ID

15838

Beschreibung

Study of MOR209/ES414 in Metastatic Castration-Resistant Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02262910

Link

https://clinicaltrials.gov/show/NCT02262910

Stichworte

Versionen (1)
  1. 15.06.16 15.06.16 -
Hochgeladen am

15. Juni 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT02262910

Englisch

Eligibility Prostate Cancer NCT02262910

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed adenocarcinoma of the prostate. no evidence of neuroendocrine differentiation or small cell features.
Beschreibung

Adenocarcinoma of prostate | No evidence of Neuroendocrine Differentiation

Datentyp

boolean

Alias
UMLS CUI [1]
C0007112
UMLS CUI [2,1]
C0332125
UMLS CUI [2,2]
C1709218
surgically or medically castrated, with testosterone ≤ 50 ng/dl (≤ 1.7 nmol/l).
Beschreibung

Castration | Medical Castration | Testosterone measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0007344
UMLS CUI [2]
C1513054
UMLS CUI [3]
C0523912
progressive prostate cancer by either serum psa levels, soft tissue or bone disease as defined by the pcwg2 criteria.
Beschreibung

Prostate carcinoma Progressive | Prostate specific antigen measurement | Disorder of soft tissue | Bone Diseases

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0600139
UMLS CUI [1,2]
C0205329
UMLS CUI [2]
C0201544
UMLS CUI [3]
C0263978
UMLS CUI [4]
C0005940
in stage 1, patients may or may not have received prior chemotherapy for mcrpc. in stage 2, patients will be enrolled into two cohorts based on whether or not they have received prior chemotherapy for mcrpc. any prior chemotherapy must have been completed ≥ 4 weeks prior to administration of es414. additionally, in countries where abiraterone or enzalutamide are commercially available, patients in stage 1 and 2 must have progressed on abiraterone and/or enzalutamide prior to study entry.
Beschreibung

Prior Chemotherapy | Prostatic Cancer, Castration-Resistant Metastatic | abiraterone | enzalutamide

Datentyp

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2,1]
C3658266
UMLS CUI [2,2]
C0036525
UMLS CUI [3]
C0754011
UMLS CUI [4]
C3496793
ecog ≤ 1
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy > 6 months per investigator
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
adequate hematologic, renal, and hepatic parameters
Beschreibung

Hematologic function | Renal function | Liver function

Datentyp

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
any chemotherapy or investigational drug in prior 4 weeks
Beschreibung

Chemotherapy | Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0013230
any radiation therapy in prior 2 weeks
Beschreibung

Therapeutic radiology procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C1522449
any prior therapy targeted against psma
Beschreibung

Targeted Therapy Previous Against prostate-specific membrane antigen

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2985566
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0521124
UMLS CUI [1,4]
C1310550
history of seizures
Beschreibung

Seizures

Datentyp

boolean

Alias
UMLS CUI [1]
C0036572
history of central nervous system metastasis
Beschreibung

CNS metastases

Datentyp

boolean

Alias
UMLS CUI [1]
C0686377
history of nephrotic syndrome
Beschreibung

Nephrotic Syndrome

Datentyp

boolean

Alias
UMLS CUI [1]
C0027726
spot urine total protein:creatinine ratio >1,000 mg/gm
Beschreibung

Urine total protein measurement Spot urine sample | Creatinine measurement, serum | Ratio

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0428541
UMLS CUI [1,2]
C0457208
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0456603
planned palliative procedures for alleviation of bone pain
Beschreibung

Palliative procedure Planned | Bone pain

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1285158
UMLS CUI [1,2]
C1301732
UMLS CUI [2]
C0151825
active infection requiring treatment with systemic anti-infectives or major surgery in prior 4 weeks.
Beschreibung

Communicable Diseases | Therapeutic procedure Anti-Infective Agents Systemic | major surgery

Datentyp

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0003204
UMLS CUI [2,3]
C0205373
UMLS CUI [3]
C0679637
any prednisone (or equivalent corticosteroids) use within 4 weeks of study entry
Beschreibung

Prednisone | Adrenal Cortex Hormones equivalent

Datentyp

boolean

Alias
UMLS CUI [1]
C0032952
UMLS CUI [2,1]
C0001617
UMLS CUI [2,2]
C3242703
chronic immunosuppressive therapy
Beschreibung

Therapeutic immunosuppression chronic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021079
UMLS CUI [1,2]
C0205191
known history of hiv, hepatitis b, or hepatitis c infection
Beschreibung

HIV | Hepatitis B | Hepatitis C

Datentyp

boolean

Alias
UMLS CUI [1]
C0019682
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
evidence of severe or uncontrolled systemic diseases
Beschreibung

Systemic disease Severe | Systemic disease Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0442893
UMLS CUI [2,2]
C0205318
history of bleeding disorders or thromboembolic events in prior 3 months
Beschreibung

Blood Coagulation Disorders | Thromboembolism

Datentyp

boolean

Alias
UMLS CUI [1]
C0005779
UMLS CUI [2]
C0040038
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Ähnliche Modelle

Eligibility Prostate Cancer NCT02262910

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of prostate | No evidence of Neuroendocrine Differentiation
Item
histologically or cytologically confirmed adenocarcinoma of the prostate. no evidence of neuroendocrine differentiation or small cell features.
boolean
C0007112 (UMLS CUI [1])
C0332125 (UMLS CUI [2,1])
C1709218 (UMLS CUI [2,2])
Castration | Medical Castration | Testosterone measurement
Item
surgically or medically castrated, with testosterone ≤ 50 ng/dl (≤ 1.7 nmol/l).
boolean
C0007344 (UMLS CUI [1])
C1513054 (UMLS CUI [2])
C0523912 (UMLS CUI [3])
Prostate carcinoma Progressive | Prostate specific antigen measurement | Disorder of soft tissue | Bone Diseases
Item
progressive prostate cancer by either serum psa levels, soft tissue or bone disease as defined by the pcwg2 criteria.
boolean
C0600139 (UMLS CUI [1,1])
C0205329 (UMLS CUI [1,2])
C0201544 (UMLS CUI [2])
C0263978 (UMLS CUI [3])
C0005940 (UMLS CUI [4])
Prior Chemotherapy | Prostatic Cancer, Castration-Resistant Metastatic | abiraterone | enzalutamide
Item
in stage 1, patients may or may not have received prior chemotherapy for mcrpc. in stage 2, patients will be enrolled into two cohorts based on whether or not they have received prior chemotherapy for mcrpc. any prior chemotherapy must have been completed ≥ 4 weeks prior to administration of es414. additionally, in countries where abiraterone or enzalutamide are commercially available, patients in stage 1 and 2 must have progressed on abiraterone and/or enzalutamide prior to study entry.
boolean
C1514457 (UMLS CUI [1])
C3658266 (UMLS CUI [2,1])
C0036525 (UMLS CUI [2,2])
C0754011 (UMLS CUI [3])
C3496793 (UMLS CUI [4])
ECOG performance status
Item
ecog ≤ 1
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy > 6 months per investigator
boolean
C0023671 (UMLS CUI [1])
Hematologic function | Renal function | Liver function
Item
adequate hematologic, renal, and hepatic parameters
boolean
C0221130 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Chemotherapy | Investigational New Drugs
Item
any chemotherapy or investigational drug in prior 4 weeks
boolean
C0392920 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Therapeutic radiology procedure
Item
any radiation therapy in prior 2 weeks
boolean
C1522449 (UMLS CUI [1])
Targeted Therapy Previous Against prostate-specific membrane antigen
Item
any prior therapy targeted against psma
boolean
C2985566 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0521124 (UMLS CUI [1,3])
C1310550 (UMLS CUI [1,4])
Seizures
Item
history of seizures
boolean
C0036572 (UMLS CUI [1])
CNS metastases
Item
history of central nervous system metastasis
boolean
C0686377 (UMLS CUI [1])
Nephrotic Syndrome
Item
history of nephrotic syndrome
boolean
C0027726 (UMLS CUI [1])
Urine total protein measurement Spot urine sample | Creatinine measurement, serum | Ratio
Item
spot urine total protein:creatinine ratio >1,000 mg/gm
boolean
C0428541 (UMLS CUI [1,1])
C0457208 (UMLS CUI [1,2])
C0201976 (UMLS CUI [2])
C0456603 (UMLS CUI [3])
Palliative procedure Planned | Bone pain
Item
planned palliative procedures for alleviation of bone pain
boolean
C1285158 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0151825 (UMLS CUI [2])
Communicable Diseases | Therapeutic procedure Anti-Infective Agents Systemic | major surgery
Item
active infection requiring treatment with systemic anti-infectives or major surgery in prior 4 weeks.
boolean
C0009450 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0003204 (UMLS CUI [2,2])
C0205373 (UMLS CUI [2,3])
C0679637 (UMLS CUI [3])
Prednisone | Adrenal Cortex Hormones equivalent
Item
any prednisone (or equivalent corticosteroids) use within 4 weeks of study entry
boolean
C0032952 (UMLS CUI [1])
C0001617 (UMLS CUI [2,1])
C3242703 (UMLS CUI [2,2])
Therapeutic immunosuppression chronic
Item
chronic immunosuppressive therapy
boolean
C0021079 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
HIV | Hepatitis B | Hepatitis C
Item
known history of hiv, hepatitis b, or hepatitis c infection
boolean
C0019682 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
Systemic disease Severe | Systemic disease Uncontrolled
Item
evidence of severe or uncontrolled systemic diseases
boolean
C0442893 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0442893 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Blood Coagulation Disorders | Thromboembolism
Item
history of bleeding disorders or thromboembolic events in prior 3 months
boolean
C0005779 (UMLS CUI [1])
C0040038 (UMLS CUI [2])
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