ID

36665

Descripción

Phase II Single Arm Study of AZD9291 to Treat NSCLC Patients in Asia Pacific; ODM derived from: https://clinicaltrials.gov/show/NCT02442349

Link

https://clinicaltrials.gov/show/NCT02442349

Palabras clave

Versiones (1)
  1. 31/5/19 31/5/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

31 de mayo de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Non-Small Cell Lung Cancer NCT02442349

Inglés

Eligibility Non-Small Cell Lung Cancer NCT02442349

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
aged at least 18 years. patient from asia pacific will be enrolled only.
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
locally advanced or metastatic nsclc, not amenable to curative surgery or radiotherapy.
Descripción

Non-Small Cell Lung Carcinoma Advanced Locally | Non-small cell lung cancer metastatic | Disease Inappropriate Curative Surgery | Disease Inappropriate Therapeutic radiology procedure

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C1517927
UMLS CUI [2]
C0278987
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C1548788
UMLS CUI [3,3]
C1511562
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C1548788
UMLS CUI [4,3]
C1522449
radiological documentation of disease progression on the last treatment administered prior to enrolling in the study: following 1st line egfr tki treatment but who have not received further treatment or following prior therapy with an egfr tki and a platinum-based doublet chemotherapy. patients may have also received additional lines of treatment.
Descripción

Disease Progression Radiology | Status post First line treatment EGFR TKI | Chemotherapy Platinum-Based Double

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0242656
UMLS CUI [1,2]
C0043299
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C1708063
UMLS CUI [2,3]
C1443775
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C1514162
UMLS CUI [3,3]
C0205173
documented egfr mutation (at any time since the initial diagnosis of nsclc) known to be associated with egfr tki sensitivity (including g719x, exon 19 deletion, l858r, l861q).
Descripción

EGFR mutation | Sensitivity EGFR TKI | EGFR G719X | EGFR exon 19 deletion | EGFR L858R | EGFR L861Q

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3266992
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1443775
UMLS CUI [3]
C3830332
UMLS CUI [4]
C2736991
UMLS CUI [5]
C3274204
UMLS CUI [6]
C3274186
patients must have central confirmation of tumour t790m mutation positive status from a biopsy sample taken after confirmation of disease progression on the most recent treatment regimen.
Descripción

Tumor T790M Mutation Biopsy sample | Status post Disease Progression

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C3274192
UMLS CUI [1,3]
C0026882
UMLS CUI [1,4]
C0677862
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0242656
world health organisation (who) performance status 0-1 with no deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks.
Descripción

WHO performance status scale | Worsening Absent | Life Expectancy Minimum

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1298650
UMLS CUI [2,1]
C0332271
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0023671
UMLS CUI [3,2]
C1524031
at least one lesion, not previously irradiated and not chosen for biopsy during the study screening period, that can be accurately measured at baseline as ≥10mm in the longest diameter (except lymph nodes which must have short axis ≥15mm) with computerised tomography (ct) or magnetic resonance imaging (mri) which is suitable for accurate repeated measurements.
Descripción

Measurable lesion Quantity | Therapeutic radiology procedure Absent | Biopsy Absent | Measurable lesion Longest Diameter CT | Measurable lesion Longest Diameter MRI | Exception Lymph nodes Short axis

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0005558
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C1513041
UMLS CUI [4,2]
C0552406
UMLS CUI [4,3]
C0040405
UMLS CUI [5,1]
C1513041
UMLS CUI [5,2]
C0552406
UMLS CUI [5,3]
C0024485
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0024204
UMLS CUI [6,3]
C0522488
females of child-bearing potential using contraception and must have a negative pregnancy test.
Descripción

Childbearing Potential Contraceptive methods | Childbearing Potential Pregnancy test negative

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0427780
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
treatment with an egfr-tki (eg, erlotinib, gefitinib, icotinib or afatinib) within 8 days or approximately 5x half-life of study entry; any cytotoxic chemotherapy, investigational agents or other anticancer drugs within 14 days of study entry; previous treatment with azd9291 or a 3rd generation egfr tkis; major surgery within 4 weeks of study entry; radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of study entry; currently receiving treatment with potent inhibitors or inducers of cyp3a4.
Descripción

EGFR TKI | erlotinib | gefitinib | icotinib | Afatinib | Cytotoxic Chemotherapy | Investigational New Drugs | Antineoplastic Agents | AZD9291 | EGFR TKI Generation Third | Major surgery | Therapeutic radiology procedure Bone Marrow Percentage | Therapeutic radiology procedure Radiation Field Wide | CYP3A4 Inhibitors Strong | CYP3A4 Inducers Strong

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1443775
UMLS CUI [2]
C1135135
UMLS CUI [3]
C1122962
UMLS CUI [4]
C2604307
UMLS CUI [5]
C2987648
UMLS CUI [6]
C0677881
UMLS CUI [7]
C0013230
UMLS CUI [8]
C0003392
UMLS CUI [9]
C3896906
UMLS CUI [10,1]
C1443775
UMLS CUI [10,2]
C0079411
UMLS CUI [10,3]
C0205437
UMLS CUI [11]
C0679637
UMLS CUI [12,1]
C1522449
UMLS CUI [12,2]
C0005953
UMLS CUI [12,3]
C0439165
UMLS CUI [13,1]
C1522449
UMLS CUI [13,2]
C1882536
UMLS CUI [13,3]
C0332464
UMLS CUI [14,1]
C3850053
UMLS CUI [14,2]
C0442821
UMLS CUI [15,1]
C3850041
UMLS CUI [15,2]
C0442821
any unresolved toxicities from prior therapy.
Descripción

Toxicity Due to Prior Therapy | Resolution Lacking

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C1514463
UMLS CUI [2,1]
C1514893
UMLS CUI [2,2]
C0332268
unstable spinal cord compression or brain metastases.
Descripción

Compression of spinal cord Unstable | Metastatic malignant neoplasm to brain Unstable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0037926
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C0220650
UMLS CUI [2,2]
C0443343
severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses or infection.
Descripción

Systemic disease Severe | Systemic disease Uncontrolled | Uncontrolled hypertension | Bleeding tendency | Communicable Disease

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0442893
UMLS CUI [2,2]
C0205318
UMLS CUI [3]
C1868885
UMLS CUI [4]
C1458140
UMLS CUI [5]
C0009450
refractory nausea and vomiting, chronic gastrointestinal diseases or bowel resection.
Descripción

Intractable nausea and vomiting | Gastrointestinal Diseases chronic | Bowel resection

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3697880
UMLS CUI [2,1]
C0017178
UMLS CUI [2,2]
C0205191
UMLS CUI [3]
C0741614
cardiac disease.
Descripción

Heart Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0018799
past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.
Descripción

Lung Diseases, Interstitial | Drug-induced interstitial lung disorder | Radiation Pneumonitis Requirement Steroid therapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0206062
UMLS CUI [2]
C0348822
UMLS CUI [3,1]
C0206063
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C0149783
inadequate bone marrow reserve or organ function.
Descripción

Few mature neutrophils in the bone marrow | Organ function Inadequate

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2748959
UMLS CUI [2,1]
C0678852
UMLS CUI [2,2]
C0205412
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Similar models

Eligibility Non-Small Cell Lung Cancer NCT02442349

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
aged at least 18 years. patient from asia pacific will be enrolled only.
boolean
C0001779 (UMLS CUI [1])
Non-Small Cell Lung Carcinoma Advanced Locally | Non-small cell lung cancer metastatic | Disease Inappropriate Curative Surgery | Disease Inappropriate Therapeutic radiology procedure
Item
locally advanced or metastatic nsclc, not amenable to curative surgery or radiotherapy.
boolean
C0007131 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C1517927 (UMLS CUI [1,3])
C0278987 (UMLS CUI [2])
C0012634 (UMLS CUI [3,1])
C1548788 (UMLS CUI [3,2])
C1511562 (UMLS CUI [3,3])
C0012634 (UMLS CUI [4,1])
C1548788 (UMLS CUI [4,2])
C1522449 (UMLS CUI [4,3])
Disease Progression Radiology | Status post First line treatment EGFR TKI | Chemotherapy Platinum-Based Double
Item
radiological documentation of disease progression on the last treatment administered prior to enrolling in the study: following 1st line egfr tki treatment but who have not received further treatment or following prior therapy with an egfr tki and a platinum-based doublet chemotherapy. patients may have also received additional lines of treatment.
boolean
C0242656 (UMLS CUI [1,1])
C0043299 (UMLS CUI [1,2])
C0231290 (UMLS CUI [2,1])
C1708063 (UMLS CUI [2,2])
C1443775 (UMLS CUI [2,3])
C0392920 (UMLS CUI [3,1])
C1514162 (UMLS CUI [3,2])
C0205173 (UMLS CUI [3,3])
EGFR mutation | Sensitivity EGFR TKI | EGFR G719X | EGFR exon 19 deletion | EGFR L858R | EGFR L861Q
Item
documented egfr mutation (at any time since the initial diagnosis of nsclc) known to be associated with egfr tki sensitivity (including g719x, exon 19 deletion, l858r, l861q).
boolean
C3266992 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C1443775 (UMLS CUI [2,2])
C3830332 (UMLS CUI [3])
C2736991 (UMLS CUI [4])
C3274204 (UMLS CUI [5])
C3274186 (UMLS CUI [6])
Tumor T790M Mutation Biopsy sample | Status post Disease Progression
Item
patients must have central confirmation of tumour t790m mutation positive status from a biopsy sample taken after confirmation of disease progression on the most recent treatment regimen.
boolean
C0027651 (UMLS CUI [1,1])
C3274192 (UMLS CUI [1,2])
C0026882 (UMLS CUI [1,3])
C0677862 (UMLS CUI [1,4])
C0231290 (UMLS CUI [2,1])
C0242656 (UMLS CUI [2,2])
WHO performance status scale | Worsening Absent | Life Expectancy Minimum
Item
world health organisation (who) performance status 0-1 with no deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks.
boolean
C1298650 (UMLS CUI [1])
C0332271 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0023671 (UMLS CUI [3,1])
C1524031 (UMLS CUI [3,2])
Measurable lesion Quantity | Therapeutic radiology procedure Absent | Biopsy Absent | Measurable lesion Longest Diameter CT | Measurable lesion Longest Diameter MRI | Exception Lymph nodes Short axis
Item
at least one lesion, not previously irradiated and not chosen for biopsy during the study screening period, that can be accurately measured at baseline as ≥10mm in the longest diameter (except lymph nodes which must have short axis ≥15mm) with computerised tomography (ct) or magnetic resonance imaging (mri) which is suitable for accurate repeated measurements.
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0005558 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C1513041 (UMLS CUI [4,1])
C0552406 (UMLS CUI [4,2])
C0040405 (UMLS CUI [4,3])
C1513041 (UMLS CUI [5,1])
C0552406 (UMLS CUI [5,2])
C0024485 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0024204 (UMLS CUI [6,2])
C0522488 (UMLS CUI [6,3])
Childbearing Potential Contraceptive methods | Childbearing Potential Pregnancy test negative
Item
females of child-bearing potential using contraception and must have a negative pregnancy test.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0427780 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
EGFR TKI | erlotinib | gefitinib | icotinib | Afatinib | Cytotoxic Chemotherapy | Investigational New Drugs | Antineoplastic Agents | AZD9291 | EGFR TKI Generation Third | Major surgery | Therapeutic radiology procedure Bone Marrow Percentage | Therapeutic radiology procedure Radiation Field Wide | CYP3A4 Inhibitors Strong | CYP3A4 Inducers Strong
Item
treatment with an egfr-tki (eg, erlotinib, gefitinib, icotinib or afatinib) within 8 days or approximately 5x half-life of study entry; any cytotoxic chemotherapy, investigational agents or other anticancer drugs within 14 days of study entry; previous treatment with azd9291 or a 3rd generation egfr tkis; major surgery within 4 weeks of study entry; radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of study entry; currently receiving treatment with potent inhibitors or inducers of cyp3a4.
boolean
C1443775 (UMLS CUI [1])
C1135135 (UMLS CUI [2])
C1122962 (UMLS CUI [3])
C2604307 (UMLS CUI [4])
C2987648 (UMLS CUI [5])
C0677881 (UMLS CUI [6])
C0013230 (UMLS CUI [7])
C0003392 (UMLS CUI [8])
C3896906 (UMLS CUI [9])
C1443775 (UMLS CUI [10,1])
C0079411 (UMLS CUI [10,2])
C0205437 (UMLS CUI [10,3])
C0679637 (UMLS CUI [11])
C1522449 (UMLS CUI [12,1])
C0005953 (UMLS CUI [12,2])
C0439165 (UMLS CUI [12,3])
C1522449 (UMLS CUI [13,1])
C1882536 (UMLS CUI [13,2])
C0332464 (UMLS CUI [13,3])
C3850053 (UMLS CUI [14,1])
C0442821 (UMLS CUI [14,2])
C3850041 (UMLS CUI [15,1])
C0442821 (UMLS CUI [15,2])
Toxicity Due to Prior Therapy | Resolution Lacking
Item
any unresolved toxicities from prior therapy.
boolean
C0600688 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C1514463 (UMLS CUI [1,3])
C1514893 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
Compression of spinal cord Unstable | Metastatic malignant neoplasm to brain Unstable
Item
unstable spinal cord compression or brain metastases.
boolean
C0037926 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0220650 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
Systemic disease Severe | Systemic disease Uncontrolled | Uncontrolled hypertension | Bleeding tendency | Communicable Disease
Item
severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses or infection.
boolean
C0442893 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0442893 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C1868885 (UMLS CUI [3])
C1458140 (UMLS CUI [4])
C0009450 (UMLS CUI [5])
Intractable nausea and vomiting | Gastrointestinal Diseases chronic | Bowel resection
Item
refractory nausea and vomiting, chronic gastrointestinal diseases or bowel resection.
boolean
C3697880 (UMLS CUI [1])
C0017178 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0741614 (UMLS CUI [3])
Heart Disease
Item
cardiac disease.
boolean
C0018799 (UMLS CUI [1])
Lung Diseases, Interstitial | Drug-induced interstitial lung disorder | Radiation Pneumonitis Requirement Steroid therapy
Item
past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.
boolean
C0206062 (UMLS CUI [1])
C0348822 (UMLS CUI [2])
C0206063 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0149783 (UMLS CUI [3,3])
Few mature neutrophils in the bone marrow | Organ function Inadequate
Item
inadequate bone marrow reserve or organ function.
boolean
C2748959 (UMLS CUI [1])
C0678852 (UMLS CUI [2,1])
C0205412 (UMLS CUI [2,2])
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