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])
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])