ID

27383

Beskrivning

Safety Study of XL765 (SAR245409) in Combination With Erlotinib in Adults With Solid Tumors; ODM derived from: https://clinicaltrials.gov/show/NCT00777699

Länk

https://clinicaltrials.gov/show/NCT00777699

Nyckelord

Versioner (1)
  1. 2017-11-10 2017-11-10 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

10 november 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Cancer NCT00777699

Engelsk

Eligibility Cancer NCT00777699

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Cancer NCT00777699
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
confirmed diagnosis of:
Beskrivning

Diagnosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0011900
advanced solid tumor that is no longer responding to therapies or
Beskrivning

Solid tumour Advanced Unresponsive to Treatment

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0280100
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C0205269
advanced or metastatic nsclc that has previously been treated with erlotinib or gefitinib
Beskrivning

Prior Therapy Non-Small Cell Lung Carcinoma Advanced | Prior Therapy Non-small cell lung cancer metastatic | erlotinib | gefitinib

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0007131
UMLS CUI [1,3]
C0205179
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C0278987
UMLS CUI [3]
C1135135
UMLS CUI [4]
C1122962
ecog performance status 0-1
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
adequate organ and bone arrow function as defined by hematological and serum chemistry limits
Beskrivning

Organ function Hematologic | Bone Marrow function Hematologic | Organ function Serum Chemistry Measurement | Bone Marrow function Serum Chemistry Measurement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0678852
UMLS CUI [1,2]
C0205488
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
UMLS CUI [2,3]
C0205488
UMLS CUI [3,1]
C0678852
UMLS CUI [3,2]
C1883010
UMLS CUI [4,1]
C0005953
UMLS CUI [4,2]
C0031843
UMLS CUI [4,3]
C1883010
at least 18 years old
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
both men and women must practice adequate contraception
Beskrivning

Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1]
C0700589
informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
restriction of some therapies/medications within specific timeframes prior to enrollment and during the study including prior therapy with pi3k, cytotoxic chemotherapy, biologic agents, nitrosoureas or mitomycin c, small-molecule kinase inhibitors, non-cytotoxic hormonal agents
Beskrivning

PI3K | Cytotoxic Chemotherapy | Biological Factors | Nitrosoureas | Mitomycin | Other Coding | Non-Cytotoxic Agent Hormonal

Datatyp

boolean

Alias
UMLS CUI [1]
C0044602
UMLS CUI [2]
C0677881
UMLS CUI [3]
C0005515
UMLS CUI [4]
C0028210
UMLS CUI [5]
C0002475
UMLS CUI [6]
C3846158
UMLS CUI [7,1]
C2827065
UMLS CUI [7,2]
C0458083
erlotinib intolerant
Beskrivning

Intolerance to erlotinib

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C1135135
taking oral corticosteroids chronically or > 1 mg/day warfarin
Beskrivning

Adrenal Cortex Hormones Oral chronic | Warfarin U/day

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C1527415
UMLS CUI [1,3]
C0205191
UMLS CUI [2,1]
C0043031
UMLS CUI [2,2]
C0456683
not recovered from the toxic effects of prior therapy
Beskrivning

Toxic effect Due to Prior Therapy | Recovery Lacking

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C1514463
UMLS CUI [2,1]
C2004454
UMLS CUI [2,2]
C0332268
history of diabetes mellitus and an hgba1c > 7%
Beskrivning

Diabetes Mellitus | Glucohemoglobin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2]
C0202054
uncontrolled intercurrent illness
Beskrivning

Comorbidity Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
pregnant or breastfeeding
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
congestive heart failure, unstable angina, or a myocardial infarction within 3 months of entering the study.
Beskrivning

Congestive heart failure | Angina, Unstable | Myocardial Infarction

Datatyp

boolean

Alias
UMLS CUI [1]
C0018802
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0027051
hiv positive
Beskrivning

HIV Seropositivity

Datatyp

boolean

Alias
UMLS CUI [1]
C0019699
diagnosis of another malignancy may exclude subject from study
Beskrivning

Cancer Other

Datatyp

boolean

Alias
UMLS CUI [1]
C1707251
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Similar models

Eligibility Cancer NCT00777699

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Cancer NCT00777699
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Diagnosis
Item
confirmed diagnosis of:
boolean
C0011900 (UMLS CUI [1])
Solid tumour Advanced Unresponsive to Treatment
Item
advanced solid tumor that is no longer responding to therapies or
boolean
C0280100 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0205269 (UMLS CUI [1,3])
Prior Therapy Non-Small Cell Lung Carcinoma Advanced | Prior Therapy Non-small cell lung cancer metastatic | erlotinib | gefitinib
Item
advanced or metastatic nsclc that has previously been treated with erlotinib or gefitinib
boolean
C1514463 (UMLS CUI [1,1])
C0007131 (UMLS CUI [1,2])
C0205179 (UMLS CUI [1,3])
C1514463 (UMLS CUI [2,1])
C0278987 (UMLS CUI [2,2])
C1135135 (UMLS CUI [3])
C1122962 (UMLS CUI [4])
ECOG performance status
Item
ecog performance status 0-1
boolean
C1520224 (UMLS CUI [1])
Organ function Hematologic | Bone Marrow function Hematologic | Organ function Serum Chemistry Measurement | Bone Marrow function Serum Chemistry Measurement
Item
adequate organ and bone arrow function as defined by hematological and serum chemistry limits
boolean
C0678852 (UMLS CUI [1,1])
C0205488 (UMLS CUI [1,2])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
C0205488 (UMLS CUI [2,3])
C0678852 (UMLS CUI [3,1])
C1883010 (UMLS CUI [3,2])
C0005953 (UMLS CUI [4,1])
C0031843 (UMLS CUI [4,2])
C1883010 (UMLS CUI [4,3])
Age
Item
at least 18 years old
boolean
C0001779 (UMLS CUI [1])
Contraceptive methods
Item
both men and women must practice adequate contraception
boolean
C0700589 (UMLS CUI [1])
Informed Consent
Item
informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
PI3K | Cytotoxic Chemotherapy | Biological Factors | Nitrosoureas | Mitomycin | Other Coding | Non-Cytotoxic Agent Hormonal
Item
restriction of some therapies/medications within specific timeframes prior to enrollment and during the study including prior therapy with pi3k, cytotoxic chemotherapy, biologic agents, nitrosoureas or mitomycin c, small-molecule kinase inhibitors, non-cytotoxic hormonal agents
boolean
C0044602 (UMLS CUI [1])
C0677881 (UMLS CUI [2])
C0005515 (UMLS CUI [3])
C0028210 (UMLS CUI [4])
C0002475 (UMLS CUI [5])
C3846158 (UMLS CUI [6])
C2827065 (UMLS CUI [7,1])
C0458083 (UMLS CUI [7,2])
Intolerance to erlotinib
Item
erlotinib intolerant
boolean
C1744706 (UMLS CUI [1,1])
C1135135 (UMLS CUI [1,2])
Adrenal Cortex Hormones Oral chronic | Warfarin U/day
Item
taking oral corticosteroids chronically or > 1 mg/day warfarin
boolean
C0001617 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
C0043031 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
Toxic effect Due to Prior Therapy | Recovery Lacking
Item
not recovered from the toxic effects of prior therapy
boolean
C0600688 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C1514463 (UMLS CUI [1,3])
C2004454 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
Diabetes Mellitus | Glucohemoglobin measurement
Item
history of diabetes mellitus and an hgba1c > 7%
boolean
C0011849 (UMLS CUI [1])
C0202054 (UMLS CUI [2])
Comorbidity Uncontrolled
Item
uncontrolled intercurrent illness
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Congestive heart failure | Angina, Unstable | Myocardial Infarction
Item
congestive heart failure, unstable angina, or a myocardial infarction within 3 months of entering the study.
boolean
C0018802 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
HIV Seropositivity
Item
hiv positive
boolean
C0019699 (UMLS CUI [1])
Cancer Other
Item
diagnosis of another malignancy may exclude subject from study
boolean
C1707251 (UMLS CUI [1])
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