ID

31112

Beskrivning

A Randomized Phase 2 Study of AT-101 in Combination With Docetaxel in Relapsed/Refractory Non-Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00544960

Länk

https://clinicaltrials.gov/show/NCT00544960

Nyckelord

Versioner (1)
  1. 2018-07-20 2018-07-20 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

20 juli 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Non-small Cell Lung Cancer NCT00544960

Engelsk

Eligibility Non-small Cell Lung Cancer NCT00544960

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed stage iiib with pleural/pericardial effusion or stage iv non-small cell lung cancer (nsclc).
Beskrivning

Non-Small Cell Lung Carcinoma TNM clinical staging | Pleural effusion disorder | Pericardial effusion

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
UMLS CUI [2]
C0032227
UMLS CUI [3]
C0031039
progression of disease after one prior systemic chemotherapeutic regimen for locally advanced or metastatic nsclc. (systemic therapies given in the adjuvant setting are counted only if the patient relapses within 6 months of the last cycle of therapy.) in addition to the one prior chemotherapeutic regimen, patients may have received erlotinib in any setting.
Beskrivning

Disease Progression | Systemic Chemotherapy Quantity | Non-Small Cell Lung Carcinoma Advanced Locally | Systemic Chemotherapy Quantity Non-small cell lung cancer metastatic | erlotinib

Datatyp

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2,1]
C1883256
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C0007131
UMLS CUI [3,2]
C0205179
UMLS CUI [3,3]
C1517927
UMLS CUI [4,1]
C1883256
UMLS CUI [4,2]
C1265611
UMLS CUI [4,3]
C0278987
UMLS CUI [5]
C1135135
all patients must have measurable disease.
Beskrivning

Measurable Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C1513041
no unstable or progressive brain metastases.
Beskrivning

Metastatic malignant neoplasm to brain Unstable Absent | Metastatic malignant neoplasm to brain Progressive Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0443343
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0220650
UMLS CUI [2,2]
C0205329
UMLS CUI [2,3]
C0332197
patients may have received prior radiation therapy but they must have recovered from all treatment-related toxicities.
Beskrivning

Prior radiation therapy | Toxicity Treatment Related | Patient recovered

Datatyp

boolean

Alias
UMLS CUI [1]
C0279134
UMLS CUI [2,1]
C0600688
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C0439849
UMLS CUI [3]
C1115804
ecog performance status 0-1
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
adequate hematologic function
Beskrivning

Hematologic function

Datatyp

boolean

Alias
UMLS CUI [1]
C0221130
adequate liver and renal function
Beskrivning

Liver function | Renal function

Datatyp

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
ability to swallow oral medication
Beskrivning

Able to swallow Oral medication

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0175795
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior chemotherapy regimen containing docetaxel.
Beskrivning

Prior Chemotherapy Containing Docetaxel

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0332256
UMLS CUI [1,3]
C0246415
active secondary malignancy.
Beskrivning

Secondary Malignant Neoplasm

Datatyp

boolean

Alias
UMLS CUI [1]
C3266877
uncontrolled concurrent illness including, but not limited to: serious uncontrolled infection, symptomatic congestive heart failure (chf), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with the study requirements.
Beskrivning

Comorbidity Uncontrolled | Communicable Disease Serious Uncontrolled | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C0205318
UMLS CUI [3]
C0742758
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0003811
UMLS CUI [6,1]
C0004936
UMLS CUI [6,2]
C0439801
UMLS CUI [6,3]
C0525058
UMLS CUI [7,1]
C0748872
UMLS CUI [7,2]
C0439801
UMLS CUI [7,3]
C0525058
failure to recover from toxicities related to prior therapy (e.g., surgery, radiation, chemotherapy).
Beskrivning

Toxicity Prior Therapy Related | Operative Surgical Procedures | Therapeutic radiology procedure | Chemotherapy | Recovery failed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C1514463
UMLS CUI [1,3]
C0439849
UMLS CUI [2]
C0543467
UMLS CUI [3]
C1522449
UMLS CUI [4]
C0392920
UMLS CUI [5,1]
C2004454
UMLS CUI [5,2]
C0231175
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Similar models

Eligibility Non-small Cell Lung Cancer NCT00544960

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma TNM clinical staging | Pleural effusion disorder | Pericardial effusion
Item
histologically or cytologically confirmed stage iiib with pleural/pericardial effusion or stage iv non-small cell lung cancer (nsclc).
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0032227 (UMLS CUI [2])
C0031039 (UMLS CUI [3])
Disease Progression | Systemic Chemotherapy Quantity | Non-Small Cell Lung Carcinoma Advanced Locally | Systemic Chemotherapy Quantity Non-small cell lung cancer metastatic | erlotinib
Item
progression of disease after one prior systemic chemotherapeutic regimen for locally advanced or metastatic nsclc. (systemic therapies given in the adjuvant setting are counted only if the patient relapses within 6 months of the last cycle of therapy.) in addition to the one prior chemotherapeutic regimen, patients may have received erlotinib in any setting.
boolean
C0242656 (UMLS CUI [1])
C1883256 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0007131 (UMLS CUI [3,1])
C0205179 (UMLS CUI [3,2])
C1517927 (UMLS CUI [3,3])
C1883256 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C0278987 (UMLS CUI [4,3])
C1135135 (UMLS CUI [5])
Measurable Disease
Item
all patients must have measurable disease.
boolean
C1513041 (UMLS CUI [1])
Metastatic malignant neoplasm to brain Unstable Absent | Metastatic malignant neoplasm to brain Progressive Absent
Item
no unstable or progressive brain metastases.
boolean
C0220650 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0220650 (UMLS CUI [2,1])
C0205329 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Prior radiation therapy | Toxicity Treatment Related | Patient recovered
Item
patients may have received prior radiation therapy but they must have recovered from all treatment-related toxicities.
boolean
C0279134 (UMLS CUI [1])
C0600688 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
C1115804 (UMLS CUI [3])
ECOG performance status
Item
ecog performance status 0-1
boolean
C1520224 (UMLS CUI [1])
Hematologic function
Item
adequate hematologic function
boolean
C0221130 (UMLS CUI [1])
Liver function | Renal function
Item
adequate liver and renal function
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
Able to swallow Oral medication
Item
ability to swallow oral medication
boolean
C2712086 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Prior Chemotherapy Containing Docetaxel
Item
prior chemotherapy regimen containing docetaxel.
boolean
C1514457 (UMLS CUI [1,1])
C0332256 (UMLS CUI [1,2])
C0246415 (UMLS CUI [1,3])
Secondary Malignant Neoplasm
Item
active secondary malignancy.
boolean
C3266877 (UMLS CUI [1])
Comorbidity Uncontrolled | Communicable Disease Serious Uncontrolled | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance
Item
uncontrolled concurrent illness including, but not limited to: serious uncontrolled infection, symptomatic congestive heart failure (chf), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with the study requirements.
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0205318 (UMLS CUI [2,3])
C0742758 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5])
C0004936 (UMLS CUI [6,1])
C0439801 (UMLS CUI [6,2])
C0525058 (UMLS CUI [6,3])
C0748872 (UMLS CUI [7,1])
C0439801 (UMLS CUI [7,2])
C0525058 (UMLS CUI [7,3])
Toxicity Prior Therapy Related | Operative Surgical Procedures | Therapeutic radiology procedure | Chemotherapy | Recovery failed
Item
failure to recover from toxicities related to prior therapy (e.g., surgery, radiation, chemotherapy).
boolean
C0600688 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0543467 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C0392920 (UMLS CUI [4])
C2004454 (UMLS CUI [5,1])
C0231175 (UMLS CUI [5,2])
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