ID

16537

Beschrijving

Dose Escalation of Bivatuzumab Mertansine in Patients With Advanced Squamous Cell Carcinoma of the Head and Neck or Esophagus; ODM derived from: https://clinicaltrials.gov/show/NCT02254044

Link

https://clinicaltrials.gov/show/NCT02254044

Trefwoorden

Versies (1)
  1. 23-07-16 23-07-16 -
Geüploaded op

23 juli 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Carcinoma, Squamous Cell NCT02254044

Engels

Eligibility Carcinoma, Squamous Cell NCT02254044

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients from 18 to 80 years of age (both inclusive)
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
2. patients with histologically confirmed squamous cell carcinoma of the head and neck or esophagus
Beschrijving

Squamous cell carcinoma of the head and neck | Squamous cell carcinoma of esophagus

Datatype

boolean

Alias
UMLS CUI [1]
C1168401
UMLS CUI [2]
C0279626
3. patients with local and / or regional recurrent disease or distant metastases who are refractory to or not amenable to established treatments
Beschrijving

Recurrent disease Local | Recurrent disease regional | Status of distant metastasis | Treatment Resistant Disorder | Disease Therapeutic procedure Amenable

Datatype

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]
C1302548
UMLS CUI [4]
C0871547
UMLS CUI [5,1]
C0012634
UMLS CUI [5,2]
C0087111
UMLS CUI [5,3]
C3900053
4. evaluable tumour deposits
Beschrijving

Tumor fragments Evaluable

Datatype

boolean

Alias
UMLS CUI [1,1]
C1298181
UMLS CUI [1,2]
C1516986
5. life expectancy of at least 3 months
Beschrijving

Life Expectancy

Datatype

boolean

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

ECOG performance status

Datatype

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)
Beschrijving

Informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

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

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

Datatype

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
Beschrijving

Secondary Malignant Neoplasm Requirement Therapeutic procedure

Datatype

boolean

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

Communicable Disease

Datatype

boolean

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

Metastatic malignant neoplasm to brain Requirement Therapeutic procedure

Datatype

boolean

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

Neuropathy Grade

Datatype

boolean

Alias
UMLS CUI [1,1]
C0442874
UMLS CUI [1,2]
C0441800
6. absolute neutrophil count less than 1,500/mm3
Beschrijving

Absolute neutrophil count

Datatype

boolean

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

Platelet Count measurement

Datatype

boolean

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

Serum total bilirubin measurement

Datatype

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
Beschrijving

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datatype

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)
Beschrijving

Creatinine measurement, serum

Datatype

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
Beschrijving

Comorbidity Relevant Evaluation drug safety

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C2347946
UMLS CUI [1,3]
C1261322
UMLS CUI [1,4]
C0678800
12. chemo-, radio- or immunotherapy within the past four weeks prior to treatment with the trial drug or during the trial (except for present trial drug)
Beschrijving

Chemotherapy | Therapeutic radiology procedure | Immunotherapy | Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0021083
UMLS CUI [4]
C0013230
13. men and women who are sexually active and unwilling to use a medically acceptable method of contraception
Beschrijving

Gender Sexually active | Contraceptive methods Unwilling

Datatype

boolean

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

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
15. 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)
Beschrijving

Investigational New Drugs | Study Subject Participation Status

Datatype

boolean

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

Study Protocol Compliance behavior Unable

Datatype

boolean

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

Eligibility Carcinoma, Squamous Cell NCT02254044

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. patients from 18 to 80 years of age (both inclusive)
boolean
C0001779 (UMLS CUI [1])
Squamous cell carcinoma of the head and neck | Squamous cell carcinoma of esophagus
Item
2. patients with histologically confirmed squamous cell carcinoma of the head and neck or esophagus
boolean
C1168401 (UMLS CUI [1])
C0279626 (UMLS CUI [2])
Recurrent disease Local | Recurrent disease regional | Status of distant metastasis | Treatment Resistant Disorder | Disease Therapeutic procedure Amenable
Item
3. patients with local and / or regional recurrent disease or distant metastases who are refractory to 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])
C1302548 (UMLS CUI [3])
C0871547 (UMLS CUI [4])
C0012634 (UMLS CUI [5,1])
C0087111 (UMLS CUI [5,2])
C3900053 (UMLS CUI [5,3])
Tumor fragments Evaluable
Item
4. evaluable tumour deposits
boolean
C1298181 (UMLS CUI [1,1])
C1516986 (UMLS CUI [1,2])
Life Expectancy
Item
5. life expectancy of at least 3 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 on 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 Disease
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 Grade
Item
5. neuropathy grade 2 or above
boolean
C0442874 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
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 Relevant Evaluation 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])
C2347946 (UMLS CUI [1,2])
C1261322 (UMLS CUI [1,3])
C0678800 (UMLS CUI [1,4])
Chemotherapy | Therapeutic radiology procedure | Immunotherapy | Investigational New Drugs
Item
12. chemo-, radio- 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])
C1522449 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
C0013230 (UMLS CUI [4])
Gender Sexually active | Contraceptive methods Unwilling
Item
13. men and 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
14. pregnancy or lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Investigational New Drugs | Study Subject Participation Status
Item
15. 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
16. 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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