ID

14816

Description

A Phase 1 Study Evaluating AMG 232 in Advanced Solid Tumors or Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT01723020

Link

https://clinicaltrials.gov/show/NCT01723020

Keywords

  1. 4/29/16 4/29/16 -
Uploaded on

April 29, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Advanced Malignancy NCT01723020

Eligibility Advanced Malignancy NCT01723020

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
men or women > 18 years old
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
pathologically documented, definitively diagnosed, advanced solid tumor that is refractory to standard treatment, or which no standard therapy is available, or the subject refuses standard therapy or multiple myeloma
Description

solid tumor

Data type

boolean

Alias
UMLS CUI [1]
C0280100
willing to undergo pre-dose core needle tumor biopsies or bone marrow aspirate for subjects with multiple myeloma.
Description

needle tumor biopsy or bone marrow aspirate

Data type

boolean

Alias
UMLS CUI [1]
C1318309
UMLS CUI [2]
C1271729
ability to take oral medications and willing to record daily adherance to investigational product
Description

oral medication

Data type

boolean

Alias
UMLS CUI [1]
C0175795
adequate hematological, renal, hepatic, and coagulation laboratory assessments
Description

adequate hematological, renal, hepatic, and coagulation laboratory assessments

Data type

boolean

Alias
UMLS CUI [1]
C1254358
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
active brain metastases
Description

brain metastases

Data type

boolean

Alias
UMLS CUI [1]
C0220650
for solid tumor-history or presence of hematological malignancies unless curatively treated with no evidence of disease for greater than or equal to 5 years
Description

hematological malignancies

Data type

boolean

Alias
UMLS CUI [1]
C0376545
active infection requiring intravenous (iv) antibiotics
Description

active infection requiring intravenous (iv) antibiotics

Data type

boolean

Alias
UMLS CUI [1,1]
C0199779
UMLS CUI [1,2]
C0009450
anti-tumor therapy
Description

cancer treatment

Data type

boolean

Alias
UMLS CUI [1]
C0920425
therapeutic or palliative radiation therapy within 30 days of starting treatment
Description

radiation

Data type

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2]
C3898008
currently enrolled in another investigational device or drug study
Description

currently enrolled in another investigational device or drug study

Data type

boolean

Alias
UMLS CUI [1]
C2348568

Similar models

Eligibility Advanced Malignancy NCT01723020

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
men or women > 18 years old
boolean
C0001779 (UMLS CUI [1])
solid tumor
Item
pathologically documented, definitively diagnosed, advanced solid tumor that is refractory to standard treatment, or which no standard therapy is available, or the subject refuses standard therapy or multiple myeloma
boolean
C0280100 (UMLS CUI [1])
needle tumor biopsy or bone marrow aspirate
Item
willing to undergo pre-dose core needle tumor biopsies or bone marrow aspirate for subjects with multiple myeloma.
boolean
C1318309 (UMLS CUI [1])
C1271729 (UMLS CUI [2])
oral medication
Item
ability to take oral medications and willing to record daily adherance to investigational product
boolean
C0175795 (UMLS CUI [1])
adequate hematological, renal, hepatic, and coagulation laboratory assessments
Item
adequate hematological, renal, hepatic, and coagulation laboratory assessments
boolean
C1254358 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
brain metastases
Item
active brain metastases
boolean
C0220650 (UMLS CUI [1])
hematological malignancies
Item
for solid tumor-history or presence of hematological malignancies unless curatively treated with no evidence of disease for greater than or equal to 5 years
boolean
C0376545 (UMLS CUI [1])
active infection requiring intravenous (iv) antibiotics
Item
active infection requiring intravenous (iv) antibiotics
boolean
C0199779 (UMLS CUI [1,1])
C0009450 (UMLS CUI [1,2])
cancer treatment
Item
anti-tumor therapy
boolean
C0920425 (UMLS CUI [1])
radiation
Item
therapeutic or palliative radiation therapy within 30 days of starting treatment
boolean
C1522449 (UMLS CUI [1])
C3898008 (UMLS CUI [2])
currently enrolled in another investigational device or drug study
Item
currently enrolled in another investigational device or drug study
boolean
C2348568 (UMLS CUI [1])

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