ID

15677

Beskrivning

Study of Safety and Efficacy of LEE011 and Ceritinib in Patients With ALK-positive Non-small Cell Lung Cancer.; ODM derived from: https://clinicaltrials.gov/show/NCT02292550

Länk

https://clinicaltrials.gov/show/NCT02292550

Nyckelord

Versioner (1)
  1. 2016-06-08 2016-06-08 -
Uppladdad den

8 juni 2016

DOI

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Creative Commons BY 4.0
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Eligibility Non-small Cell Lung Cancer NCT02292550

Engelsk

Eligibility Non-small Cell Lung Cancer NCT02292550

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must be diagnosed with alk-positive advanced nsclc. the tumor must be alk-positive as determined by alk rearrangement in ≥15% of cells (as measured by fish using the vysis break-apart alk probe) or by using the ventana alk ihc test. the analysis may be performed locally.
Beskrivning

Non-Small Cell Lung Carcinoma Advanced ALK gene rearrangement positive

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C3888914
eastern cooperative oncology group (ecog) performance status ≤ 2.
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
measurable disease as per recist v1.1
Beskrivning

Measurable Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C1513041
availability of tumor sample:
Beskrivning

Tumor tissue sample Availability

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C0470187
for alk inhibitor naïve patients:
Beskrivning

Anaplastic lymphoma kinase Inhibitor | Therapy naive

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0252409
UMLS CUI [1,2]
C1999216
UMLS CUI [2]
C0919936
o a representative tumor sample must be submitted. an archival tumor specimen is acceptable
Beskrivning

Tumor tissue sample Representative

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C1882932
for patients after progression on an alk inhibitor:
Beskrivning

anaplastic lymphoma kinase Inhibitor | Disease Progression

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0252409
UMLS CUI [1,2]
C1999216
UMLS CUI [2]
C0242656
o a new tumor biopsy is required unless a biopsy performed after progression on the patient's most recent alk inhibitor is available for submission for all patients a newly obtained tumor specimen must be submitted if no appropriate archival sample is available. in the event that no sample is available and a new biopsy cannot be obtained, enrollment may be considered after discussion with the sponsor.
Beskrivning

Malignant Neoplasms Biopsy New | Tumor tissue sample New

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0005558
UMLS CUI [1,3]
C0205314
UMLS CUI [2,1]
C0475358
UMLS CUI [2,2]
C0205314
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
for phase ii part:
Beskrivning

Phase 2 Clinical Trial

Datatyp

boolean

Alias
UMLS CUI [1]
C0282460
group a: prior therapy with any alk inhibitor is not permitted.
Beskrivning

Group A | anaplastic lymphoma kinase Inhibitor | Prior Therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0441835
UMLS CUI [2,1]
C0252409
UMLS CUI [2,2]
C1999216
UMLS CUI [3]
C1514463
group b: progression following any alk inhibitor(s) other than ceritinib is required and the last dose of the alk inhibitor must be no more than 60 days prior to the first dose of study drug. prior ceritinib is not permitted.
Beskrivning

Group B | Disease Progression | anaplastic lymphoma kinase Inhibitor | ceritinib

Datatyp

boolean

Alias
UMLS CUI [1]
C0441836
UMLS CUI [2]
C0242656
UMLS CUI [3,1]
C0252409
UMLS CUI [3,2]
C1999216
UMLS CUI [4]
C3818721
group c: progression following ceritinib is required and the last dose of ceritinib must be no more than 60 days prior to the first dose of study drug.
Beskrivning

Group C | ceritinib | Disease Progression

Datatyp

boolean

Alias
UMLS CUI [1]
C0441837
UMLS CUI [2]
C3818721
UMLS CUI [3]
C0242656
patients who have previously received ceritinib must have tolerated a dose of ceritinib 600 mg qd, or greater.
Beskrivning

ceritinib Previous | ceritinib Dosage

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3818721
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C3818721
UMLS CUI [2,2]
C0178602
patients with symptomatic central nervous system (cns) metastases who are neurologically unstable or require increasing doses of steroids or local cns-directed therapy to control their cns disease
Beskrivning

CNS metastases Symptomatic Neurologic Unstable status | Steroids | Therapeutic procedure Central Nervous System

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0231220
UMLS CUI [1,3]
C0205494
UMLS CUI [1,4]
C0443343
UMLS CUI [2]
C0038317
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C3714787
impaired cardiac function or any clinically significant cardiac disease
Beskrivning

Decreased cardiac function | Heart Diseases

Datatyp

boolean

Alias
UMLS CUI [1]
C0232166
UMLS CUI [2]
C0018799
patients with abnormal laboratory values during screening and on day 1 of pre-dose
Beskrivning

Laboratory test result abnormal

Datatyp

boolean

Alias
UMLS CUI [1]
C0438215
impairment of gastrointestinal (gi) function or gi disease that may significantly alter the absorption of ceritinib or lee011
Beskrivning

gastrointestinal function Impaired | Gastrointestinal Diseases Affecting Absorption ceritinib | Gastrointestinal Diseases Affecting Absorption LEE011

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0516983
UMLS CUI [1,2]
C0221099
UMLS CUI [2,1]
C0017178
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0021826
UMLS CUI [2,4]
C3818721
UMLS CUI [3,1]
C0017178
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C0021826
UMLS CUI [3,4]
C2987342
patients who are currently receiving treatment (that cannot be discontinued at least 1 week prior to the initiation of the study) with agents that are known to be any of the following: strong inducers or inhibitors of cyp3a4/5; sensitive substrates of cyp3a; substrates of cyp3a4/5 or cyp2c9 with a narrow therapeutic index.
Beskrivning

Therapeutic procedure | Cytochrome P450 3A4 Inducer | Cytochrome P450 3A4 Inhibitor | Cytochrome P-450 CYP3A5 Inducers | Cytochrome P-450 CYP3A5 Inhibitors | cytochrome P450 3A Substrate Sensitive | Cytochrome P-450 CYP3A4 Substrate Narrow Therapeutic Index | Cytochrome P-450 CYP3A5 Substrate Narrow Therapeutic Index | Cytochrome p450 CYP2 enzyme Substrate Narrow Therapeutic Index

Datatyp

boolean

Alias
UMLS CUI [1]
C0087111
UMLS CUI [2]
C3830625
UMLS CUI [3]
C3830624
UMLS CUI [4]
C3850043
UMLS CUI [5]
C3850054
UMLS CUI [6,1]
C0059563
UMLS CUI [6,2]
C3891814
UMLS CUI [6,3]
C0332324
UMLS CUI [7,1]
C3714798
UMLS CUI [7,2]
C3891814
UMLS CUI [7,3]
C3889681
UMLS CUI [8,1]
C3714750
UMLS CUI [8,2]
C3891814
UMLS CUI [8,3]
C3889681
UMLS CUI [9,1]
C1828473
UMLS CUI [9,2]
C3891814
UMLS CUI [9,3]
C3889681
patient has a history of pancreatitis or history of increased amylase or lipase that was due to pancreatic disease.
Beskrivning

Pancreatitis | Amylase increased | Lipase Due to Pancreatic Diseases

Datatyp

boolean

Alias
UMLS CUI [1]
C0030305
UMLS CUI [2]
C0151479
UMLS CUI [3,1]
C0023764
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0030286
other protocol-defined inclusion/exclusion criteria may apply.
Beskrivning

Inclusion Other | Exclusion Criteria Other

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0205394
UMLS CUI [2,1]
C0680251
UMLS CUI [2,2]
C0205394
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Similar models

Eligibility Non-small Cell Lung Cancer NCT02292550

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma Advanced ALK gene rearrangement positive
Item
patients must be diagnosed with alk-positive advanced nsclc. the tumor must be alk-positive as determined by alk rearrangement in ≥15% of cells (as measured by fish using the vysis break-apart alk probe) or by using the ventana alk ihc test. the analysis may be performed locally.
boolean
C0007131 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C3888914 (UMLS CUI [1,3])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status ≤ 2.
boolean
C1520224 (UMLS CUI [1])
Measurable Disease
Item
measurable disease as per recist v1.1
boolean
C1513041 (UMLS CUI [1])
Tumor tissue sample Availability
Item
availability of tumor sample:
boolean
C0475358 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
Anaplastic lymphoma kinase Inhibitor | Therapy naive
Item
for alk inhibitor naïve patients:
boolean
C0252409 (UMLS CUI [1,1])
C1999216 (UMLS CUI [1,2])
C0919936 (UMLS CUI [2])
Tumor tissue sample Representative
Item
o a representative tumor sample must be submitted. an archival tumor specimen is acceptable
boolean
C0475358 (UMLS CUI [1,1])
C1882932 (UMLS CUI [1,2])
anaplastic lymphoma kinase Inhibitor | Disease Progression
Item
for patients after progression on an alk inhibitor:
boolean
C0252409 (UMLS CUI [1,1])
C1999216 (UMLS CUI [1,2])
C0242656 (UMLS CUI [2])
Malignant Neoplasms Biopsy New | Tumor tissue sample New
Item
o a new tumor biopsy is required unless a biopsy performed after progression on the patient's most recent alk inhibitor is available for submission for all patients a newly obtained tumor specimen must be submitted if no appropriate archival sample is available. in the event that no sample is available and a new biopsy cannot be obtained, enrollment may be considered after discussion with the sponsor.
boolean
C0006826 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C0205314 (UMLS CUI [1,3])
C0475358 (UMLS CUI [2,1])
C0205314 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Phase 2 Clinical Trial
Item
for phase ii part:
boolean
C0282460 (UMLS CUI [1])
Group A | anaplastic lymphoma kinase Inhibitor | Prior Therapy
Item
group a: prior therapy with any alk inhibitor is not permitted.
boolean
C0441835 (UMLS CUI [1])
C0252409 (UMLS CUI [2,1])
C1999216 (UMLS CUI [2,2])
C1514463 (UMLS CUI [3])
Group B | Disease Progression | anaplastic lymphoma kinase Inhibitor | ceritinib
Item
group b: progression following any alk inhibitor(s) other than ceritinib is required and the last dose of the alk inhibitor must be no more than 60 days prior to the first dose of study drug. prior ceritinib is not permitted.
boolean
C0441836 (UMLS CUI [1])
C0242656 (UMLS CUI [2])
C0252409 (UMLS CUI [3,1])
C1999216 (UMLS CUI [3,2])
C3818721 (UMLS CUI [4])
Group C | ceritinib | Disease Progression
Item
group c: progression following ceritinib is required and the last dose of ceritinib must be no more than 60 days prior to the first dose of study drug.
boolean
C0441837 (UMLS CUI [1])
C3818721 (UMLS CUI [2])
C0242656 (UMLS CUI [3])
ceritinib Previous | ceritinib Dosage
Item
patients who have previously received ceritinib must have tolerated a dose of ceritinib 600 mg qd, or greater.
boolean
C3818721 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C3818721 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
CNS metastases Symptomatic Neurologic Unstable status | Steroids | Therapeutic procedure Central Nervous System
Item
patients with symptomatic central nervous system (cns) metastases who are neurologically unstable or require increasing doses of steroids or local cns-directed therapy to control their cns disease
boolean
C0686377 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0205494 (UMLS CUI [1,3])
C0443343 (UMLS CUI [1,4])
C0038317 (UMLS CUI [2])
C0087111 (UMLS CUI [3,1])
C3714787 (UMLS CUI [3,2])
Decreased cardiac function | Heart Diseases
Item
impaired cardiac function or any clinically significant cardiac disease
boolean
C0232166 (UMLS CUI [1])
C0018799 (UMLS CUI [2])
Laboratory test result abnormal
Item
patients with abnormal laboratory values during screening and on day 1 of pre-dose
boolean
C0438215 (UMLS CUI [1])
gastrointestinal function Impaired | Gastrointestinal Diseases Affecting Absorption ceritinib | Gastrointestinal Diseases Affecting Absorption LEE011
Item
impairment of gastrointestinal (gi) function or gi disease that may significantly alter the absorption of ceritinib or lee011
boolean
C0516983 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
C0017178 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0021826 (UMLS CUI [2,3])
C3818721 (UMLS CUI [2,4])
C0017178 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0021826 (UMLS CUI [3,3])
C2987342 (UMLS CUI [3,4])
Therapeutic procedure | Cytochrome P450 3A4 Inducer | Cytochrome P450 3A4 Inhibitor | Cytochrome P-450 CYP3A5 Inducers | Cytochrome P-450 CYP3A5 Inhibitors | cytochrome P450 3A Substrate Sensitive | Cytochrome P-450 CYP3A4 Substrate Narrow Therapeutic Index | Cytochrome P-450 CYP3A5 Substrate Narrow Therapeutic Index | Cytochrome p450 CYP2 enzyme Substrate Narrow Therapeutic Index
Item
patients who are currently receiving treatment (that cannot be discontinued at least 1 week prior to the initiation of the study) with agents that are known to be any of the following: strong inducers or inhibitors of cyp3a4/5; sensitive substrates of cyp3a; substrates of cyp3a4/5 or cyp2c9 with a narrow therapeutic index.
boolean
C0087111 (UMLS CUI [1])
C3830625 (UMLS CUI [2])
C3830624 (UMLS CUI [3])
C3850043 (UMLS CUI [4])
C3850054 (UMLS CUI [5])
C0059563 (UMLS CUI [6,1])
C3891814 (UMLS CUI [6,2])
C0332324 (UMLS CUI [6,3])
C3714798 (UMLS CUI [7,1])
C3891814 (UMLS CUI [7,2])
C3889681 (UMLS CUI [7,3])
C3714750 (UMLS CUI [8,1])
C3891814 (UMLS CUI [8,2])
C3889681 (UMLS CUI [8,3])
C1828473 (UMLS CUI [9,1])
C3891814 (UMLS CUI [9,2])
C3889681 (UMLS CUI [9,3])
Pancreatitis | Amylase increased | Lipase Due to Pancreatic Diseases
Item
patient has a history of pancreatitis or history of increased amylase or lipase that was due to pancreatic disease.
boolean
C0030305 (UMLS CUI [1])
C0151479 (UMLS CUI [2])
C0023764 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0030286 (UMLS CUI [3,3])
Inclusion Other | Exclusion Criteria Other
Item
other protocol-defined inclusion/exclusion criteria may apply.
boolean
C1512693 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0680251 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
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