ID

14958

Beskrivning

AZD8186 First Time In Patient Ascending Dose Study; ODM derived from: https://clinicaltrials.gov/show/NCT01884285

Länk

https://clinicaltrials.gov/show/NCT01884285

Nyckelord

  1. 2016-05-09 2016-05-09 -
Uppladdad den

9 maj 2016

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Advanced Castrate-resistant Prostate Cancer (CRPC); NCT01884285

Eligibility Advanced Castrate-resistant Prostate Cancer (CRPC); NCT01884285

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
provision of signed and dated, written informed consent prior to any study specific procedures
Beskrivning

informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
male or female, aged 18 years and older
Beskrivning

age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
histologically or cytologically proven diagnosis of prostate cancer, squamous non small cell lung cancer (sqnsclc), triple negative breast cancer (tnbc), or a known pten-deficient solid malignancy, that is refractory to standard therapies
Beskrivning

prostate cancer, squamous non small cell lung cancer

Datatyp

boolean

Alias
UMLS CUI [1]
C0600139
UMLS CUI [2]
C0007131
females should be using adequate contraceptive measures (see section 4.3), should not be breast feeding and must have a negative pregnancy test prior to start of dosing if of child-bearing potential
Beskrivning

Contraceptive measures

Datatyp

boolean

Alias
UMLS CUI [1]
C0700589
world health organisation (who)/ecog performance status 0 to 1 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks
Beskrivning

ecog performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
treatment before study with (a) nitrosourea or mitomycin c; (b) investigational agents from a previous clinical study; (c) chemotherapy, immunotherapy or anticancer agents; (d) hormonal therapy (e.g., steroids)
Beskrivning

nitrosourea

Datatyp

boolean

Alias
UMLS CUI [1]
C0028210
UMLS CUI [2]
C0279025
treatment before study with (a) strong inhibitors and strong or moderate inducers of cyp3a4 (b) radiotherapy with a wide field of radiation
Beskrivning

strong inhibitors and strong or moderate inducers of cyp3a4

Datatyp

boolean

Alias
UMLS CUI [1]
C1142644
UMLS CUI [2]
C0034619
with the exception of alopecia or toxicities related to the use of gonadotropin-releasing hormone agonists any unresolved toxicities from prior therapy greater than common terminology criteria for adverse events grade 1 at the time of study treatment
Beskrivning

alopecia

Datatyp

boolean

Alias
UMLS CUI [1]
C0002170
spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring steroids
Beskrivning

spinal cord compression or brain metastases

Datatyp

boolean

Alias
UMLS CUI [1]
C0037926
UMLS CUI [2]
C0220650
any evidence of severe or uncontrolled systemic diseases including active liver disease (other than malignancy), active bleeding diatheses, or active infection including hepatitis b, hepatitis c and human immunodeficiency virus (hiv).
Beskrivning

systemic disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0442893

Similar models

Eligibility Advanced Castrate-resistant Prostate Cancer (CRPC); NCT01884285

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
informed consent
Item
provision of signed and dated, written informed consent prior to any study specific procedures
boolean
C0021430 (UMLS CUI [1])
age
Item
male or female, aged 18 years and older
boolean
C0001779 (UMLS CUI [1])
prostate cancer, squamous non small cell lung cancer
Item
histologically or cytologically proven diagnosis of prostate cancer, squamous non small cell lung cancer (sqnsclc), triple negative breast cancer (tnbc), or a known pten-deficient solid malignancy, that is refractory to standard therapies
boolean
C0600139 (UMLS CUI [1])
C0007131 (UMLS CUI [2])
Contraceptive measures
Item
females should be using adequate contraceptive measures (see section 4.3), should not be breast feeding and must have a negative pregnancy test prior to start of dosing if of child-bearing potential
boolean
C0700589 (UMLS CUI [1])
ecog performance status
Item
world health organisation (who)/ecog performance status 0 to 1 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
nitrosourea
Item
treatment before study with (a) nitrosourea or mitomycin c; (b) investigational agents from a previous clinical study; (c) chemotherapy, immunotherapy or anticancer agents; (d) hormonal therapy (e.g., steroids)
boolean
C0028210 (UMLS CUI [1])
C0279025 (UMLS CUI [2])
strong inhibitors and strong or moderate inducers of cyp3a4
Item
treatment before study with (a) strong inhibitors and strong or moderate inducers of cyp3a4 (b) radiotherapy with a wide field of radiation
boolean
C1142644 (UMLS CUI [1])
C0034619 (UMLS CUI [2])
alopecia
Item
with the exception of alopecia or toxicities related to the use of gonadotropin-releasing hormone agonists any unresolved toxicities from prior therapy greater than common terminology criteria for adverse events grade 1 at the time of study treatment
boolean
C0002170 (UMLS CUI [1])
spinal cord compression or brain metastases
Item
spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring steroids
boolean
C0037926 (UMLS CUI [1])
C0220650 (UMLS CUI [2])
systemic disease
Item
any evidence of severe or uncontrolled systemic diseases including active liver disease (other than malignancy), active bleeding diatheses, or active infection including hepatitis b, hepatitis c and human immunodeficiency virus (hiv).
boolean
C0442893 (UMLS CUI [1])

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