ID

15680

Description

Pharmacokinetic and Safety Study of Lower Doses of Ceritinib Taken With a Low-fat Meal Versus 750 mg of Ceritinib in the Fasted State in Adult Patients With (ALK-positive) Metastatic Non-small Cell Lung Cancer (NSCLC); ODM derived from: https://clinicaltrials.gov/show/NCT02299505

Link

https://clinicaltrials.gov/show/NCT02299505

Keywords

Versions (1)
  1. 6/8/16 6/8/16 -
Uploaded on

June 8, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Non-Small Cell Lung Cancer. NCT02299505

English

Eligibility Non-Small Cell Lung Cancer. NCT02299505

1 forms  
Criteria
Description

Criteria

1. histologically or cytologically confirmed diagnosis of stage iiib (and is not a candidate for definitive multimodality therapy) or iv alk-positive nsclc.
Description

Non-Small Cell Lung Carcinoma | No indication of multimodality cancer therapy | Non-Small Cell Lung Carcinoma ALK gene rearrangement positive

Data type

boolean

Alias
UMLS CUI [1]
C0007131
UMLS CUI [2,1]
C0521090
UMLS CUI [2,2]
C0920596
UMLS CUI [3,1]
C0007131
UMLS CUI [3,2]
C3888914
2. all patients must have a tumor tissue sample available as an archival sample (collected either at the time of diagnosis of nsclc or any time since) or as a new biopsy to send to the novartis designated central laboratory.
Description

Tumor tissue sample Availability | Non-Small Cell Lung Carcinoma | Biopsy New

Data type

boolean

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C0470187
UMLS CUI [2]
C0007131
UMLS CUI [3,1]
C0005558
UMLS CUI [3,2]
C0205314
3. patients may have received one prior treatment regimen with crizotinib (all other alk inhibitors are excluded).
Description

Prior Therapy crizotinib | anaplastic lymphoma kinase inhibitors

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C2974289
UMLS CUI [2,1]
C0252409
UMLS CUI [2,2]
C0243077
4. patients may have received prior chemotherapy, biologic therapy, or other investigational agents. alk inhibitors other than crizotinib are excluded.
Description

Prior Chemotherapy | Biological Response Modifier Therapy | Investigational New Drugs | anaplastic lymphoma kinase inhibitors | crizotinib

Data type

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2]
C0005527
UMLS CUI [3]
C0013230
UMLS CUI [4,1]
C0252409
UMLS CUI [4,2]
C0243077
UMLS CUI [5]
C2974289
5. patient has a world health organization (who) performance status 0-2.
Description

WHO performance status scale

Data type

boolean

Alias
UMLS CUI [1]
C1298650
exclusion:
Description

Exclusion Criteria

Data type

boolean

Alias
UMLS CUI [1]
C0680251
1. prior treatment with an alk inhibitor other than crizotinib.
Description

Prior Therapy anaplastic lymphoma kinase inhibitors | crizotinib

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0252409
UMLS CUI [1,3]
C0243077
UMLS CUI [2]
C2974289
2. history of carcinomatous meningitis.
Description

Meningeal Carcinomatosis

Data type

boolean

Alias
UMLS CUI [1]
C0220654
3. presence or history of a malignant disease other than an alk-positive advanced tumor that has been diagnosed and/or required therapy within the past 3 years.
Description

Malignant Neoplasms | Malignant Neoplasms ALK gene rearrangement positive Advanced | Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C3888914
UMLS CUI [2,3]
C0205179
UMLS CUI [3]
C0087111
5. clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 months) 6. patient has history of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis (i.e., affecting activities of daily living or requiring therapeutic intervention).
Description

Heart Diseases Uncontrolled | cardiac event Recent | Lung Diseases, Interstitial | Pneumonia, Interstitial | Radiation Pneumonitis | Activities of Daily Living Affecting | Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0741923
UMLS CUI [2,2]
C0332185
UMLS CUI [3]
C0206062
UMLS CUI [4]
C0206061
UMLS CUI [5]
C0206063
UMLS CUI [6,1]
C0001288
UMLS CUI [6,2]
C0392760
UMLS CUI [7]
C0087111
7. patient has other severe, acute, or chronic medical conditions 8. patient is currently receiving treatment with warfarin sodium (coumadin®) or any other coumarin-derivative anticoagulants.
Description

medical condition Severe | medical condition acute | medical condition chronic | Therapeutic procedure Warfarin Sodium | Therapeutic procedure Coumadin | coumarin

Data type

boolean

Alias
UMLS CUI [1,1]
C1699700
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C1699700
UMLS CUI [2,2]
C0205178
UMLS CUI [3,1]
C1699700
UMLS CUI [3,2]
C0205191
UMLS CUI [4,1]
C0087111
UMLS CUI [4,2]
C0376218
UMLS CUI [5,1]
C0087111
UMLS CUI [5,2]
C0699129
UMLS CUI [6]
C0010206
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Similar models

Eligibility Non-Small Cell Lung Cancer. NCT02299505

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Non-Small Cell Lung Carcinoma | No indication of multimodality cancer therapy | Non-Small Cell Lung Carcinoma ALK gene rearrangement positive
Item
1. histologically or cytologically confirmed diagnosis of stage iiib (and is not a candidate for definitive multimodality therapy) or iv alk-positive nsclc.
boolean
C0007131 (UMLS CUI [1])
C0521090 (UMLS CUI [2,1])
C0920596 (UMLS CUI [2,2])
C0007131 (UMLS CUI [3,1])
C3888914 (UMLS CUI [3,2])
Tumor tissue sample Availability | Non-Small Cell Lung Carcinoma | Biopsy New
Item
2. all patients must have a tumor tissue sample available as an archival sample (collected either at the time of diagnosis of nsclc or any time since) or as a new biopsy to send to the novartis designated central laboratory.
boolean
C0475358 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C0007131 (UMLS CUI [2])
C0005558 (UMLS CUI [3,1])
C0205314 (UMLS CUI [3,2])
Prior Therapy crizotinib | anaplastic lymphoma kinase inhibitors
Item
3. patients may have received one prior treatment regimen with crizotinib (all other alk inhibitors are excluded).
boolean
C1514463 (UMLS CUI [1,1])
C2974289 (UMLS CUI [1,2])
C0252409 (UMLS CUI [2,1])
C0243077 (UMLS CUI [2,2])
Prior Chemotherapy | Biological Response Modifier Therapy | Investigational New Drugs | anaplastic lymphoma kinase inhibitors | crizotinib
Item
4. patients may have received prior chemotherapy, biologic therapy, or other investigational agents. alk inhibitors other than crizotinib are excluded.
boolean
C1514457 (UMLS CUI [1])
C0005527 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
C0252409 (UMLS CUI [4,1])
C0243077 (UMLS CUI [4,2])
C2974289 (UMLS CUI [5])
WHO performance status scale
Item
5. patient has a world health organization (who) performance status 0-2.
boolean
C1298650 (UMLS CUI [1])
Exclusion Criteria
Item
exclusion:
boolean
C0680251 (UMLS CUI [1])
Prior Therapy anaplastic lymphoma kinase inhibitors | crizotinib
Item
1. prior treatment with an alk inhibitor other than crizotinib.
boolean
C1514463 (UMLS CUI [1,1])
C0252409 (UMLS CUI [1,2])
C0243077 (UMLS CUI [1,3])
C2974289 (UMLS CUI [2])
Meningeal Carcinomatosis
Item
2. history of carcinomatous meningitis.
boolean
C0220654 (UMLS CUI [1])
Malignant Neoplasms | Malignant Neoplasms ALK gene rearrangement positive Advanced | Therapeutic procedure
Item
3. presence or history of a malignant disease other than an alk-positive advanced tumor that has been diagnosed and/or required therapy within the past 3 years.
boolean
C0006826 (UMLS CUI [1])
C0006826 (UMLS CUI [2,1])
C3888914 (UMLS CUI [2,2])
C0205179 (UMLS CUI [2,3])
C0087111 (UMLS CUI [3])
Heart Diseases Uncontrolled | cardiac event Recent | Lung Diseases, Interstitial | Pneumonia, Interstitial | Radiation Pneumonitis | Activities of Daily Living Affecting | Therapeutic procedure
Item
5. clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 months) 6. patient has history of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis (i.e., affecting activities of daily living or requiring therapeutic intervention).
boolean
C0018799 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0741923 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
C0206062 (UMLS CUI [3])
C0206061 (UMLS CUI [4])
C0206063 (UMLS CUI [5])
C0001288 (UMLS CUI [6,1])
C0392760 (UMLS CUI [6,2])
C0087111 (UMLS CUI [7])
medical condition Severe | medical condition acute | medical condition chronic | Therapeutic procedure Warfarin Sodium | Therapeutic procedure Coumadin | coumarin
Item
7. patient has other severe, acute, or chronic medical conditions 8. patient is currently receiving treatment with warfarin sodium (coumadin®) or any other coumarin-derivative anticoagulants.
boolean
C1699700 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1699700 (UMLS CUI [2,1])
C0205178 (UMLS CUI [2,2])
C1699700 (UMLS CUI [3,1])
C0205191 (UMLS CUI [3,2])
C0087111 (UMLS CUI [4,1])
C0376218 (UMLS CUI [4,2])
C0087111 (UMLS CUI [5,1])
C0699129 (UMLS CUI [5,2])
C0010206 (UMLS CUI [6])
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