ID

37229

Beschreibung

Phase 1-2 Study of ASTX660 in Subjects With Advanced Solid Tumors and Lymphomas; ODM derived from: https://clinicaltrials.gov/show/NCT02503423

Link

https://clinicaltrials.gov/show/NCT02503423

Stichworte

Versionen (1)
  1. 09.07.19 09.07.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

9. Juli 2019

DOI

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Creative Commons BY 4.0
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Eligibility Solid Tumors NCT02503423

Englisch

Eligibility Solid Tumors NCT02503423

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects with histologically or cytologically confirmed advanced solid tumors or lymphoma and for whom standard life-prolonging measures are not available.
Beschreibung

Advanced Malignant Solid Neoplasm | Lymphoma Advanced | Life prolongation Standard of Care Unavailable

Datentyp

boolean

Alias
UMLS CUI [1]
C4329281
UMLS CUI [2,1]
C0024299
UMLS CUI [2,2]
C0205179
UMLS CUI [3,1]
C0023677
UMLS CUI [3,2]
C2936643
UMLS CUI [3,3]
C0686905
eastern cooperative oncology group: 0 to 2
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
hypersensitivity to astx660, excipients of the drug product, or other components of the study treatment regimen
Beschreibung

Hypersensitivity ASTX660 | Hypersensitivity ASTX660 Excipient | Hypersensitivity Investigational Therapy Component

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C4086975
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C4086975
UMLS CUI [2,3]
C0015237
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0949266
UMLS CUI [3,3]
C1705248
uncontrolled medical disease(s) or active, uncontrolled infections
Beschreibung

Disease Uncontrolled | Communicable Disease Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0205318
life-threatening illness or significant organ system dysfunction
Beschreibung

Life threatening illness | Organ system Dysfunction

Datentyp

boolean

Alias
UMLS CUI [1]
C3846017
UMLS CUI [2,1]
C0460002
UMLS CUI [2,2]
C3887504
a history of, or at risk for, cardiac disease
Beschreibung

Heart Disease | At risk Heart Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2,1]
C1444641
UMLS CUI [2,2]
C0018799
known history of hiv, or hepatitis b (hbv) or c (hcv)
Beschreibung

HIV Infection | Hepatitis B | Hepatitis C

Datentyp

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
grade 2 or greater neuropathy
Beschreibung

Neuropathy CTCAE Grades

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0442874
UMLS CUI [1,2]
C1516728
known brain metastases unless stable or previously treated
Beschreibung

Metastatic malignant neoplasm to brain | Exception Stable status | Exception Metastatic malignant neoplasm to brain Treated

Datentyp

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0205360
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0220650
UMLS CUI [3,3]
C1522326
known significant mental illness
Beschreibung

Mental disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C0004936
prior anticancer treatments or therapies within specified time windows prior to first dose of study treatment (astx660)
Beschreibung

Cancer treatment Previous

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205156
pregnant or nursing an infant
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Ähnliche Modelle

Eligibility Solid Tumors NCT02503423

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Advanced Malignant Solid Neoplasm | Lymphoma Advanced | Life prolongation Standard of Care Unavailable
Item
subjects with histologically or cytologically confirmed advanced solid tumors or lymphoma and for whom standard life-prolonging measures are not available.
boolean
C4329281 (UMLS CUI [1])
C0024299 (UMLS CUI [2,1])
C0205179 (UMLS CUI [2,2])
C0023677 (UMLS CUI [3,1])
C2936643 (UMLS CUI [3,2])
C0686905 (UMLS CUI [3,3])
ECOG performance status
Item
eastern cooperative oncology group: 0 to 2
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity ASTX660 | Hypersensitivity ASTX660 Excipient | Hypersensitivity Investigational Therapy Component
Item
hypersensitivity to astx660, excipients of the drug product, or other components of the study treatment regimen
boolean
C0020517 (UMLS CUI [1,1])
C4086975 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C4086975 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0949266 (UMLS CUI [3,2])
C1705248 (UMLS CUI [3,3])
Disease Uncontrolled | Communicable Disease Uncontrolled
Item
uncontrolled medical disease(s) or active, uncontrolled infections
boolean
C0012634 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Life threatening illness | Organ system Dysfunction
Item
life-threatening illness or significant organ system dysfunction
boolean
C3846017 (UMLS CUI [1])
C0460002 (UMLS CUI [2,1])
C3887504 (UMLS CUI [2,2])
Heart Disease | At risk Heart Disease
Item
a history of, or at risk for, cardiac disease
boolean
C0018799 (UMLS CUI [1])
C1444641 (UMLS CUI [2,1])
C0018799 (UMLS CUI [2,2])
HIV Infection | Hepatitis B | Hepatitis C
Item
known history of hiv, or hepatitis b (hbv) or c (hcv)
boolean
C0019693 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
Neuropathy CTCAE Grades
Item
grade 2 or greater neuropathy
boolean
C0442874 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Metastatic malignant neoplasm to brain | Exception Stable status | Exception Metastatic malignant neoplasm to brain Treated
Item
known brain metastases unless stable or previously treated
boolean
C0220650 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0220650 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
Mental disorder
Item
known significant mental illness
boolean
C0004936 (UMLS CUI [1])
Cancer treatment Previous
Item
prior anticancer treatments or therapies within specified time windows prior to first dose of study treatment (astx660)
boolean
C0920425 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnant or nursing an infant
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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