ID

16463

Beschreibung

Safety and Efficacy Clinical Study of SNS-595 for Second-Line Therapy in Patients With Advanced NSCLC; ODM derived from: https://clinicaltrials.gov/show/NCT00252382

Link

https://clinicaltrials.gov/show/NCT00252382

Stichworte

Versionen (1)
  1. 17.07.16 17.07.16 -
Hochgeladen am

17. Juli 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Carcinoma, Non-Small-Cell Lung NCT00252382

Englisch

Eligibility Carcinoma, Non-Small-Cell Lung NCT00252382

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
able to understand and willing to sign a written informed consent document
Beschreibung

Written informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
patients who have recurrent or metastatic nsclc, who have failed initial therapy with a platinum-containing regimen and have not received any second-line therapy (adjuvant therapy is acceptable if it was completed greater than or equal to 12 months before the cancer recurrence)
Beschreibung

NSCLC

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0438286
measurable disease
Beschreibung

Measurable disease

Datentyp

boolean

Alias
UMLS CUI [1]
C1513041
eastern cooperative oncology group (ecog) performance status score of 0 or 1
Beschreibung

ECOG

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
laboratory values within the normal or reasonable reference range as specified by the protocol
Beschreibung

laboratory values

Datentyp

boolean

Alias
UMLS CUI [1]
C0022885
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior exposure to sns-595
Beschreibung

prior exposure to sns-595

Datentyp

boolean

Alias
UMLS CUI [1]
C1541378
pregnant or breastfeeding
Beschreibung

pregnant or breastfeeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
women of childbearing potential or male partners of women of childbearing potential unwilling to use an approved, effective means of contraception according to the institution's standards
Beschreibung

childbearing potential

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
other active malignancies or other malignancies within the past 12 months except non-melanoma skin cancer, cervical intraepithelial neoplasia or prostatic intraepithelial neoplasia
Beschreibung

Malignancies

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
brain metastases, if present, without radiologic evidence of progressive disease for at least 3 months after completion of therapy
Beschreibung

Brain metastases

Datentyp

boolean

Alias
UMLS CUI [1]
C0220650
myocardial infarction, cerebrovascular accident/transient ischemic attack (tia) or thromboembolic event (deep vein thrombosis or pulmonary embolus) within 6 months before the first sns-595 dose
Beschreibung

myocardial infarction, cerebrovascular accident/transient ischemic attack (tia) or thromboembolic event

Datentyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0007787
UMLS CUI [4]
C0040038
requires kidney dialysis (hemodialysis or peritoneal)
Beschreibung

Renal dialysis

Datentyp

boolean

Alias
UMLS CUI [1]
C0011946
prior chemotherapy, investigational agents, or radiation therapy within 28 days before cycle 1 day 0; however, nitrosoureas and mitomycin are not permitted for at least 42 days before cycle 1 day 0
Beschreibung

prior chemotherapy, investigational agents, or radiation therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0013230
UMLS CUI [3]
C1522449
in patients with toxicities caused by prior cancer therapy, those toxicities must have returned to less than or equal to grade 1, with the exception of alopecia
Beschreibung

Toxicity

Datentyp

boolean

Alias
UMLS CUI [1]
C0013221
prior pelvic radiation therapy or radiation to greater than or equal to 25% of bone marrow reserve (prior palliative radiation is permitted as long as it does not exceed 25% of bone marrow reserve)
Beschreibung

Radiation therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C1522449
any other medical, psychological, or social condition that, in the opinion of the principal investigator, would contraindicate the patient's participation in the clinical trial due to safety concerns or compliance with study procedures
Beschreibung

other medical, psychological, or social condition

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
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Ähnliche Modelle

Eligibility Carcinoma, Non-Small-Cell Lung NCT00252382

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Written informed consent
Item
able to understand and willing to sign a written informed consent document
boolean
C0021430 (UMLS CUI [1])
NSCLC
Item
patients who have recurrent or metastatic nsclc, who have failed initial therapy with a platinum-containing regimen and have not received any second-line therapy (adjuvant therapy is acceptable if it was completed greater than or equal to 12 months before the cancer recurrence)
boolean
C0007131 (UMLS CUI [1,1])
C0438286 (UMLS CUI [1,2])
Measurable disease
Item
measurable disease
boolean
C1513041 (UMLS CUI [1])
ECOG
Item
eastern cooperative oncology group (ecog) performance status score of 0 or 1
boolean
C1520224 (UMLS CUI [1])
laboratory values
Item
laboratory values within the normal or reasonable reference range as specified by the protocol
boolean
C0022885 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
prior exposure to sns-595
Item
prior exposure to sns-595
boolean
C1541378 (UMLS CUI [1])
pregnant or breastfeeding
Item
pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
childbearing potential
Item
women of childbearing potential or male partners of women of childbearing potential unwilling to use an approved, effective means of contraception according to the institution's standards
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Malignancies
Item
other active malignancies or other malignancies within the past 12 months except non-melanoma skin cancer, cervical intraepithelial neoplasia or prostatic intraepithelial neoplasia
boolean
C0006826 (UMLS CUI [1])
Brain metastases
Item
brain metastases, if present, without radiologic evidence of progressive disease for at least 3 months after completion of therapy
boolean
C0220650 (UMLS CUI [1])
myocardial infarction, cerebrovascular accident/transient ischemic attack (tia) or thromboembolic event
Item
myocardial infarction, cerebrovascular accident/transient ischemic attack (tia) or thromboembolic event (deep vein thrombosis or pulmonary embolus) within 6 months before the first sns-595 dose
boolean
C0027051 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0007787 (UMLS CUI [3])
C0040038 (UMLS CUI [4])
Renal dialysis
Item
requires kidney dialysis (hemodialysis or peritoneal)
boolean
C0011946 (UMLS CUI [1])
prior chemotherapy, investigational agents, or radiation therapy
Item
prior chemotherapy, investigational agents, or radiation therapy within 28 days before cycle 1 day 0; however, nitrosoureas and mitomycin are not permitted for at least 42 days before cycle 1 day 0
boolean
C0392920 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
Toxicity
Item
in patients with toxicities caused by prior cancer therapy, those toxicities must have returned to less than or equal to grade 1, with the exception of alopecia
boolean
C0013221 (UMLS CUI [1])
Radiation therapy
Item
prior pelvic radiation therapy or radiation to greater than or equal to 25% of bone marrow reserve (prior palliative radiation is permitted as long as it does not exceed 25% of bone marrow reserve)
boolean
C1522449 (UMLS CUI [1])
other medical, psychological, or social condition
Item
any other medical, psychological, or social condition that, in the opinion of the principal investigator, would contraindicate the patient's participation in the clinical trial due to safety concerns or compliance with study procedures
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
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