ID

31571

Description

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

Keywords

Versions (1)
  1. 9/5/18 9/5/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 5, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00667862

English

Eligibility Prostate Cancer NCT00667862

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Adenocarcinoma of prostate

Data type

boolean

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

Hormone refractory prostate cancer metastatic

Data type

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
Description

Cytotoxic therapy Quantity Prostate carcinoma

Data type

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
Description

Disease Progression | Criteria Quantity

Data type

boolean

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

Lesion Quantity Bone scan

Data type

boolean

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

Measurable Disease Progressive

Data type

boolean

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

Raised prostate specific antigen Quantity

Data type

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
Description

Contraceptive methods Willing

Data type

boolean

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

Exclusion Criteria

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

Sign or Symptom CNS disorder

Data type

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
Description

Cancer Other Disease length | Curative treatment Absent

Data type

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
Description

Prior radiation therapy

Data type

boolean

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

Radiopharmaceuticals | Strontium | Samarium

Data type

boolean

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

Decreased cardiac function

Data type

boolean

Alias
UMLS CUI [1]
C0232166
heart disease
Description

Heart Disease

Data type

boolean

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

Liver disease | Kidney Disease | Liver Dysfunction | Renal Insufficiency

Data type

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
Description

Eligibility Criteria Study Protocol

Data type

boolean

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

Eligibility Prostate Cancer NCT00667862

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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