ID

39894

Beschrijving

Dovitinib(TKI258) in Patients With Castration-resistant Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01741116

Link

https://clinicaltrials.gov/show/NCT01741116

Trefwoorden

Versies (1)
  1. 01-03-20 01-03-20 -
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See clinicaltrials.gov

Geüploaded op

1 maart 2020

DOI

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Creative Commons BY 4.0
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Eligibility Hormone Refractory Prostate Cancer NCT01741116

Engels

Eligibility Hormone Refractory Prostate Cancer NCT01741116

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with histologically confirmed progressive metastatic androgen-independent adenocarcinoma of the prostate with radiographic evidence of disease.
Beschrijving

Adenocarcinoma of the prostate metastatic Progressive Androgen-independent | Disease Radiography

Datatype

boolean

Alias
UMLS CUI [1,1]
C0862636
UMLS CUI [1,2]
C0205329
UMLS CUI [1,3]
C2986466
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0043299
no more than two previous cytotoxic chemotherapy
Beschrijving

Cytotoxic Chemotherapy Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0677881
UMLS CUI [1,2]
C1265611
castration level of testosterone (< 50 ng/dl) achieved by orchiectomy or gonadotropin-releasing hormone(gnrh) agonist
Beschrijving

Castration Levels of Testosterone | Orchiectomy | Gonadotropin Releasing Hormone Agonist

Datatype

boolean

Alias
UMLS CUI [1]
C4289828
UMLS CUI [2]
C0029189
UMLS CUI [3]
C2267073
eastern cooperative oncology group(ecog) performance status 0 - 2
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
finished any study drug or chemotherapy earlier than 4 weeks before the first administration of the study drug.
Beschrijving

Investigational New Drugs Treatment completed | Chemotherapy Completed

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0580352
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0205197
age ≥ 20 years old
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
patients must have the following laboratory values:
Beschrijving

Laboratory Results Required

Datatype

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C1514873
absolute neutrophil count (anc) ≥ 1.5 x 109/l
Beschrijving

Absolute neutrophil count

Datatype

boolean

Alias
UMLS CUI [1]
C0948762
platelets ≥ 75 x 109/l
Beschrijving

Platelet Count measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0032181
hemoglobin (hgb) > 8 g/dl
Beschrijving

Hemoglobin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0518015
serum total bilirubin: ≤ 1.5 x uln
Beschrijving

Serum total bilirubin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C1278039
alanine transaminase(alt) and aspartate aminotransferase(ast) ≤ 2.0 x upper limit of normal(uln) with or without liver metastases
Beschrijving

Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Secondary malignant neoplasm of liver | Secondary malignant neoplasm of liver Absent

Datatype

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0494165
UMLS CUI [4,1]
C0494165
UMLS CUI [4,2]
C0332197
serum creatinine ≤ 1.5 x uln or serum creatinine >1.5 - 3 x uln or 1.5 x uln<serum creatinine < 3 x uln, if calculated creatinine clearance (crcl) is ≥
Beschrijving

Creatinine measurement, serum

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
30 ml/min using the cockcroft-gault equation, see formula below:
Beschrijving

Estimation of creatinine clearance by Cockcroft-Gault formula

Datatype

boolean

Alias
UMLS CUI [1]
C2711451
crcl = [140-age (years)] x weight (kg) / [72 x serum cr (mg/dl)] (if patient is female multiply the above by 0.85)
Beschrijving

Estimation of creatinine clearance by Cockcroft-Gault formula | Gender

Datatype

boolean

Alias
UMLS CUI [1]
C2711451
UMLS CUI [2]
C0079399
patients who give a written informed consent obtained according to local guidelines
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients eligible for this study must not meet any of the following criteria
Beschrijving

Exclusion Criteria Any

Datatype

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1552551
patients with known brain metastases or who have signs/symptoms attributable to brain metastases and have not been assessed with radiologic imaging to rule out the presence of brain metastases
Beschrijving

Metastatic malignant neoplasm to brain | Sign or Symptom Metastatic malignant neoplasm to brain | Radiologic Imaging Procedure Absent

Datatype

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2,1]
C3540840
UMLS CUI [2,2]
C0220650
UMLS CUI [3,1]
C3897780
UMLS CUI [3,2]
C0332197
patients with another primary malignancy within 3 years prior to starting study drug, with the exception of adequately treated in-situ carcinoma of the uterine cervix, basal or squamous cell carcinoma or non-melanomatous skin cancer
Beschrijving

Cancer Other | Exception Carcinoma in situ of uterine cervix Treated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma Treated | Exception Skin carcinoma Treated

Datatype

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0851140
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0007137
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0699893
UMLS CUI [5,3]
C1522326
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Similar models

Eligibility Hormone Refractory Prostate Cancer NCT01741116

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of the prostate metastatic Progressive Androgen-independent | Disease Radiography
Item
patients with histologically confirmed progressive metastatic androgen-independent adenocarcinoma of the prostate with radiographic evidence of disease.
boolean
C0862636 (UMLS CUI [1,1])
C0205329 (UMLS CUI [1,2])
C2986466 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C0043299 (UMLS CUI [2,2])
Cytotoxic Chemotherapy Quantity
Item
no more than two previous cytotoxic chemotherapy
boolean
C0677881 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Castration Levels of Testosterone | Orchiectomy | Gonadotropin Releasing Hormone Agonist
Item
castration level of testosterone (< 50 ng/dl) achieved by orchiectomy or gonadotropin-releasing hormone(gnrh) agonist
boolean
C4289828 (UMLS CUI [1])
C0029189 (UMLS CUI [2])
C2267073 (UMLS CUI [3])
ECOG performance status
Item
eastern cooperative oncology group(ecog) performance status 0 - 2
boolean
C1520224 (UMLS CUI [1])
Investigational New Drugs Treatment completed | Chemotherapy Completed
Item
finished any study drug or chemotherapy earlier than 4 weeks before the first administration of the study drug.
boolean
C0013230 (UMLS CUI [1,1])
C0580352 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
Age
Item
age ≥ 20 years old
boolean
C0001779 (UMLS CUI [1])
Laboratory Results Required
Item
patients must have the following laboratory values:
boolean
C1254595 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
Absolute neutrophil count
Item
absolute neutrophil count (anc) ≥ 1.5 x 109/l
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelets ≥ 75 x 109/l
boolean
C0032181 (UMLS CUI [1])
Hemoglobin measurement
Item
hemoglobin (hgb) > 8 g/dl
boolean
C0518015 (UMLS CUI [1])
Serum total bilirubin measurement
Item
serum total bilirubin: ≤ 1.5 x uln
boolean
C1278039 (UMLS CUI [1])
Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Secondary malignant neoplasm of liver | Secondary malignant neoplasm of liver Absent
Item
alanine transaminase(alt) and aspartate aminotransferase(ast) ≤ 2.0 x upper limit of normal(uln) with or without liver metastases
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0494165 (UMLS CUI [3])
C0494165 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Creatinine measurement, serum
Item
serum creatinine ≤ 1.5 x uln or serum creatinine >1.5 - 3 x uln or 1.5 x uln<serum creatinine < 3 x uln, if calculated creatinine clearance (crcl) is ≥
boolean
C0201976 (UMLS CUI [1])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
30 ml/min using the cockcroft-gault equation, see formula below:
boolean
C2711451 (UMLS CUI [1])
Estimation of creatinine clearance by Cockcroft-Gault formula | Gender
Item
crcl = [140-age (years)] x weight (kg) / [72 x serum cr (mg/dl)] (if patient is female multiply the above by 0.85)
boolean
C2711451 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Informed Consent
Item
patients who give a written informed consent obtained according to local guidelines
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Exclusion Criteria Any
Item
patients eligible for this study must not meet any of the following criteria
boolean
C0680251 (UMLS CUI [1,1])
C1552551 (UMLS CUI [1,2])
Metastatic malignant neoplasm to brain | Sign or Symptom Metastatic malignant neoplasm to brain | Radiologic Imaging Procedure Absent
Item
patients with known brain metastases or who have signs/symptoms attributable to brain metastases and have not been assessed with radiologic imaging to rule out the presence of brain metastases
boolean
C0220650 (UMLS CUI [1])
C3540840 (UMLS CUI [2,1])
C0220650 (UMLS CUI [2,2])
C3897780 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Cancer Other | Exception Carcinoma in situ of uterine cervix Treated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma Treated | Exception Skin carcinoma Treated
Item
patients with another primary malignancy within 3 years prior to starting study drug, with the exception of adequately treated in-situ carcinoma of the uterine cervix, basal or squamous cell carcinoma or non-melanomatous skin cancer
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0007137 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0699893 (UMLS CUI [5,2])
C1522326 (UMLS CUI [5,3])
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