ID

31216

Beschreibung

A Study of the Safety and Pharmacology Of PI3-Kinase Inhibitor GDC-0941 In Combination With Either Paclitaxel And Carboplatin (With or Without Bevacizumab) or Pemetrexed, Cisplatin, And Bevacizumab in Patients With Advanced Non-Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00974584

Link

https://clinicaltrials.gov/show/NCT00974584

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-Squamous Non-Small Cell Lung Cancer NCT00974584

Englisch

Eligibility Non-Squamous Non-Small Cell Lung Cancer NCT00974584

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically documented nsclc with advanced disease (stage iiib not eligible for chemoradiotherapy or stage iv or recurrent disease)
Beschreibung

Non-Small Cell Lung Carcinoma Advanced TNM clinical staging | Ineligibility Chemoradiotherapy | Non-Small Cell Lung Carcinoma TNM clinical staging | Non-small cell lung cancer recurrent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C3258246
UMLS CUI [2,1]
C1512714
UMLS CUI [2,2]
C0436307
UMLS CUI [3,1]
C0007131
UMLS CUI [3,2]
C3258246
UMLS CUI [4]
C0278517
adequate organ function as assessed by laboratory tests
Beschreibung

Organ function Laboratory tests

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0678852
UMLS CUI [1,2]
C0022885
evaluable disease or disease measurable per response evaluation criteria in solid tumors (recist)
Beschreibung

Evaluable Disease | Measurable Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C1516986
UMLS CUI [2]
C1513041
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
more than one anti-cancer regimen (chemotherapy or radiotherapy) for advanced nsclc prior to initiation of study treatment
Beschreibung

Cancer treatment Quantity Non-Small Cell Lung Carcinoma Advanced | Chemotherapy | Therapeutic radiology procedure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0007131
UMLS CUI [1,4]
C0205179
UMLS CUI [2]
C0392920
UMLS CUI [3]
C1522449
any adjuvant or neoadjuvant anti-cancer therapy within a specified timeframe prior to first study treatment
Beschreibung

Cancer treatment Adjuvant | Cancer treatment Neoadjuvant

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C1522673
UMLS CUI [2,1]
C0920425
UMLS CUI [2,2]
C0600558
history of grade >= 3 fasting hyperglycemia or diabetes requiring regular medication
Beschreibung

Fasting hyperglycaemia CTCAE Grades | Diabetes Mellitus Requirement Pharmaceutical Preparations Regular

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2609269
UMLS CUI [1,2]
C1516728
UMLS CUI [2,1]
C0011849
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0013227
UMLS CUI [2,4]
C0205272
active autoimmune disease, active infection requiring iv antibiotics, or other current uncontrolled illness
Beschreibung

Autoimmune Disease | Communicable Disease Requirement Antibiotics Intravenous | Illness Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0003232
UMLS CUI [2,4]
C1522726
UMLS CUI [3,1]
C0221423
UMLS CUI [3,2]
C0205318
history of clinically significant cardiac or pulmonary dysfunction
Beschreibung

Cardiac dysfunction | Pulmonary Dysfunction

Datentyp

boolean

Alias
UMLS CUI [1]
C3277906
UMLS CUI [2]
C1709770
history of malabsorption syndrome or other condition that would interfere with enteral absorption
Beschreibung

Malabsorption Syndrome | Condition Interferes with Intestinal Absorption

Datentyp

boolean

Alias
UMLS CUI [1]
C0024523
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0021826
clinically significant history of liver disease
Beschreibung

Liver disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0023895
any condition requiring full-dose anticoagulants, such as warfarin, heparin, or thrombolytic agents
Beschreibung

Condition Requirement Anticoagulants Dose Full | Warfarin | Heparin | Fibrinolytic Agents

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0003280
UMLS CUI [1,4]
C0178602
UMLS CUI [1,5]
C0443225
UMLS CUI [2]
C0043031
UMLS CUI [3]
C0019134
UMLS CUI [4]
C0016018
known brain metastases that are untreated, symptomatic, or require therapy
Beschreibung

Metastatic malignant neoplasm to brain untreated | Metastatic malignant neoplasm to brain Symptomatic | Metastatic malignant neoplasm to brain Treatment required for

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C0220650
UMLS CUI [2,2]
C0231220
UMLS CUI [3,1]
C0220650
UMLS CUI [3,2]
C0332121
pregnancy, lactation, or breastfeeding
Beschreibung

Pregnancy | Lactation | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0022925
UMLS CUI [3]
C0006147
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Ähnliche Modelle

Eligibility Non-Squamous Non-Small Cell Lung Cancer NCT00974584

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma Advanced TNM clinical staging | Ineligibility Chemoradiotherapy | Non-Small Cell Lung Carcinoma TNM clinical staging | Non-small cell lung cancer recurrent
Item
histologically or cytologically documented nsclc with advanced disease (stage iiib not eligible for chemoradiotherapy or stage iv or recurrent disease)
boolean
C0007131 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
C1512714 (UMLS CUI [2,1])
C0436307 (UMLS CUI [2,2])
C0007131 (UMLS CUI [3,1])
C3258246 (UMLS CUI [3,2])
C0278517 (UMLS CUI [4])
Organ function Laboratory tests
Item
adequate organ function as assessed by laboratory tests
boolean
C0678852 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
Evaluable Disease | Measurable Disease
Item
evaluable disease or disease measurable per response evaluation criteria in solid tumors (recist)
boolean
C1516986 (UMLS CUI [1])
C1513041 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Cancer treatment Quantity Non-Small Cell Lung Carcinoma Advanced | Chemotherapy | Therapeutic radiology procedure
Item
more than one anti-cancer regimen (chemotherapy or radiotherapy) for advanced nsclc prior to initiation of study treatment
boolean
C0920425 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0007131 (UMLS CUI [1,3])
C0205179 (UMLS CUI [1,4])
C0392920 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
Cancer treatment Adjuvant | Cancer treatment Neoadjuvant
Item
any adjuvant or neoadjuvant anti-cancer therapy within a specified timeframe prior to first study treatment
boolean
C0920425 (UMLS CUI [1,1])
C1522673 (UMLS CUI [1,2])
C0920425 (UMLS CUI [2,1])
C0600558 (UMLS CUI [2,2])
Fasting hyperglycaemia CTCAE Grades | Diabetes Mellitus Requirement Pharmaceutical Preparations Regular
Item
history of grade >= 3 fasting hyperglycemia or diabetes requiring regular medication
boolean
C2609269 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C0011849 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0013227 (UMLS CUI [2,3])
C0205272 (UMLS CUI [2,4])
Autoimmune Disease | Communicable Disease Requirement Antibiotics Intravenous | Illness Uncontrolled
Item
active autoimmune disease, active infection requiring iv antibiotics, or other current uncontrolled illness
boolean
C0004364 (UMLS CUI [1])
C0009450 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0003232 (UMLS CUI [2,3])
C1522726 (UMLS CUI [2,4])
C0221423 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
Cardiac dysfunction | Pulmonary Dysfunction
Item
history of clinically significant cardiac or pulmonary dysfunction
boolean
C3277906 (UMLS CUI [1])
C1709770 (UMLS CUI [2])
Malabsorption Syndrome | Condition Interferes with Intestinal Absorption
Item
history of malabsorption syndrome or other condition that would interfere with enteral absorption
boolean
C0024523 (UMLS CUI [1])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0021826 (UMLS CUI [2,3])
Liver disease
Item
clinically significant history of liver disease
boolean
C0023895 (UMLS CUI [1])
Condition Requirement Anticoagulants Dose Full | Warfarin | Heparin | Fibrinolytic Agents
Item
any condition requiring full-dose anticoagulants, such as warfarin, heparin, or thrombolytic agents
boolean
C0348080 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0003280 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,4])
C0443225 (UMLS CUI [1,5])
C0043031 (UMLS CUI [2])
C0019134 (UMLS CUI [3])
C0016018 (UMLS CUI [4])
Metastatic malignant neoplasm to brain untreated | Metastatic malignant neoplasm to brain Symptomatic | Metastatic malignant neoplasm to brain Treatment required for
Item
known brain metastases that are untreated, symptomatic, or require therapy
boolean
C0220650 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0220650 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0220650 (UMLS CUI [3,1])
C0332121 (UMLS CUI [3,2])
Pregnancy | Lactation | Breast Feeding
Item
pregnancy, lactation, or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0022925 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
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