C0013230
13. radiotherapy to breast and thorax region within the past four weeks prior to treatment with the trial drug or during the trial
Beskrivning

Therapeutic radiology procedure Region of breast | Therapeutic radiology procedure Region of thorax | Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0230109
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C1959676
UMLS CUI [3]
C0013230
14. women who are sexually active and unwilling to use a medically acceptable method of contraception
Beskrivning

Gender Sexually active | Contraceptive methods Unwilling

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0241028
UMLS CUI [2,1]
C0700589
UMLS CUI [2,2]
C0558080
15. pregnancy or lactation
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [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)
Beskrivning

Investigational New Drugs | Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C2348568
17. patients unable to comply with the protocol
Beskrivning

Study Protocol Compliance behavior Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C1321605
UMLS CUI [1,3]
C1299582
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Similar models

Eligibility Breast Neoplasms NCT02254031

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
1. female patients aged 18 years or older
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Breast Carcinoma | Tumor cells CD44v6 Positive
Item
2. patients with breast cancer positive for cd44v6 in at least 50 % of the tumour cells
boolean
C0678222 (UMLS CUI [1])
C0431085 (UMLS CUI [2,1])
C0675853 (UMLS CUI [2,2])
C1446409 (UMLS CUI [2,3])
Recurrent disease Local | Recurrent disease regional | distant metastases | Anthracycline Refractory | Taxanes Refractory | Medical contraindication Taxanes | Medical contraindication Anthracycline | Standard therapy Amenable
Item
3. patients with local and / or regional recurrent disease or distant metastases who are refractory to anthracyclines and / or taxanes (unless contraindications to taxanes and / or anthracyclines) or not amenable to established treatments
boolean
C0277556 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0277556 (UMLS CUI [2,1])
C0205147 (UMLS CUI [2,2])
C3258247 (UMLS CUI [3])
C0003234 (UMLS CUI [4,1])
C0205269 (UMLS CUI [4,2])
C3541958 (UMLS CUI [5,1])
C0205269 (UMLS CUI [5,2])
C1301624 (UMLS CUI [6,1])
C3541958 (UMLS CUI [6,2])
C1301624 (UMLS CUI [7,1])
C0003234 (UMLS CUI [7,2])
C2936643 (UMLS CUI [8,1])
C3900053 (UMLS CUI [8,2])
Neoplasm Measurable | Radiology techniques | Magnetic Resonance Imaging | X-Ray Computed Tomography
Item
4. measurable tumour deposits by one or more radiological techniques (mri, ct)
boolean
C0027651 (UMLS CUI [1,1])
C1513040 (UMLS CUI [1,2])
C0457276 (UMLS CUI [2])
C0024485 (UMLS CUI [3])
C0040405 (UMLS CUI [4])
Life Expectancy
Item
5. life expectancy of at least 6 months
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
6. eastern cooperative oncology group (ecog) performance score ≤ 2
boolean
C1520224 (UMLS CUI [1])
Informed Consent
Item
7. patients must have given written informed consent (which must be consistent with international conference of harmonisation-good clinical practice (ich-gcp) and local legislation)
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Antibodies, Monoclonal, Humanized | Hypersensitivity Antibodies, Monoclonal, Murine-Derived | Hypersensitivity Immunoconjugates | Hypersensitivity Investigational New Drugs Excipient
Item
1. hypersensitivity to humanised or murine antibodies, immunoconjugates or the excipients of the trial drugs
boolean
C0020517 (UMLS CUI [1,1])
C2985546 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C2916903 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0243020 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0013230 (UMLS CUI [4,2])
C0015237 (UMLS CUI [4,3])
Secondary Malignant Neoplasm Requirement Therapeutic procedure
Item
2. known secondary malignancy requiring therapy
boolean
C3266877 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
Communicable Diseases
Item
3. active infectious disease
boolean
C0009450 (UMLS CUI [1])
Metastatic malignant neoplasm to brain Requirement Therapeutic procedure
Item
4. brain metastases requiring therapy
boolean
C0220650 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
Neuropathy | CTCAE
Item
5. neuropathy grade 2 or above
boolean
C0442874 (UMLS CUI [1])
C1516728 (UMLS CUI [2])
Absolute neutrophil count
Item
6. absolute neutrophil count less than 1,500/mm3
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
7. platelet count less than 100,000/mm3
boolean
C0032181 (UMLS CUI [1])
Serum total bilirubin measurement
Item
8. bilirubin greater than 1.5 mg/dl (> 26 μmol/l, système internationale (si) unit equivalent)
boolean
C1278039 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
9. aspartate amino transferase (ast) and/or alanine amino transferase (alt) greater than 3 times the upper limit of normal
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Creatinine measurement, serum
Item
10. serum creatinine greater than 1.5 mg/dl (> 132 μmol/l, si unit equivalent)
boolean
C0201976 (UMLS CUI [1])
Comorbidity Non-Malignant | Evaluation Trial drug safety
Item
11. concomitant non-oncological diseases which are considered relevant for the evaluation of the safety of the trial drug
boolean
C0009488 (UMLS CUI [1,1])
C1518371 (UMLS CUI [1,2])
C1261322 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
C0678800 (UMLS CUI [2,3])
Chemotherapy | Immunotherapy | Investigational New Drugs
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
C0392920 (UMLS CUI [1])
C0021083 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
Therapeutic radiology procedure Region of breast | Therapeutic radiology procedure Region of thorax | Investigational New Drugs
Item
13. radiotherapy to breast and thorax region within the past four weeks prior to treatment with the trial drug or during the trial
boolean
C1522449 (UMLS CUI [1,1])
C0230109 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C1959676 (UMLS CUI [2,2])
C0013230 (UMLS CUI [3])
Gender Sexually active | Contraceptive methods Unwilling
Item
14. women who are sexually active and unwilling to use a medically acceptable method of contraception
boolean
C0079399 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C0700589 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
15. pregnancy or lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Investigational New Drugs | Study Subject Participation Status
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
C0013230 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
Study Protocol Compliance behavior Unable
Item
17. patients unable to comply with the protocol
boolean
C2348563 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
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