ID

31211

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT00112060

Stichworte

Versionen (1)
  1. 29.07.18 29.07.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

29. Juli 2018

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Non-Small-Cell Lung Carcinoma NCT00112060

Englisch

Eligibility Non-Small-Cell Lung Carcinoma NCT00112060

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
age ≥ 18 years
Beschreibung

Age

Datentyp

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).
Beschreibung

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

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

ECOG performance status

Datentyp

boolean

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

Organ function | Bone Marrow Mature Neutrophils Present Adequate

Datentyp

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.
Beschreibung

Contraceptive methods

Datentyp

boolean

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

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

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

Investigational New Drugs

Datentyp

boolean

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

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

Datentyp

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.
Beschreibung

Comorbidity Uncontrolled

Datentyp

boolean

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

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

Datentyp

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.
Beschreibung

Pleural effusion Uncontrolled

Datentyp

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.
Beschreibung

Nitrosoureas | Mitomycin | Chemotherapy | Therapeutic radiology procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C0028210
UMLS CUI [2]
C0002475
UMLS CUI [3]
C0392920
UMLS CUI [4]
C1522449
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Ähnliche Modelle

Eligibility Non-Small-Cell Lung Carcinoma NCT00112060

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
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