ID

27493

Descrição

Trial of Continuous Once Daily Oral Treatment Using BIBW 2992 (Afatinib) Plus Sirolimus (Rapamune®) in Patients With Non-small Cell Lung Cancer Harbouring an EGFR Mutation and/or Disease Progression Following Prior Erlotinib or Gefitinib; ODM derived from: https://clinicaltrials.gov/show/NCT00993499

Link

https://clinicaltrials.gov/show/NCT00993499

Palavras-chave

Versões (1)
  1. 17/11/2017 17/11/2017 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

17 de novembro de 2017

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Carcinoma, Non-Small-Cell Lung NCT00993499

Inglês

Eligibility Carcinoma, Non-Small-Cell Lung NCT00993499

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. pathologically or cytologically confirmed diagnosis of stage iiib or stage iv nsclc
Descrição

Non-Small Cell Lung Carcinoma TNM clinical staging

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
2. patients who have failed conventional treatment (at least 1 prior treatment line), or for whom no therapy of proven efficacy exists
Descrição

Conventional Treatment Quantity failed | Therapeutic procedure Effective Lacking

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2945704
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0231175
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1280519
UMLS CUI [2,3]
C0332268
3. patients whose tumors:
Descrição

Malignant Neoplasms

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0006826
are egfr mutation-positive or
Descrição

EGFR gene mutation Positive

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3266992
UMLS CUI [1,2]
C1514241
are egfr mutation-negative or unknown provided they had disease progression after achieving either response or stable disease for at least 6 months from a previous treatment with erlotinib (tarceva®) or gefitinib (iressa®)
Descrição

EGFR gene mutation Negative | EGFR gene mutation Unknown | Disease Progression | erlotinib | Tarceva | gefitinib | Iressa | Disease Response | Stable Disease

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3266992
UMLS CUI [1,2]
C1513916
UMLS CUI [2,1]
C3266992
UMLS CUI [2,2]
C0439673
UMLS CUI [3]
C0242656
UMLS CUI [4]
C1135135
UMLS CUI [5]
C1135136
UMLS CUI [6]
C1122962
UMLS CUI [7]
C0919281
UMLS CUI [8]
C1704632
UMLS CUI [9]
C0677946
4. patients aged 18 years or older
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
5. life expectancy of at least three (3) months
Descrição

Life Expectancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023671
6. eastern cooperative oncology group (ecog, r01-0787) performance score 0-2
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
7. written informed consent that is consistent with ich-gcp guidelines
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. prior major surgery, chemotherapy or radiation therapy within 4 weeks before start of therapy.
Descrição

Major surgery | Chemotherapy | Therapeutic radiology procedure

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2]
C0392920
UMLS CUI [3]
C1522449
2. prior treatment with an mtor inhibitor within the past 4 weeks before start of therapy or concomitantly with this study
Descrição

mTOR Inhibitor

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2746052
3. use of erlotinib (tarceva®) or gefitinib (iressa®) within 14 days of run-in treatment with sirolimus
Descrição

erlotinib | Tarceva | gefitinib | Iressa | Sirolimus

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1135135
UMLS CUI [2]
C1135136
UMLS CUI [3]
C1122962
UMLS CUI [4]
C0919281
UMLS CUI [5]
C0072980
4. active cns metastases (defined as stable for <4 weeks and/or symptomatic and/or requiring treatment with anticonvulsants or steroids)
Descrição

CNS metastases Stable | CNS metastases Symptomatic | CNS metastases Requirement Anticonvulsants | CNS metastases Requirement Steroids

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0205360
UMLS CUI [2,1]
C0686377
UMLS CUI [2,2]
C0231220
UMLS CUI [3,1]
C0686377
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C0003286
UMLS CUI [4,1]
C0686377
UMLS CUI [4,2]
C1514873
UMLS CUI [4,3]
C0038317
5. severe alteration in serum fasting cholesterol (equal or more than 350 mg/dl) or triglycerides (equal or more than 400 mg/dl). patients may be allowed to enrol on the trial after initiation of lipid lowering agents.
Descrição

Fasting cholesterol level Alteration Severe | Triglycerides measurement Alteration Severe | Enrollment allowed Post Initiation Hypolipidemic Agents

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1282513
UMLS CUI [1,2]
C1515926
UMLS CUI [1,3]
C0205082
UMLS CUI [2,1]
C0202236
UMLS CUI [2,2]
C1515926
UMLS CUI [2,3]
C0205082
UMLS CUI [3,1]
C1516879
UMLS CUI [3,2]
C0683607
UMLS CUI [3,3]
C0687676
UMLS CUI [3,4]
C1704686
UMLS CUI [3,5]
C0086440
6. requirement for treatment with any of the prohibited concomitant medications:
Descrição

Illicit drug use

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0281875
concomitant cyp3a4 inhibitors within the past 7 days before start of therapy or concomitantly with this study.
Descrição

CYP3A4 Inhibitors

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3850053
concomitant cyp3a4 inducers within the past 14 days before start of therapy or concomitantly with this study.
Descrição

CYP3A4 Inducers

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3850041
7. any contraindications for therapy with sirolimus.
Descrição

Medical contraindication Sirolimus

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0072980
8. known hypersensitivity to bibw 2992, sirolimus or other rapamycin analogues (everolimus, temsirolimus, deforolimus, etc.) or the excipients of any of the trial drugs.
Descrição

Hypersensitivity BIBW 2992 | Hypersensitivity Sirolimus | Hypersensitivity Rapamycin Analogue | Hypersensitivity everolimus | Hypersensitivity temsirolimus | Hypersensitivity deforolimus | Hypersensitivity Investigational New Drugs Excipient

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C4083270
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0072980
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0072980
UMLS CUI [3,3]
C0243071
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0541315
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C1707080
UMLS CUI [6,1]
C0020517
UMLS CUI [6,2]
C2713007
UMLS CUI [7,1]
C0020517
UMLS CUI [7,2]
C0013230
UMLS CUI [7,3]
C0015237
9. use of any investigational drug within 4 weeks before start of therapy.
Descrição

Investigational New Drugs

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0013230
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Similar models

Eligibility Carcinoma, Non-Small-Cell Lung NCT00993499

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma TNM clinical staging
Item
1. pathologically or cytologically confirmed diagnosis of stage iiib or stage iv nsclc
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Conventional Treatment Quantity failed | Therapeutic procedure Effective Lacking
Item
2. patients who have failed conventional treatment (at least 1 prior treatment line), or for whom no therapy of proven efficacy exists
boolean
C2945704 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
C0087111 (UMLS CUI [2,1])
C1280519 (UMLS CUI [2,2])
C0332268 (UMLS CUI [2,3])
Malignant Neoplasms
Item
3. patients whose tumors:
boolean
C0006826 (UMLS CUI [1])
EGFR gene mutation Positive
Item
are egfr mutation-positive or
boolean
C3266992 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
EGFR gene mutation Negative | EGFR gene mutation Unknown | Disease Progression | erlotinib | Tarceva | gefitinib | Iressa | Disease Response | Stable Disease
Item
are egfr mutation-negative or unknown provided they had disease progression after achieving either response or stable disease for at least 6 months from a previous treatment with erlotinib (tarceva®) or gefitinib (iressa®)
boolean
C3266992 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
C3266992 (UMLS CUI [2,1])
C0439673 (UMLS CUI [2,2])
C0242656 (UMLS CUI [3])
C1135135 (UMLS CUI [4])
C1135136 (UMLS CUI [5])
C1122962 (UMLS CUI [6])
C0919281 (UMLS CUI [7])
C1704632 (UMLS CUI [8])
C0677946 (UMLS CUI [9])
Age
Item
4. patients aged 18 years or older
boolean
C0001779 (UMLS CUI [1])
Life Expectancy
Item
5. life expectancy of at least three (3) months
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
6. eastern cooperative oncology group (ecog, r01-0787) performance score 0-2
boolean
C1520224 (UMLS CUI [1])
Informed Consent
Item
7. written informed consent that is consistent with ich-gcp guidelines
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Major surgery | Chemotherapy | Therapeutic radiology procedure
Item
1. prior major surgery, chemotherapy or radiation therapy within 4 weeks before start of therapy.
boolean
C0679637 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
mTOR Inhibitor
Item
2. prior treatment with an mtor inhibitor within the past 4 weeks before start of therapy or concomitantly with this study
boolean
C2746052 (UMLS CUI [1])
erlotinib | Tarceva | gefitinib | Iressa | Sirolimus
Item
3. use of erlotinib (tarceva®) or gefitinib (iressa®) within 14 days of run-in treatment with sirolimus
boolean
C1135135 (UMLS CUI [1])
C1135136 (UMLS CUI [2])
C1122962 (UMLS CUI [3])
C0919281 (UMLS CUI [4])
C0072980 (UMLS CUI [5])
CNS metastases Stable | CNS metastases Symptomatic | CNS metastases Requirement Anticonvulsants | CNS metastases Requirement Steroids
Item
4. active cns metastases (defined as stable for <4 weeks and/or symptomatic and/or requiring treatment with anticonvulsants or steroids)
boolean
C0686377 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0686377 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0686377 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0003286 (UMLS CUI [3,3])
C0686377 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C0038317 (UMLS CUI [4,3])
Fasting cholesterol level Alteration Severe | Triglycerides measurement Alteration Severe | Enrollment allowed Post Initiation Hypolipidemic Agents
Item
5. severe alteration in serum fasting cholesterol (equal or more than 350 mg/dl) or triglycerides (equal or more than 400 mg/dl). patients may be allowed to enrol on the trial after initiation of lipid lowering agents.
boolean
C1282513 (UMLS CUI [1,1])
C1515926 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
C0202236 (UMLS CUI [2,1])
C1515926 (UMLS CUI [2,2])
C0205082 (UMLS CUI [2,3])
C1516879 (UMLS CUI [3,1])
C0683607 (UMLS CUI [3,2])
C0687676 (UMLS CUI [3,3])
C1704686 (UMLS CUI [3,4])
C0086440 (UMLS CUI [3,5])
Illicit drug use
Item
6. requirement for treatment with any of the prohibited concomitant medications:
boolean
C0281875 (UMLS CUI [1])
CYP3A4 Inhibitors
Item
concomitant cyp3a4 inhibitors within the past 7 days before start of therapy or concomitantly with this study.
boolean
C3850053 (UMLS CUI [1])
CYP3A4 Inducers
Item
concomitant cyp3a4 inducers within the past 14 days before start of therapy or concomitantly with this study.
boolean
C3850041 (UMLS CUI [1])
Medical contraindication Sirolimus
Item
7. any contraindications for therapy with sirolimus.
boolean
C1301624 (UMLS CUI [1,1])
C0072980 (UMLS CUI [1,2])
Hypersensitivity BIBW 2992 | Hypersensitivity Sirolimus | Hypersensitivity Rapamycin Analogue | Hypersensitivity everolimus | Hypersensitivity temsirolimus | Hypersensitivity deforolimus | Hypersensitivity Investigational New Drugs Excipient
Item
8. known hypersensitivity to bibw 2992, sirolimus or other rapamycin analogues (everolimus, temsirolimus, deforolimus, etc.) or the excipients of any of the trial drugs.
boolean
C0020517 (UMLS CUI [1,1])
C4083270 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0072980 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0072980 (UMLS CUI [3,2])
C0243071 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0541315 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C1707080 (UMLS CUI [5,2])
C0020517 (UMLS CUI [6,1])
C2713007 (UMLS CUI [6,2])
C0020517 (UMLS CUI [7,1])
C0013230 (UMLS CUI [7,2])
C0015237 (UMLS CUI [7,3])
Investigational New Drugs
Item
9. use of any investigational drug within 4 weeks before start of therapy.
boolean
C0013230 (UMLS CUI [1])
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