ID

15680

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT02299505

Nyckelord

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

8 juni 2016

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Non-Small Cell Lung Cancer. NCT02299505

Engelsk

Eligibility Non-Small Cell Lung Cancer. NCT02299505

1 Formulär  
Criteria
Beskrivning

Criteria

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

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

Datatyp

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.
Beskrivning

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

Datatyp

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).
Beskrivning

Prior Therapy crizotinib | anaplastic lymphoma kinase inhibitors

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

WHO performance status scale

Datatyp

boolean

Alias
UMLS CUI [1]
C1298650
exclusion:
Beskrivning

Exclusion Criteria

Datatyp

boolean

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

Prior Therapy anaplastic lymphoma kinase inhibitors | crizotinib

Datatyp

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.
Beskrivning

Meningeal Carcinomatosis

Datatyp

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.
Beskrivning

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

Datatyp

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).
Beskrivning

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

Datatyp

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.
Beskrivning

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

Datatyp

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
Tillbaka till toppen

Similar models

Eligibility Non-Small Cell Lung Cancer. NCT02299505

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial