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ID
14958
Beschrijving
AZD8186 First Time In Patient Ascending Dose Study; ODM derived from: https://clinicaltrials.gov/show/NCT01884285
Link
https://clinicaltrials.gov/show/NCT01884285
Trefwoorden
Versies (1)
- 09-05-16 09-05-16 -
Geüploaded op
9 mei 2016
DOI
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Licentie
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
- StudyEvent: Eligibility
Similar models
Eligibility Advanced Castrate-resistant Prostate Cancer (CRPC); NCT01884285
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
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])
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])
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])
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])
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])
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])