Informações:
Falhas:
ID
22665
Descrição
Study of XL647 in Subjects With NSCLC Who Have Progressed After Responding to Treatment With Gefitinib or Erlotinib; ODM derived from: https://clinicaltrials.gov/show/NCT00522145
Link
https://clinicaltrials.gov/show/NCT00522145
Palavras-chave
Versões (1)
- 09/06/2017 09/06/2017 -
Transferido a
9 de junho de 2017
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Carcinoma, Non-Small-Cell Lung NCT00522145
Eligibility Carcinoma, Non-Small-Cell Lung NCT00522145
- StudyEvent: Eligibility
Similar models
Eligibility Carcinoma, Non-Small-Cell Lung NCT00522145
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
ID.1
Item
histologically confirmed diagnosis of unresectable stage iiib or stage iv relapsed or recurrent nsclc.
boolean
C0007131 (UMLS CUI [1,1])
C1519810 (UMLS CUI [1,2])
C1519810 (UMLS CUI [1,2])
ID.2
Item
subjects must have:
boolean
ID.3
Item
1. documented (radiological or clinical) progressive disease (pd) following a prior response (including stable disease) to monotherapy with erlotinib or gefitinib that was administered for at least 12 weeks prior to progression or
boolean
C0677932 (UMLS CUI [1,1])
C1135135 (UMLS CUI [1,2])
C1122962 (UMLS CUI [1,3])
C1135135 (UMLS CUI [1,2])
C1122962 (UMLS CUI [1,3])
ID.4
Item
2. a documented t790m egfr mutation
boolean
C3708475 (UMLS CUI [1])
ID.5
Item
measurable disease defined according to recist
boolean
C1709926 (UMLS CUI [1])
ID.6
Item
ecog performance status of 0 or 1.
boolean
C1520224 (UMLS CUI [1])
ID.7
Item
sexually active subjects must use an accepted method of contraception during the course of the study.
boolean
C0009862 (UMLS CUI [1])
ID.8
Item
female subjects of childbearing potential must have a negative pregnancy test at enrollment.
boolean
C0427780 (UMLS CUI [1])
ID.9
Item
received radiation to ≥25% of his or her bone marrow within 30 days of xl647 treatment.
boolean
C1522449 (UMLS CUI [1])
ID.10
Item
received erlotinib or gefitinib, or other anticancer therapy within 14 days of the first dose of study drug.
boolean
C0920425 (UMLS CUI [1])
ID.11
Item
received an investigational drug (excluding erlotinib or gefitinib) within 30 days of the first dose of study drug.
boolean
C0162778 (UMLS CUI [1])
ID.12
Item
receiving anticoagulation therapy with warfarin.
boolean
C0043031 (UMLS CUI [1])
ID.13
Item
not recovered to grade ≤1 from adverse events (aes) due to antineoplastic agents, investigational drugs, or other medications that were administered prior to study enrollment.
boolean
C1705586 (UMLS CUI [1])
ID.14
Item
corrected qt interval (qtc) of >0.45 seconds.
boolean
C0855333 (UMLS CUI [1])
ID.15
Item
progressive, symptomatic, or hemorrhagic brain or leptomeningeal metastases.
boolean
C0027627 (UMLS CUI [1,1])
C0220650 (UMLS CUI [1,2])
C1704231 (UMLS CUI [1,3])
C0220650 (UMLS CUI [1,2])
C1704231 (UMLS CUI [1,3])
ID.16
Item
requires steroid or anticonvulsant therapy for the treatment of brain metastases.
boolean