ID

31571

Beschrijving

Efficacy and Safety Study of Panobinostat in Patients With Metastatic Hormone Refractory Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00667862

Link

https://clinicaltrials.gov/show/NCT00667862

Trefwoorden

Versies (1)
  1. 05-09-18 05-09-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

5 september 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00667862

Engels

Eligibility Prostate Cancer NCT00667862

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
confirmed diagnosis of adenocarcinoma of the prostate
Beschrijving

Adenocarcinoma of prostate

Datatype

boolean

Alias
UMLS CUI [1]
C0007112
patients with metastatic hormone refractory prostate cancer
Beschrijving

Hormone refractory prostate cancer metastatic

Datatype

boolean

Alias
UMLS CUI [1,1]
C1328504
UMLS CUI [1,2]
C1522484
patients that have had at least one, but not more than two prior cytotoxic treatments for prostate cancer
Beschrijving

Cytotoxic therapy Quantity Prostate carcinoma

Datatype

boolean

Alias
UMLS CUI [1,1]
C0677881
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0600139
evidence of disease progression by at least one of the following
Beschrijving

Disease Progression | Criteria Quantity

Datatype

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2,1]
C0243161
UMLS CUI [2,2]
C1265611
1. two or more lesions on bone scan
Beschrijving

Lesion Quantity Bone scan

Datatype

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0203668
2. progressive measurable disease
Beschrijving

Measurable Disease Progressive

Datatype

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0205329
3. two documented increases in psa
Beschrijving

Raised prostate specific antigen Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0178415
UMLS CUI [1,2]
C1265611
willing to use contraception throughout the study and for 12 weeks after study completion
Beschrijving

Contraceptive methods Willing

Datatype

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0600109
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
history or clinical signs of cns disease
Beschrijving

Sign or Symptom CNS disorder

Datatype

boolean

Alias
UMLS CUI [1,1]
C3540840
UMLS CUI [1,2]
C0007682
history of other cancers not curatively treated with no evidence of disease for more than 5 years
Beschrijving

Cancer Other Disease length | Curative treatment Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C1707251
UMLS CUI [1,2]
C0872146
UMLS CUI [2,1]
C1273390
UMLS CUI [2,2]
C0332197
prior radiotherapy within 3 weeks of starting study treatment
Beschrijving

Prior radiation therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0279134
prior radiopharmaceuticals (strontium, samarium)
Beschrijving

Radiopharmaceuticals | Strontium | Samarium

Datatype

boolean

Alias
UMLS CUI [1]
C0182638
UMLS CUI [2]
C0038467
UMLS CUI [3]
C0036147
impaired cardiac function
Beschrijving

Decreased cardiac function

Datatype

boolean

Alias
UMLS CUI [1]
C0232166
heart disease
Beschrijving

Heart Disease

Datatype

boolean

Alias
UMLS CUI [1]
C0018799
liver or renal disease with impaired function
Beschrijving

Liver disease | Kidney Disease | Liver Dysfunction | Renal Insufficiency

Datatype

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0022658
UMLS CUI [3]
C0086565
UMLS CUI [4]
C1565489
other protocol-defined inclusion/exclusion criteria may apply
Beschrijving

Eligibility Criteria Study Protocol

Datatype

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Prostate Cancer NCT00667862

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of prostate
Item
confirmed diagnosis of adenocarcinoma of the prostate
boolean
C0007112 (UMLS CUI [1])
Hormone refractory prostate cancer metastatic
Item
patients with metastatic hormone refractory prostate cancer
boolean
C1328504 (UMLS CUI [1,1])
C1522484 (UMLS CUI [1,2])
Cytotoxic therapy Quantity Prostate carcinoma
Item
patients that have had at least one, but not more than two prior cytotoxic treatments for prostate cancer
boolean
C0677881 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0600139 (UMLS CUI [1,3])
Disease Progression | Criteria Quantity
Item
evidence of disease progression by at least one of the following
boolean
C0242656 (UMLS CUI [1])
C0243161 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Lesion Quantity Bone scan
Item
1. two or more lesions on bone scan
boolean
C0221198 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0203668 (UMLS CUI [1,3])
Measurable Disease Progressive
Item
2. progressive measurable disease
boolean
C1513041 (UMLS CUI [1,1])
C0205329 (UMLS CUI [1,2])
Raised prostate specific antigen Quantity
Item
3. two documented increases in psa
boolean
C0178415 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Contraceptive methods Willing
Item
willing to use contraception throughout the study and for 12 weeks after study completion
boolean
C0700589 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Sign or Symptom CNS disorder
Item
history or clinical signs of cns disease
boolean
C3540840 (UMLS CUI [1,1])
C0007682 (UMLS CUI [1,2])
Cancer Other Disease length | Curative treatment Absent
Item
history of other cancers not curatively treated with no evidence of disease for more than 5 years
boolean
C1707251 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C1273390 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Prior radiation therapy
Item
prior radiotherapy within 3 weeks of starting study treatment
boolean
C0279134 (UMLS CUI [1])
Radiopharmaceuticals | Strontium | Samarium
Item
prior radiopharmaceuticals (strontium, samarium)
boolean
C0182638 (UMLS CUI [1])
C0038467 (UMLS CUI [2])
C0036147 (UMLS CUI [3])
Decreased cardiac function
Item
impaired cardiac function
boolean
C0232166 (UMLS CUI [1])
Heart Disease
Item
heart disease
boolean
C0018799 (UMLS CUI [1])
Liver disease | Kidney Disease | Liver Dysfunction | Renal Insufficiency
Item
liver or renal disease with impaired function
boolean
C0023895 (UMLS CUI [1])
C0022658 (UMLS CUI [2])
C0086565 (UMLS CUI [3])
C1565489 (UMLS CUI [4])
Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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