ID

14032

Description

A Study Of PF-06463922 An ALK/ROS1 Inhibitor In Patients With Advanced Non Small Cell Lung Cancer With Specific Molecular Alterations; ODM derived from: https://clinicaltrials.gov/show/NCT01970865

Link

https://clinicaltrials.gov/show/NCT01970865

Keywords

Versions (1)
  1. 3/22/16 3/22/16 -
Uploaded on

March 22, 2016

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility ALK Positive Non Small Cell Lung Cancer NCT01970865

English

Eligibility ALK Positive Non Small Cell Lung Cancer NCT01970865

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
evidence of histologically or cytologically confirmed diagnosis of locally advanced or metastatic nsclc (stage iv, ajcc v7.0) that carries an alk rearrangement, as determined by the food and drug administration (fda) approved fish assay (abbott molecular inc) or by immunohistochemistry (ihc) (ventana inc), or a ros1 rearrangement as determined by fish or rt pcr or next generation sequencing (ngs) via a local diagnostic test (ldt).
Description

nsclc

Data type

boolean

Alias
UMLS CUI [1]
C0278987
alk+ nsclc patients must either be treatment naïve in the advanced setting or have had disease progression after 1or 2 previous alk inhibitor therapy(ies), as the last therapy given (phase 1 allows for intervening chemotherapy and more than 2 prior alk inhibitors).
Description

treatment naïve

Data type

boolean

Alias
UMLS CUI [1]
C3640935
ros1+ nsclc patients must either be treatment naïve in the advanced setting or have had disease progression after 1or 2 previous ros1 inhibitor therapy(ies), as the last therapy given (phase 1 allows for intervening chemotherapy and more than 2 prior ros inhibitors).
Description

ros1 inhibitor

Data type

boolean

Alias
UMLS CUI [1,1]
C0812281
UMLS CUI [1,2]
C1999216
archival tissue sample available collected prior to enrollment.
Description

Tissue specimen

Data type

boolean

Alias
UMLS CUI [1]
C1292533
all patients must have at least one measurable target extracranial lesion according to recist v1.1. in addition patients with asymptomatic cns metastases (including patients asymptomatic by means of stable or decreasing doses of steroids within the last 2 weeks prior to study entry) are eligible.
Description

extracranial lesion

Data type

boolean

Alias
UMLS CUI [1]
C0580586
adequate bone marrow, pancreatic, renal, liver function.
Description

adequate bone marrow, pancreatic, renal, liver function.

Data type

boolean

Alias
UMLS CUI [1]
C0005953
UMLS CUI [2]
C0232786
UMLS CUI [3]
C0232804
pregnancy test (for females of childbearing potential) negative at screening and at the baseline visit . male and female patients of childbearing potential must agree to use two highly effective methods of contraception from the time of the first negative pregnancy test at screening, throughout the study and for 90 days after the last dose of assigned treatment.
Description

Pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1]
C0427780
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
radiation therapy (except palliative to relieve bone pain) within 2 weeks of study entry. stereotactic or small field brain irradiation must have completed at least 2 weeks prior to study entry. whole brain radiation must have completed at least 4 weeks prior to study entry.
Description

radiation therapy

Data type

boolean

Alias
UMLS CUI [1]
C1522449
systemic anticancer therapy completed within a minimum of 5 half-lives of study entry.
Description

anticancer therapy

Data type

boolean

Alias
UMLS CUI [1]
C0920425
any one of the following currently or in the previous 3 months: myocardial infarction, congenital long qt syndrome, torsades de pointes, arrhythmias (including sustained ventricular tachyarrhythmia and ventricular fibrillation), right bundle branch block and left anterior hemiblock (bifascicular block), unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (chf ny heart association class iii or iv), cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism not adequately medically managed with anticoagulants; as well as bradycardia defined as <50 bpms. ongoing cardiac dysrhythmias of nci ctcae grade ≥ 2, symptomatic atrial fibrillation of any grade, or qtc interval >=481 msec at screening. right bundle branch block.
Description

Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C1141890
history of extensive, disseminated, bilateral or presence of grade 3 or 4 interstitial fibrosis or interstitial lung disease.
Description

Interstitial Lung Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0206062
current use or anticipated need for food or drugs that are known strong or moderate cyp3a4 inhibitors, inducers and cyp3a4 substrates with narrow therapeutic indices.
Description

cyp3a4 affecting substrates

Data type

boolean

Alias
UMLS CUI [1]
C1142644
concurrent use of drugs that are cyp2c9 substrates with narrow therapeutic indices or those that are sensitive cyp2b6 substrates.
Description

Cytochrome p450 CYP2 enzyme

Data type

boolean

Alias
UMLS CUI [1]
C1828473
Back to the top of the page

Similar models

Eligibility ALK Positive Non Small Cell Lung Cancer NCT01970865

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
nsclc
Item
evidence of histologically or cytologically confirmed diagnosis of locally advanced or metastatic nsclc (stage iv, ajcc v7.0) that carries an alk rearrangement, as determined by the food and drug administration (fda) approved fish assay (abbott molecular inc) or by immunohistochemistry (ihc) (ventana inc), or a ros1 rearrangement as determined by fish or rt pcr or next generation sequencing (ngs) via a local diagnostic test (ldt).
boolean
C0278987 (UMLS CUI [1])
treatment naïve
Item
alk+ nsclc patients must either be treatment naïve in the advanced setting or have had disease progression after 1or 2 previous alk inhibitor therapy(ies), as the last therapy given (phase 1 allows for intervening chemotherapy and more than 2 prior alk inhibitors).
boolean
C3640935 (UMLS CUI [1])
ros1 inhibitor
Item
ros1+ nsclc patients must either be treatment naïve in the advanced setting or have had disease progression after 1or 2 previous ros1 inhibitor therapy(ies), as the last therapy given (phase 1 allows for intervening chemotherapy and more than 2 prior ros inhibitors).
boolean
C0812281 (UMLS CUI [1,1])
C1999216 (UMLS CUI [1,2])
Tissue specimen
Item
archival tissue sample available collected prior to enrollment.
boolean
C1292533 (UMLS CUI [1])
extracranial lesion
Item
all patients must have at least one measurable target extracranial lesion according to recist v1.1. in addition patients with asymptomatic cns metastases (including patients asymptomatic by means of stable or decreasing doses of steroids within the last 2 weeks prior to study entry) are eligible.
boolean
C0580586 (UMLS CUI [1])
adequate bone marrow, pancreatic, renal, liver function.
Item
adequate bone marrow, pancreatic, renal, liver function.
boolean
C0005953 (UMLS CUI [1])
C0232786 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Pregnancy test negative
Item
pregnancy test (for females of childbearing potential) negative at screening and at the baseline visit . male and female patients of childbearing potential must agree to use two highly effective methods of contraception from the time of the first negative pregnancy test at screening, throughout the study and for 90 days after the last dose of assigned treatment.
boolean
C0427780 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
radiation therapy
Item
radiation therapy (except palliative to relieve bone pain) within 2 weeks of study entry. stereotactic or small field brain irradiation must have completed at least 2 weeks prior to study entry. whole brain radiation must have completed at least 4 weeks prior to study entry.
boolean
C1522449 (UMLS CUI [1])
anticancer therapy
Item
systemic anticancer therapy completed within a minimum of 5 half-lives of study entry.
boolean
C0920425 (UMLS CUI [1])
Myocardial Infarction
Item
any one of the following currently or in the previous 3 months: myocardial infarction, congenital long qt syndrome, torsades de pointes, arrhythmias (including sustained ventricular tachyarrhythmia and ventricular fibrillation), right bundle branch block and left anterior hemiblock (bifascicular block), unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (chf ny heart association class iii or iv), cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism not adequately medically managed with anticoagulants; as well as bradycardia defined as <50 bpms. ongoing cardiac dysrhythmias of nci ctcae grade ≥ 2, symptomatic atrial fibrillation of any grade, or qtc interval >=481 msec at screening. right bundle branch block.
boolean
C0027051 (UMLS CUI [1])
C1141890 (UMLS CUI [2])
Interstitial Lung Diseases
Item
history of extensive, disseminated, bilateral or presence of grade 3 or 4 interstitial fibrosis or interstitial lung disease.
boolean
C0206062 (UMLS CUI [1])
cyp3a4 affecting substrates
Item
current use or anticipated need for food or drugs that are known strong or moderate cyp3a4 inhibitors, inducers and cyp3a4 substrates with narrow therapeutic indices.
boolean
C1142644 (UMLS CUI [1])
Cytochrome p450 CYP2 enzyme
Item
concurrent use of drugs that are cyp2c9 substrates with narrow therapeutic indices or those that are sensitive cyp2b6 substrates.
boolean
C1828473 (UMLS CUI [1])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

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