Information:
Fel:
ID
17395
Beskrivning
Study of an Investigational Drug, ASP3026, in Patients With Advanced Malignancies (Solid Tumors and B-Cell Lymphoma); ODM derived from: https://clinicaltrials.gov/show/NCT01284192
Länk
https://clinicaltrials.gov/show/NCT01284192
Nyckelord
Versioner (1)
- 2016-09-11 2016-09-11 -
Uppladdad den
11 september 2016
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Advanced Malignancies NCT01284192
Eligibility Advanced Malignancies NCT01284192
- StudyEvent: Eligibility
Similar models
Eligibility Advanced Malignancies NCT01284192
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
ecog
Item
eastern cooperative oncology group (ecog) performance status ≤ 2
boolean
C1520224 (UMLS CUI [1])
b-cell lymphoma
Item
histologically or cytologically confirmed diagnosis of a relapsed/refractory solid tumor or b-cell lymphoma and meets at least 1 of the following criteria:
boolean
C0079731 (UMLS CUI [1])
disease progression
Item
disease progression despite standard therapies
boolean
C0242656 (UMLS CUI [1])
standard therapies
Item
no standard therapies are available or such therapies are not anticipated to result in a durable response
boolean
C2936643 (UMLS CUI [1])
oral medications
Item
able to take oral medications
boolean
C0175795 (UMLS CUI [1])
life expectancy
Item
life expectancy > 12 weeks
boolean
C0023671 (UMLS CUI [1])
alk gene abnormalities
Item
for the expansion cohort of the study, all subjects must be confirmed to be positive for alk gene abnormalities
boolean
C2825843 (UMLS CUI [1])
brain metastasis
Item
subjects with stable brain metastasis will be allowed
boolean
C0220650 (UMLS CUI [1])
central nervous system (cns) metastases
Item
active central nervous system (cns) metastases or leptomeningeal involvement as assessed through medical history review and physical examination (dose escalation subjects only)
boolean
C0279130 (UMLS CUI [1])
hepatitis b surface antigen
Item
known history of a positive test for hepatitis b surface antigen (hbsag) or hepatitis c antibody (anti-hcv)
boolean
C0019168 (UMLS CUI [1])
C0281863 (UMLS CUI [2])
C0281863 (UMLS CUI [2])
immunodeficiency syndrome , hiv
Item
known hereditary or acquired immunodeficiency syndrome or human immunodeficiency virus (hiv) infection
boolean
C0021051 (UMLS CUI [1])
C0019682 (UMLS CUI [2])
C0019682 (UMLS CUI [2])
cardiac arrhythmia
Item
cardiac arrhythmias > grade 1 using national cancer institute common terminology criteria for adverse events (nci ctcae) v. 4.03
boolean
C0003811 (UMLS CUI [1])
congestive heart failure
Item
class 3 or 4 new york heart association congestive heart failure, acute coronary syndrome, myocardial infarction or cerebrovascular accident within 6 months prior to cycle 1, day 1
boolean
C0018802 (UMLS CUI [1])
hepatic function
Item
inadequate hepatic function
boolean
C0232741 (UMLS CUI [1])
peptic ulcer disease
Item
confirmed active peptic ulcer disease or history of gastrointestinal bleeding within the past 3 months
boolean
C0030920 (UMLS CUI [1])
C0017181 (UMLS CUI [2])
C0017181 (UMLS CUI [2])
long qt syndrome
Item
known history of long qt syndrome
boolean
C0023976 (UMLS CUI [1])