ID

31211

Beskrivning

A Study to Assess the Safety and Preliminary Efficacy of PT-523 in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC); ODM derived from: https://clinicaltrials.gov/show/NCT00112060

Länk

https://clinicaltrials.gov/show/NCT00112060

Nyckelord

Versioner (1)
  1. 2018-07-29 2018-07-29 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

29 juli 2018

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Non-Small-Cell Lung Carcinoma NCT00112060

Engelsk

Eligibility Non-Small-Cell Lung Carcinoma NCT00112060

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
age ≥ 18 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
histologically or cytologically confirmed nsclc which is stage iii or stage iv, or recurrent disease, and failed therapy with a standard first line (phase i/ii) as well as second line chemotherapy regimen (phase i), or be intolerant of standard chemotherapy. receipt of one additional prior chemotherapy regimen for neoadjuvant, adjuvant, or neoadjuvant plus adjuvant is allowable. a prior epidermal growth factor receptor tyrosine kinase inhibitor (egfr-tk) antagonist is allowable (phase ii).
Beskrivning

Non-Small Cell Lung Carcinoma TNM clinical staging | Recurrent disease | First line treatment Standard failed | Second line Chemotherapy failed | Standard Chemotherapy intolerant | Prior Chemotherapy Neoadjuvant | Chemotherapy, Adjuvant | Epidermal growth factor receptor inhibitor

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
UMLS CUI [2]
C0277556
UMLS CUI [3,1]
C1708063
UMLS CUI [3,2]
C1442989
UMLS CUI [3,3]
C0231175
UMLS CUI [4,1]
C1710038
UMLS CUI [4,2]
C0392920
UMLS CUI [4,3]
C0231175
UMLS CUI [5,1]
C1442989
UMLS CUI [5,2]
C0392920
UMLS CUI [5,3]
C0231200
UMLS CUI [6,1]
C1514457
UMLS CUI [6,2]
C0600558
UMLS CUI [7]
C0085533
UMLS CUI [8]
C1443775
asymptomatic or treated brain metastases (including steroids) if last therapy was received > 4 weeks from study entry and is deemed by the investigator to have a low likelihood of rapid deterioration.
Beskrivning

Metastatic malignant neoplasm to brain Asymptomatic | Metastatic malignant neoplasm to brain Treated | Steroids

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0231221
UMLS CUI [2,1]
C0220650
UMLS CUI [2,2]
C1522326
UMLS CUI [3]
C0038317
ecog performance status 0 - 2.
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
adequate organ function and bone marrow reserve.
Beskrivning

Organ function | Bone Marrow Mature Neutrophils Present Adequate

Datatyp

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C1708947
UMLS CUI [2,3]
C0205411
use of appropriate contraceptive method.
Beskrivning

Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1]
C0700589
signed patient informed consent.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
investigational agents within 30 days prior to day 1 of study.
Beskrivning

Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
known symptomatic or uncontrolled brain metastases.
Beskrivning

Metastatic malignant neoplasm to brain Symptomatic | Metastatic malignant neoplasm to brain Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C0220650
UMLS CUI [2,2]
C0205318
uncontrolled intercurrent illness.
Beskrivning

Comorbidity Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
known human immunodeficiency virus (hiv), hepatitis a, b, c, d and e.
Beskrivning

HIV Infection | Hepatitis A | Hepatitis B | Hepatitis C | Hepatitis D Infection | Hepatitis E

Datatyp

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0019159
UMLS CUI [3]
C0019163
UMLS CUI [4]
C0019196
UMLS CUI [5]
C0011226
UMLS CUI [6]
C0085293
patient has uncontrolled pleural effusions.
Beskrivning

Pleural effusion Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0032227
UMLS CUI [1,2]
C0205318
patient has received nitrosoureas or mitomycin-c within 6 weeks or other chemotherapy or radiation therapy within 3 weeks before study entry.
Beskrivning

Nitrosoureas | Mitomycin | Chemotherapy | Therapeutic radiology procedure

Datatyp

boolean

Alias
UMLS CUI [1]
C0028210
UMLS CUI [2]
C0002475
UMLS CUI [3]
C0392920
UMLS CUI [4]
C1522449
Tillbaka till toppen

Similar models

Eligibility Non-Small-Cell Lung Carcinoma NCT00112060

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
Non-Small Cell Lung Carcinoma TNM clinical staging | Recurrent disease | First line treatment Standard failed | Second line Chemotherapy failed | Standard Chemotherapy intolerant | Prior Chemotherapy Neoadjuvant | Chemotherapy, Adjuvant | Epidermal growth factor receptor inhibitor
Item
histologically or cytologically confirmed nsclc which is stage iii or stage iv, or recurrent disease, and failed therapy with a standard first line (phase i/ii) as well as second line chemotherapy regimen (phase i), or be intolerant of standard chemotherapy. receipt of one additional prior chemotherapy regimen for neoadjuvant, adjuvant, or neoadjuvant plus adjuvant is allowable. a prior epidermal growth factor receptor tyrosine kinase inhibitor (egfr-tk) antagonist is allowable (phase ii).
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0277556 (UMLS CUI [2])
C1708063 (UMLS CUI [3,1])
C1442989 (UMLS CUI [3,2])
C0231175 (UMLS CUI [3,3])
C1710038 (UMLS CUI [4,1])
C0392920 (UMLS CUI [4,2])
C0231175 (UMLS CUI [4,3])
C1442989 (UMLS CUI [5,1])
C0392920 (UMLS CUI [5,2])
C0231200 (UMLS CUI [5,3])
C1514457 (UMLS CUI [6,1])
C0600558 (UMLS CUI [6,2])
C0085533 (UMLS CUI [7])
C1443775 (UMLS CUI [8])
Metastatic malignant neoplasm to brain Asymptomatic | Metastatic malignant neoplasm to brain Treated | Steroids
Item
asymptomatic or treated brain metastases (including steroids) if last therapy was received > 4 weeks from study entry and is deemed by the investigator to have a low likelihood of rapid deterioration.
boolean
C0220650 (UMLS CUI [1,1])
C0231221 (UMLS CUI [1,2])
C0220650 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C0038317 (UMLS CUI [3])
ECOG performance status
Item
ecog performance status 0 - 2.
boolean
C1520224 (UMLS CUI [1])
Organ function | Bone Marrow Mature Neutrophils Present Adequate
Item
adequate organ function and bone marrow reserve.
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C1708947 (UMLS CUI [2,2])
C0205411 (UMLS CUI [2,3])
Contraceptive methods
Item
use of appropriate contraceptive method.
boolean
C0700589 (UMLS CUI [1])
Informed Consent
Item
signed patient informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Investigational New Drugs
Item
investigational agents within 30 days prior to day 1 of study.
boolean
C0013230 (UMLS CUI [1])
Metastatic malignant neoplasm to brain Symptomatic | Metastatic malignant neoplasm to brain Uncontrolled
Item
known symptomatic or uncontrolled brain metastases.
boolean
C0220650 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0220650 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Comorbidity Uncontrolled
Item
uncontrolled intercurrent illness.
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
HIV Infection | Hepatitis A | Hepatitis B | Hepatitis C | Hepatitis D Infection | Hepatitis E
Item
known human immunodeficiency virus (hiv), hepatitis a, b, c, d and e.
boolean
C0019693 (UMLS CUI [1])
C0019159 (UMLS CUI [2])
C0019163 (UMLS CUI [3])
C0019196 (UMLS CUI [4])
C0011226 (UMLS CUI [5])
C0085293 (UMLS CUI [6])
Pleural effusion Uncontrolled
Item
patient has uncontrolled pleural effusions.
boolean
C0032227 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Nitrosoureas | Mitomycin | Chemotherapy | Therapeutic radiology procedure
Item
patient has received nitrosoureas or mitomycin-c within 6 weeks or other chemotherapy or radiation therapy within 3 weeks before study entry.
boolean
C0028210 (UMLS CUI [1])
C0002475 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
C1522449 (UMLS CUI [4])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial