ID

27380

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00770848

Nyckelord

Versioner (1)
  1. 2017-11-10 2017-11-10 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

10 november 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Cancer NCT00770848

Engelsk

Eligibility Cancer NCT00770848

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Cancer NCT00770848
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
pathologically confirmed adenocarcinoma of the prostate
Beskrivning

Adenocarcinoma of prostate

Datatyp

boolean

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

Neoplasm Metastasis Evidence of Radiography

Datatyp

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:
Beskrivning

Progressive Disease

Datatyp

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
Beskrivning

Raised prostate specific antigen Measurement Quantity

Datatyp

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
Beskrivning

Disease Progression | Measurable Disease

Datatyp

boolean

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

Lesion New Quantity Bone scan

Datatyp

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
Beskrivning

Chemotherapy Secondary malignant neoplasm of prostate | taxane

Datatyp

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
Beskrivning

Male Castration Absent | GnRH Analog Continued Patient need for

Datatyp

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
Beskrivning

ECOG performance status

Datatyp

boolean

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

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Beskrivning

Exclusion Criteria

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

External Beam Radiation Therapy | Radiopharmaceuticals

Datatyp

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.
Beskrivning

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

Datatyp

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).
Beskrivning

CNS metastases | Disease Epidural Treated allowed | Disease Progression Absent

Datatyp

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
Beskrivning

Cardiovascular Diseases

Datatyp

boolean

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

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

Datatyp

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)
Beskrivning

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

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

Major surgery | Major surgery Recovery Lacking

Datatyp

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
Beskrivning

Peripheral edema Grade

Datatyp

boolean

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

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

Datatyp

boolean

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

Wound Serious | Wound, non-healed

Datatyp

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
Beskrivning

Protocol Compliance Unable

Datatyp

boolean

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

Procedures Investigational Other

Datatyp

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 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Cancer NCT00770848
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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