ID

30605

Beskrivning

Study of Denosumab in the Treatment of Hypercalcemia of Malignancy in Subjects With Elevated Serum Calcium; ODM derived from: https://clinicaltrials.gov/show/NCT00896454

Länk

https://clinicaltrials.gov/show/NCT00896454

Nyckelord

Versioner (1)
  1. 2018-06-17 2018-06-17 -
Rättsinnehavare

see clinicaltrials.gov

Uppladdad den

17 juni 2018

DOI

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Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00896454

Engelsk

Eligibility Breast Cancer NCT00896454

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
hypercalcemia of malignancy (hcm) as defined as documented histologically or cytologically confirmed cancer and a corrected serum calcium (csc) > 12.5 mg/dl (3.1 millimoles /l) at screening by local laboratory
Beskrivning

hypercalcemia of malignancy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020437
UMLS CUI [1,2]
C0006826
last iv bisphosphonate treatment must be >/= to 7 days and </= to 30 days before the screening corrected serum calcium
Beskrivning

Diphosphonates, intravenous administration, Before Screening procedure; Corrected serum calcium measurement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012544
UMLS CUI [1,2]
C0013125
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C0220908
UMLS CUI [2]
C0455288
adults (>/=18 years)
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
adequate organ function as defined by the following criteria:
Beskrivning

body system or organ function

Datatyp

boolean

Alias
UMLS CUI [1]
C0678852
serum aspartate aminotransferase (ast) </= 5 x upper limit of normal (uln)
Beskrivning

Aspartate aminotransferase measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0201899
serum alanine aminotransferase (alt) </= 5 x upper limit of normal
Beskrivning

Alanine aminotransferase measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0201836
serum total bilirubin </= 2 x upper limit of normal
Beskrivning

Serum total bilirubin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C1278039
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
evidence of benign hyperparathyroidism, hyperthyroidism, adrenal insufficiency, vitamin d intoxication, milk alkali syndrome, sarcoidosis, or other granulomatous disease
Beskrivning

Hyperparathyroidism, Benign; Hyperthyroidism; Adrenal gland hypofunction; Poisoning by vitamin D; Milk-Alkali Syndrome; Sarcoidosis; Granulomatous disorder, Other

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020502
UMLS CUI [1,2]
C0205183
UMLS CUI [2]
C0020550
UMLS CUI [3]
C0001623
UMLS CUI [4]
C0242154
UMLS CUI [5]
C0026141
UMLS CUI [6]
C0036202
UMLS CUI [7,1]
C0740451
UMLS CUI [7,2]
C0205394
receiving dialysis for renal failure
Beskrivning

Kidney Failure, Dialysis procedure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0035078
UMLS CUI [1,2]
C0011946
treatment with thiazides, calcitonin, mithramycin, or gallium nitrate within their window of expected therapeutic effect (as determined by the physician) prior to the date of the screening csc
Beskrivning

Thiazide Diuretics Therapeutic procedure, Therapeutic Effect, Before Screening procedure; Calcitonin Therapeutic procedure, Therapeutic Effect, Before Screening procedure; Plicamycin Therapeutic procedure, Therapeutic Effect, Before Screening procedure; gallium nitrate Therapeutic procedure, Therapeutic Effect, Before Screening procedure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012802
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C1527144
UMLS CUI [1,4]
C0332152
UMLS CUI [1,5]
C0220908
UMLS CUI [2,1]
C0006668
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C1527144
UMLS CUI [2,4]
C0332152
UMLS CUI [2,5]
C0220908
UMLS CUI [3,1]
C0026234
UMLS CUI [3,2]
C0087111
UMLS CUI [3,3]
C1527144
UMLS CUI [3,4]
C0332152
UMLS CUI [3,5]
C0220908
UMLS CUI [4,1]
C0061008
UMLS CUI [4,2]
C0087111
UMLS CUI [4,3]
C1527144
UMLS CUI [4,4]
C0332152
UMLS CUI [4,5]
C0220908
treatment with cinacalcet within 4 weeks prior to the date of the screening csc
Beskrivning

cinacalcet Therapeutic procedure Before Screening procedure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1337242
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C0220908
thirty days or less since receiving an investigational product (other than denosumab) or device (ie, does not have marketing authorization; thalidomide use is allowed) in another clinical study
Beskrivning

Study Subject Participation Status, Investigational New Drugs, Previous; Study Subject Participation Status, Investigational Medical Device, Previous

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0205156
UMLS CUI [2,1]
C2348568
UMLS CUI [2,2]
C2346570
UMLS CUI [2,3]
C0205156
known sensitivity to any of the products to be administered during the study (eg, mammalian derived products)
Beskrivning

Hypersensitivity, clinical trial drug

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C3854006
female subject is pregnant or breast feeding, or planning to become pregnant within 7 months after the end of treatment
Beskrivning

Pregnancy; Breastfeeding; Pregnancy, Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
female subject of childbearing potential is not willing to use 2 highly effective methods of contraception during treatment and for 7 months after the end of treatment
Beskrivning

Contraceptive methods, Unwilling

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0558080
subject will not be available for follow-up assessment.
Beskrivning

Clinical Study Follow-up, Availability of, Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C0470187
UMLS CUI [1,3]
C1299582
any organic or psychiatric disorder that, in the opinion of the investigator, might prevent the subject from completing the study or interfere with the interpretation of the study results
Beskrivning

Illness, Interferes withClinical Trials; Mental disorders, Interferes with Clinical Trials

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0008976
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0008976
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Similar models

Eligibility Breast Cancer NCT00896454

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
hypercalcemia of malignancy
Item
hypercalcemia of malignancy (hcm) as defined as documented histologically or cytologically confirmed cancer and a corrected serum calcium (csc) > 12.5 mg/dl (3.1 millimoles /l) at screening by local laboratory
boolean
C0020437 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
Diphosphonates, intravenous administration, Before Screening procedure; Corrected serum calcium measurement
Item
last iv bisphosphonate treatment must be >/= to 7 days and </= to 30 days before the screening corrected serum calcium
boolean
C0012544 (UMLS CUI [1,1])
C0013125 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0220908 (UMLS CUI [1,4])
C0455288 (UMLS CUI [2])
Age
Item
adults (>/=18 years)
boolean
C0001779 (UMLS CUI [1])
body system or organ function
Item
adequate organ function as defined by the following criteria:
boolean
C0678852 (UMLS CUI [1])
Aspartate aminotransferase measurement
Item
serum aspartate aminotransferase (ast) </= 5 x upper limit of normal (uln)
boolean
C0201899 (UMLS CUI [1])
Alanine aminotransferase measurement
Item
serum alanine aminotransferase (alt) </= 5 x upper limit of normal
boolean
C0201836 (UMLS CUI [1])
Serum total bilirubin measurement
Item
serum total bilirubin </= 2 x upper limit of normal
boolean
C1278039 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hyperparathyroidism, Benign; Hyperthyroidism; Adrenal gland hypofunction; Poisoning by vitamin D; Milk-Alkali Syndrome; Sarcoidosis; Granulomatous disorder, Other
Item
evidence of benign hyperparathyroidism, hyperthyroidism, adrenal insufficiency, vitamin d intoxication, milk alkali syndrome, sarcoidosis, or other granulomatous disease
boolean
C0020502 (UMLS CUI [1,1])
C0205183 (UMLS CUI [1,2])
C0020550 (UMLS CUI [2])
C0001623 (UMLS CUI [3])
C0242154 (UMLS CUI [4])
C0026141 (UMLS CUI [5])
C0036202 (UMLS CUI [6])
C0740451 (UMLS CUI [7,1])
C0205394 (UMLS CUI [7,2])
Kidney Failure, Dialysis procedure
Item
receiving dialysis for renal failure
boolean
C0035078 (UMLS CUI [1,1])
C0011946 (UMLS CUI [1,2])
Thiazide Diuretics Therapeutic procedure, Therapeutic Effect, Before Screening procedure; Calcitonin Therapeutic procedure, Therapeutic Effect, Before Screening procedure; Plicamycin Therapeutic procedure, Therapeutic Effect, Before Screening procedure; gallium nitrate Therapeutic procedure, Therapeutic Effect, Before Screening procedure
Item
treatment with thiazides, calcitonin, mithramycin, or gallium nitrate within their window of expected therapeutic effect (as determined by the physician) prior to the date of the screening csc
boolean
C0012802 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C1527144 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
C0220908 (UMLS CUI [1,5])
C0006668 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C1527144 (UMLS CUI [2,3])
C0332152 (UMLS CUI [2,4])
C0220908 (UMLS CUI [2,5])
C0026234 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C1527144 (UMLS CUI [3,3])
C0332152 (UMLS CUI [3,4])
C0220908 (UMLS CUI [3,5])
C0061008 (UMLS CUI [4,1])
C0087111 (UMLS CUI [4,2])
C1527144 (UMLS CUI [4,3])
C0332152 (UMLS CUI [4,4])
C0220908 (UMLS CUI [4,5])
cinacalcet Therapeutic procedure Before Screening procedure
Item
treatment with cinacalcet within 4 weeks prior to the date of the screening csc
boolean
C1337242 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0220908 (UMLS CUI [1,4])
Study Subject Participation Status, Investigational New Drugs, Previous; Study Subject Participation Status, Investigational Medical Device, Previous
Item
thirty days or less since receiving an investigational product (other than denosumab) or device (ie, does not have marketing authorization; thalidomide use is allowed) in another clinical study
boolean
C2348568 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
C2348568 (UMLS CUI [2,1])
C2346570 (UMLS CUI [2,2])
C0205156 (UMLS CUI [2,3])
Hypersensitivity, clinical trial drug
Item
known sensitivity to any of the products to be administered during the study (eg, mammalian derived products)
boolean
C0020517 (UMLS CUI [1,1])
C3854006 (UMLS CUI [1,2])
Pregnancy; Breastfeeding; Pregnancy, Planned
Item
female subject is pregnant or breast feeding, or planning to become pregnant within 7 months after the end of treatment
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Contraceptive methods, Unwilling
Item
female subject of childbearing potential is not willing to use 2 highly effective methods of contraception during treatment and for 7 months after the end of treatment
boolean
C0700589 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
Clinical Study Follow-up, Availability of, Unable
Item
subject will not be available for follow-up assessment.
boolean
C3274571 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Illness, Interferes withClinical Trials; Mental disorders, Interferes with Clinical Trials
Item
any organic or psychiatric disorder that, in the opinion of the investigator, might prevent the subject from completing the study or interfere with the interpretation of the study results
boolean
C0221423 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0004936 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0008976 (UMLS CUI [2,3])
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