ID

17395

Description

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

Link

https://clinicaltrials.gov/show/NCT01284192

Keywords

  1. 9/11/16 9/11/16 -
Uploaded on

September 11, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Advanced Malignancies NCT01284192

Eligibility Advanced Malignancies NCT01284192

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
eastern cooperative oncology group (ecog) performance status ≤ 2
Description

ecog

Data type

boolean

Alias
UMLS CUI [1]
C1520224
histologically or cytologically confirmed diagnosis of a relapsed/refractory solid tumor or b-cell lymphoma and meets at least 1 of the following criteria:
Description

b-cell lymphoma

Data type

boolean

Alias
UMLS CUI [1]
C0079731
disease progression despite standard therapies
Description

disease progression

Data type

boolean

Alias
UMLS CUI [1]
C0242656
no standard therapies are available or such therapies are not anticipated to result in a durable response
Description

standard therapies

Data type

boolean

Alias
UMLS CUI [1]
C2936643
able to take oral medications
Description

oral medications

Data type

boolean

Alias
UMLS CUI [1]
C0175795
life expectancy > 12 weeks
Description

life expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
for the expansion cohort of the study, all subjects must be confirmed to be positive for alk gene abnormalities
Description

alk gene abnormalities

Data type

boolean

Alias
UMLS CUI [1]
C2825843
subjects with stable brain metastasis will be allowed
Description

brain metastasis

Data type

boolean

Alias
UMLS CUI [1]
C0220650
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
active central nervous system (cns) metastases or leptomeningeal involvement as assessed through medical history review and physical examination (dose escalation subjects only)
Description

central nervous system (cns) metastases

Data type

boolean

Alias
UMLS CUI [1]
C0279130
known history of a positive test for hepatitis b surface antigen (hbsag) or hepatitis c antibody (anti-hcv)
Description

hepatitis b surface antigen

Data type

boolean

Alias
UMLS CUI [1]
C0019168
UMLS CUI [2]
C0281863
known hereditary or acquired immunodeficiency syndrome or human immunodeficiency virus (hiv) infection
Description

immunodeficiency syndrome , hiv

Data type

boolean

Alias
UMLS CUI [1]
C0021051
UMLS CUI [2]
C0019682
cardiac arrhythmias > grade 1 using national cancer institute common terminology criteria for adverse events (nci ctcae) v. 4.03
Description

cardiac arrhythmia

Data type

boolean

Alias
UMLS CUI [1]
C0003811
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
Description

congestive heart failure

Data type

boolean

Alias
UMLS CUI [1]
C0018802
inadequate hepatic function
Description

hepatic function

Data type

boolean

Alias
UMLS CUI [1]
C0232741
confirmed active peptic ulcer disease or history of gastrointestinal bleeding within the past 3 months
Description

peptic ulcer disease

Data type

boolean

Alias
UMLS CUI [1]
C0030920
UMLS CUI [2]
C0017181
known history of long qt syndrome
Description

long qt syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0023976

Similar models

Eligibility Advanced Malignancies NCT01284192

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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])
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])
long qt syndrome
Item
known history of long qt syndrome
boolean
C0023976 (UMLS CUI [1])

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