ID

31640

Beschreibung

A Study of the Safety and Efficacy of Single-agent Carlumab (an Anti-Chemokine Ligand 2 [CCL2]) in Participants With Metastatic Castrate-Resistant Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00992186

Link

https://clinicaltrials.gov/show/NCT00992186

Stichworte

Versionen (1)
  1. 15.09.18 15.09.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

15. September 2018

DOI

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Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00992186

Englisch

Eligibility Prostate Cancer NCT00992186

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
histological documentation of adenocarcinoma of the prostate
Beschreibung

Adenocarcinoma of prostate

Datentyp

boolean

Alias
UMLS CUI [1]
C0007112
received at least 1 but no more than 2 prior docetaxel-based chemotherapy regimens and had disease progression following the last therapy
Beschreibung

Docetaxel Prior Chemotherapy Quantity | Disease Progression Post Therapeutic procedure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0246415
UMLS CUI [1,2]
C1514457
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0242656
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C0087111
serum prostate specific antigen (psa) greater than or equal to 5.0 nanogram/milliliter (ng/ml) within 4 weeks prior to the first dose of study agent
Beschreibung

Prostate specific antigen measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0201544
orchiectomy (surgery to remove one or both testicles) or testosterone less than 50 nanogram/deciliter by means of pharmacological/chemical castration within 4 weeks prior to the first dose of study agent
Beschreibung

Orchiectomy | Testosterone measurement | Medical Castration | Chemical male castration

Datentyp

boolean

Alias
UMLS CUI [1]
C0029189
UMLS CUI [2]
C0523912
UMLS CUI [3]
C1513054
UMLS CUI [4]
C0455189
at least 6 weeks from prior docetaxel chemotherapy regimen to first dose of study agent
Beschreibung

Docetaxel Prior Chemotherapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0246415
UMLS CUI [1,2]
C1514457
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
experience a hormonal treatment withdrawal response (including a lowering of psa that was previously rising or symptomatic improvement)
Beschreibung

Hormone Therapy Withdrawal Response | Prostatic specific antigen decreased | Raised prostate specific antigen Previous | Improvement Symptomatic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C2349954
UMLS CUI [1,3]
C1704632
UMLS CUI [2]
C0178414
UMLS CUI [3,1]
C0178415
UMLS CUI [3,2]
C0205156
UMLS CUI [4,1]
C2986411
UMLS CUI [4,2]
C0231220
known or symptomatic central nervous system metastases
Beschreibung

CNS metastases | CNS metastases Symptomatic

Datentyp

boolean

Alias
UMLS CUI [1]
C0686377
UMLS CUI [2,1]
C0686377
UMLS CUI [2,2]
C0231220
residual toxicities resulting from previous therapy that are grade 2 or more (except for alopecia)
Beschreibung

Toxicity Due to Prior Therapy CTCAE Grades | Exception Relationship Alopecia

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C1514463
UMLS CUI [1,4]
C1516728
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0439849
UMLS CUI [2,3]
C0002170
known allergies, hypersensitivity, or intolerance to carlumab or its excipients or clinically significant reactions to chimeric or human proteins
Beschreibung

Hypersensitivity Carlumab | Intolerance to Carlumab | Hypersensitivity Carlumab Excipient | Intolerance to Carlumab Excipient | Reaction Clinical Significance Fusion protein | Reaction Clinical Significance Proteins Human

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2346793
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C2346793
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C2346793
UMLS CUI [3,3]
C0015237
UMLS CUI [4,1]
C1744706
UMLS CUI [4,2]
C2346793
UMLS CUI [4,3]
C0015237
UMLS CUI [5,1]
C0443286
UMLS CUI [5,2]
C2826293
UMLS CUI [5,3]
C0162768
UMLS CUI [6,1]
C0443286
UMLS CUI [6,2]
C2826293
UMLS CUI [6,3]
C0033684
UMLS CUI [6,4]
C0086418
vaccinated with live, attenuated vaccines within 4 weeks prior to the first dose of study agent
Beschreibung

Vaccines, Attenuated

Datentyp

boolean

Alias
UMLS CUI [1]
C0042211
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Ähnliche Modelle

Eligibility Prostate Cancer NCT00992186

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of prostate
Item
histological documentation of adenocarcinoma of the prostate
boolean
C0007112 (UMLS CUI [1])
Docetaxel Prior Chemotherapy Quantity | Disease Progression Post Therapeutic procedure
Item
received at least 1 but no more than 2 prior docetaxel-based chemotherapy regimens and had disease progression following the last therapy
boolean
C0246415 (UMLS CUI [1,1])
C1514457 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0242656 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
Prostate specific antigen measurement
Item
serum prostate specific antigen (psa) greater than or equal to 5.0 nanogram/milliliter (ng/ml) within 4 weeks prior to the first dose of study agent
boolean
C0201544 (UMLS CUI [1])
Orchiectomy | Testosterone measurement | Medical Castration | Chemical male castration
Item
orchiectomy (surgery to remove one or both testicles) or testosterone less than 50 nanogram/deciliter by means of pharmacological/chemical castration within 4 weeks prior to the first dose of study agent
boolean
C0029189 (UMLS CUI [1])
C0523912 (UMLS CUI [2])
C1513054 (UMLS CUI [3])
C0455189 (UMLS CUI [4])
Docetaxel Prior Chemotherapy
Item
at least 6 weeks from prior docetaxel chemotherapy regimen to first dose of study agent
boolean
C0246415 (UMLS CUI [1,1])
C1514457 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Hormone Therapy Withdrawal Response | Prostatic specific antigen decreased | Raised prostate specific antigen Previous | Improvement Symptomatic
Item
experience a hormonal treatment withdrawal response (including a lowering of psa that was previously rising or symptomatic improvement)
boolean
C0279025 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
C1704632 (UMLS CUI [1,3])
C0178414 (UMLS CUI [2])
C0178415 (UMLS CUI [3,1])
C0205156 (UMLS CUI [3,2])
C2986411 (UMLS CUI [4,1])
C0231220 (UMLS CUI [4,2])
CNS metastases | CNS metastases Symptomatic
Item
known or symptomatic central nervous system metastases
boolean
C0686377 (UMLS CUI [1])
C0686377 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
Toxicity Due to Prior Therapy CTCAE Grades | Exception Relationship Alopecia
Item
residual toxicities resulting from previous therapy that are grade 2 or more (except for alopecia)
boolean
C0600688 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C1514463 (UMLS CUI [1,3])
C1516728 (UMLS CUI [1,4])
C1705847 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C0002170 (UMLS CUI [2,3])
Hypersensitivity Carlumab | Intolerance to Carlumab | Hypersensitivity Carlumab Excipient | Intolerance to Carlumab Excipient | Reaction Clinical Significance Fusion protein | Reaction Clinical Significance Proteins Human
Item
known allergies, hypersensitivity, or intolerance to carlumab or its excipients or clinically significant reactions to chimeric or human proteins
boolean
C0020517 (UMLS CUI [1,1])
C2346793 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C2346793 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C2346793 (UMLS CUI [3,2])
C0015237 (UMLS CUI [3,3])
C1744706 (UMLS CUI [4,1])
C2346793 (UMLS CUI [4,2])
C0015237 (UMLS CUI [4,3])
C0443286 (UMLS CUI [5,1])
C2826293 (UMLS CUI [5,2])
C0162768 (UMLS CUI [5,3])
C0443286 (UMLS CUI [6,1])
C2826293 (UMLS CUI [6,2])
C0033684 (UMLS CUI [6,3])
C0086418 (UMLS CUI [6,4])
Vaccines, Attenuated
Item
vaccinated with live, attenuated vaccines within 4 weeks prior to the first dose of study agent
boolean
C0042211 (UMLS CUI [1])
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