Information:
Fel:
ID
14796
Beskrivning
Phase I, Dose Study to Look at the Safety and Pharmacokinetics of AZD8835 in Patients With Advanced Solid Tumours; ODM derived from: https://clinicaltrials.gov/show/NCT02260661
Länk
https://clinicaltrials.gov/show/NCT02260661
Nyckelord
Versioner (1)
- 2016-04-28 2016-04-28 -
Uppladdad den
28 april 2016
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Advanced Solid Malignancies NCT02260661
Eligibility Advanced Solid Malignancies NCT02260661
- StudyEvent: Eligibility
Similar models
Eligibility Advanced Solid Malignancies NCT02260661
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
informed consent
Item
understand the nature of the trial and provide signed and dated written consent
boolean
C0021430 (UMLS CUI [1])
solid tumor
Item
histological or cytological confirmation of a solid tumor and disease progression
boolean
C0280100 (UMLS CUI [1])
breast cancer
Item
histological or cytological confirmation of er+her2- negative breast cancer and disease progression or any other solid tumor with a pik3ca gene mutation
boolean
C0678222 (UMLS CUI [1,1])
C1335212 (UMLS CUI [1,2])
C1335212 (UMLS CUI [1,2])
postmenopausal
Item
histological or cytological confirmation of er+her2- negative postmenopausal breast cancer with locally advanced or metastatic disease that is eligible for fulvestrant treatment
boolean
C0232970 (UMLS CUI [1])
metastatic disease
Item
histological or cytological confirmation of er+her2- negative postmenopausal breast cancer with locally advanced or metastatic disease that is eligible for fulvestrant treatment. patients must also present with a tumor related mutation of the pik3ca gene.
boolean
C0936223 (UMLS CUI [1])
chemotherapy
Item
recent chemotherapy, radiotherapy, hormonal therapy, immunotherapy or investigational drugs within 21 days or 5 half-days from enrolment
boolean
C0392920 (UMLS CUI [1])
radiotherapy
Item
received palliative/focal radiotherapy within 2 weeks of first dose of study treatment
boolean
C1522449 (UMLS CUI [1])
major surgery
Item
major surgery less than or equal to 21 days from beginning of study drug
boolean
C0679637 (UMLS CUI [1])
ventricular arrhythmia, unstable angina
Item
any of the following cardiac criteria: chf > class ii, cardiac ventricular arrhythmia requiring therapy, unstable angina, qtcf interval >470ms, abnormal echo or muga at baseline (lvef <50%)
boolean
C0085612 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0002965 (UMLS CUI [2])