ID

34429

Description

LDK378 in Adult Chinese Patients With ALK-rearranged (ALK-positive) Advanced Non-small Cell Lung Cancer (NSCLC) Previously Treated With Crizotinib; ODM derived from: https://clinicaltrials.gov/show/NCT02040870

Link

https://clinicaltrials.gov/show/NCT02040870

Keywords

Versions (1)
  1. 1/17/19 1/17/19 -
Copyright Holder

see on clinicaltrials.gov

Uploaded on

January 17, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Non-Small Cell Lung Cancer NCT02040870

English

Eligibility Non-Small Cell Lung Cancer NCT02040870

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed diagnosis of nsclc that carries an alk rearrangement defined as positive using the fda approved vysis alk break apart fish probe kit (abbott molecular inc.) test and scoring algorithm (including positivity criteria) or positive as assessed by the cfda approved immunohistochemistry (ihc) test (ventana medical systems, inc)
Description

ID.1

Data type

boolean

age 18 years or older at the time of informed consent.
Description

ID.2

Data type

boolean

patients must have stage iiib or iv nsclc at the time of study entry and have had progressive disease during or after crizotinib treatment whether or not previously treated with cytotoxic chemotherapy. if treated with chemotherapy, maximum 2 lines are allowed.
Description

ID.3

Data type

boolean

Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with known hypersensitivity to any of the excipients of ldk378
Description

ID.4

Data type

boolean

patients with symptomatic central nervous system (cns) metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage cns symptoms
Description

ID.5

Data type

boolean

history of carcinomatous meningitis
Description

ID.6

Data type

boolean

presence or history of a malignant disease other than nsclc that has been diagnosed and/or required therapy within the past 3 years.
Description

ID.7

Data type

boolean

clinically significant, uncontrolled heart disease.
Description

ID.8

Data type

boolean

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Similar models

Eligibility Non-Small Cell Lung Cancer NCT02040870

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
histologically or cytologically confirmed diagnosis of nsclc that carries an alk rearrangement defined as positive using the fda approved vysis alk break apart fish probe kit (abbott molecular inc.) test and scoring algorithm (including positivity criteria) or positive as assessed by the cfda approved immunohistochemistry (ihc) test (ventana medical systems, inc)
boolean
ID.2
Item
age 18 years or older at the time of informed consent.
boolean
ID.3
Item
patients must have stage iiib or iv nsclc at the time of study entry and have had progressive disease during or after crizotinib treatment whether or not previously treated with cytotoxic chemotherapy. if treated with chemotherapy, maximum 2 lines are allowed.
boolean
Item Group
C0680251 (UMLS CUI)
ID.4
Item
patients with known hypersensitivity to any of the excipients of ldk378
boolean
ID.5
Item
patients with symptomatic central nervous system (cns) metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage cns symptoms
boolean
ID.6
Item
history of carcinomatous meningitis
boolean
ID.7
Item
presence or history of a malignant disease other than nsclc that has been diagnosed and/or required therapy within the past 3 years.
boolean
ID.8
Item
clinically significant, uncontrolled heart disease.
boolean
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