ID

27380

Descrição

AMG 102 in Combination With Mitoxantrone and Prednisone in Subjects With Previously Treated Castrate Resistant Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00770848

Link

https://clinicaltrials.gov/show/NCT00770848

Palavras-chave

Versões (1)
  1. 10/11/2017 10/11/2017 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

10 de novembro de 2017

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Cancer NCT00770848

Inglês

Eligibility Cancer NCT00770848

1 Formulários  
  1. StudyEvent: Eligibility
    1. Eligibility Cancer NCT00770848
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
pathologically confirmed adenocarcinoma of the prostate
Descrição

Adenocarcinoma of prostate

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0007112
radiographic evidence of metastatic disease
Descrição

Neoplasm Metastasis Evidence of Radiography

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0332120
UMLS CUI [1,3]
C0034571
progressive disease meeting at least one of the following criteria:
Descrição

Progressive Disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1335499
1. a sequence of at least 2 rising psa values measured at a minimum of 1 week apart with a 2 ng/ml minimum starting value, or
Descrição

Raised prostate specific antigen Measurement Quantity

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0178415
UMLS CUI [1,2]
C0242485
UMLS CUI [1,3]
C1265611
2. progression according to recist criteria for measurable lesions, or
Descrição

Disease Progression | Measurable Disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2]
C1513041
3. appearance of 2 or more new lesions on bone scan.
Descrição

Lesion New Quantity Bone scan

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0205314
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0203668
history of prior taxane-based chemotherapy for metastatic prostate cancer
Descrição

Chemotherapy Secondary malignant neoplasm of prostate | taxane

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0347001
UMLS CUI [2]
C0215136
for patients without a history of surgical castration, continued gnrh analog administration is required
Descrição

Male Castration Absent | GnRH Analog Continued Patient need for

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0007347
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1518041
UMLS CUI [2,2]
C0549178
UMLS CUI [2,3]
C0686904
ecog performance status of 0 or 1
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy ≥ 3 months
Descrição

Life Expectancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
treatment with external beam radiotherapy ≤ 14 days before enrollment or radiopharmaceutical ≤8 weeks
Descrição

External Beam Radiation Therapy | Radiopharmaceuticals

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1517033
UMLS CUI [2]
C0182638
≤ 4 weeks since receipt of most recent prior chemotherapy, non-gnrh analog hormonal therapy (except for continuing corticosteroids) or other systemic therapy to treat prostate cancer and <6 weeks since receipt of prior bevacizumab.
Descrição

Prior Chemotherapy | Hormone Therapy Without GnRH Analog | Exception Adrenal Cortex Hormones | Systemic therapy Prostate carcinoma | bevacizumab

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2,1]
C0279025
UMLS CUI [2,2]
C0332288
UMLS CUI [2,3]
C1518041
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0001617
UMLS CUI [4,1]
C1515119
UMLS CUI [4,2]
C0600139
UMLS CUI [5]
C0796392
known cns metastases (epidural disease is allowed if it has been treated and there is no progression in the treated area).
Descrição

CNS metastases | Disease Epidural Treated allowed | Disease Progression Absent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0686377
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C1550254
UMLS CUI [2,3]
C1522326
UMLS CUI [2,4]
C0683607
UMLS CUI [3,1]
C0242656
UMLS CUI [3,2]
C0332197
significant cardiovascular disease
Descrição

Cardiovascular Diseases

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0007222
lvef < 50% by muga or echo
Descrição

Left ventricular ejection fraction Multiple gated acquisition scanning | Left ventricular ejection fraction Echocardiography

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0521317
UMLS CUI [2,1]
C0428772
UMLS CUI [2,2]
C0013516
treatment of infection with systemic anti-infectives within 7 days before enrollment (with the exception of uncomplicated urinary tract infection)
Descrição

ANTIINFECTIVES FOR SYSTEMIC USE Communicable Diseases | Exception URINARY TRACT INFECTION UNCOMPLICATED

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3653775
UMLS CUI [1,2]
C0009450
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0749974
concurrent or prior (within 7 days of enrollment) anticoagulation therapy, except that use of low dose coumarin-type anticoagulants or heparins for prophylaxis against central venous catheter thrombosis is allowed
Descrição

Anticoagulation Therapy | Exception Coumarin Low dose | Exception Heparin Low dose | Prophylaxis Thrombosis Central venous catheter Related

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0003281
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0010206
UMLS CUI [2,3]
C0445550
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0019134
UMLS CUI [3,3]
C0445550
UMLS CUI [4,1]
C0199176
UMLS CUI [4,2]
C0040053
UMLS CUI [4,3]
C1145640
UMLS CUI [4,4]
C0439849
major surgical procedure ≤30 days before enrollment or not yet recovered from prior major surgery
Descrição

Major surgery | Major surgery Recovery Lacking

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2,1]
C0679637
UMLS CUI [2,2]
C2004454
UMLS CUI [2,3]
C0332268
presence of peripheral edema > grade 2
Descrição

Peripheral edema Grade

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0085649
UMLS CUI [1,2]
C0441800
known positive test for hiv, hepatitis c, chronic or active hepatitis b
Descrição

HIV Seropositivity | Hepatitis C | Hepatitis B, Chronic | Hepatitis B

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0019196
UMLS CUI [3]
C0524909
UMLS CUI [4]
C0019163
serious or non-healing wound
Descrição

Wound Serious | Wound, non-healed

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0043250
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0750433
unable to begin protocol specified treatment within 7 days after enrollment
Descrição

Protocol Compliance Unable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
other investigational procedures are excluded.
Descrição

Procedures Investigational Other

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0184661
UMLS CUI [1,2]
C1517586
UMLS CUI [1,3]
C0205394
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Similar models

Eligibility Cancer NCT00770848

1 Formulários
  1. StudyEvent: Eligibility
    1. Eligibility Cancer NCT00770848
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of prostate
Item
pathologically confirmed adenocarcinoma of the prostate
boolean
C0007112 (UMLS CUI [1])
Neoplasm Metastasis Evidence of Radiography
Item
radiographic evidence of metastatic disease
boolean
C0027627 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0034571 (UMLS CUI [1,3])
Progressive Disease
Item
progressive disease meeting at least one of the following criteria:
boolean
C1335499 (UMLS CUI [1])
Raised prostate specific antigen Measurement Quantity
Item
1. a sequence of at least 2 rising psa values measured at a minimum of 1 week apart with a 2 ng/ml minimum starting value, or
boolean
C0178415 (UMLS CUI [1,1])
C0242485 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Disease Progression | Measurable Disease
Item
2. progression according to recist criteria for measurable lesions, or
boolean
C0242656 (UMLS CUI [1])
C1513041 (UMLS CUI [2])
Lesion New Quantity Bone scan
Item
3. appearance of 2 or more new lesions on bone scan.
boolean
C0221198 (UMLS CUI [1,1])
C0205314 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0203668 (UMLS CUI [1,4])
Chemotherapy Secondary malignant neoplasm of prostate | taxane
Item
history of prior taxane-based chemotherapy for metastatic prostate cancer
boolean
C0392920 (UMLS CUI [1,1])
C0347001 (UMLS CUI [1,2])
C0215136 (UMLS CUI [2])
Male Castration Absent | GnRH Analog Continued Patient need for
Item
for patients without a history of surgical castration, continued gnrh analog administration is required
boolean
C0007347 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1518041 (UMLS CUI [2,1])
C0549178 (UMLS CUI [2,2])
C0686904 (UMLS CUI [2,3])
ECOG performance status
Item
ecog performance status of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy ≥ 3 months
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
External Beam Radiation Therapy | Radiopharmaceuticals
Item
treatment with external beam radiotherapy ≤ 14 days before enrollment or radiopharmaceutical ≤8 weeks
boolean
C1517033 (UMLS CUI [1])
C0182638 (UMLS CUI [2])
Prior Chemotherapy | Hormone Therapy Without GnRH Analog | Exception Adrenal Cortex Hormones | Systemic therapy Prostate carcinoma | bevacizumab
Item
≤ 4 weeks since receipt of most recent prior chemotherapy, non-gnrh analog hormonal therapy (except for continuing corticosteroids) or other systemic therapy to treat prostate cancer and <6 weeks since receipt of prior bevacizumab.
boolean
C1514457 (UMLS CUI [1])
C0279025 (UMLS CUI [2,1])
C0332288 (UMLS CUI [2,2])
C1518041 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0001617 (UMLS CUI [3,2])
C1515119 (UMLS CUI [4,1])
C0600139 (UMLS CUI [4,2])
C0796392 (UMLS CUI [5])
CNS metastases | Disease Epidural Treated allowed | Disease Progression Absent
Item
known cns metastases (epidural disease is allowed if it has been treated and there is no progression in the treated area).
boolean
C0686377 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C1550254 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C0683607 (UMLS CUI [2,4])
C0242656 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Cardiovascular Diseases
Item
significant cardiovascular disease
boolean
C0007222 (UMLS CUI [1])
Left ventricular ejection fraction Multiple gated acquisition scanning | Left ventricular ejection fraction Echocardiography
Item
lvef < 50% by muga or echo
boolean
C0428772 (UMLS CUI [1,1])
C0521317 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2,1])
C0013516 (UMLS CUI [2,2])
ANTIINFECTIVES FOR SYSTEMIC USE Communicable Diseases | Exception URINARY TRACT INFECTION UNCOMPLICATED
Item
treatment of infection with systemic anti-infectives within 7 days before enrollment (with the exception of uncomplicated urinary tract infection)
boolean
C3653775 (UMLS CUI [1,1])
C0009450 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0749974 (UMLS CUI [2,2])
Anticoagulation Therapy | Exception Coumarin Low dose | Exception Heparin Low dose | Prophylaxis Thrombosis Central venous catheter Related
Item
concurrent or prior (within 7 days of enrollment) anticoagulation therapy, except that use of low dose coumarin-type anticoagulants or heparins for prophylaxis against central venous catheter thrombosis is allowed
boolean
C0003281 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0010206 (UMLS CUI [2,2])
C0445550 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0019134 (UMLS CUI [3,2])
C0445550 (UMLS CUI [3,3])
C0199176 (UMLS CUI [4,1])
C0040053 (UMLS CUI [4,2])
C1145640 (UMLS CUI [4,3])
C0439849 (UMLS CUI [4,4])
Major surgery | Major surgery Recovery Lacking
Item
major surgical procedure ≤30 days before enrollment or not yet recovered from prior major surgery
boolean
C0679637 (UMLS CUI [1])
C0679637 (UMLS CUI [2,1])
C2004454 (UMLS CUI [2,2])
C0332268 (UMLS CUI [2,3])
Peripheral edema Grade
Item
presence of peripheral edema > grade 2
boolean
C0085649 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
HIV Seropositivity | Hepatitis C | Hepatitis B, Chronic | Hepatitis B
Item
known positive test for hiv, hepatitis c, chronic or active hepatitis b
boolean
C0019699 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
C0524909 (UMLS CUI [3])
C0019163 (UMLS CUI [4])
Wound Serious | Wound, non-healed
Item
serious or non-healing wound
boolean
C0043250 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0750433 (UMLS CUI [2])
Protocol Compliance Unable
Item
unable to begin protocol specified treatment within 7 days after enrollment
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Procedures Investigational Other
Item
other investigational procedures are excluded.
boolean
C0184661 (UMLS CUI [1,1])
C1517586 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
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