ID

18393

Descripción

A Phase 1/2 Trial of Perifosine in the Treatment of Non-Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00399789

Link

https://clinicaltrials.gov/show/NCT00399789

Palabras clave

Versiones (1)
  1. 2/11/16 2/11/16 -
Subido en

2 de noviembre de 2016

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Non Small Cell Lung Cancer NCT00399789

Inglés

Eligibility Non Small Cell Lung Cancer NCT00399789

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must have histologically or cytologically confirmed diagnosis of non-small cell lung cancer, must have progressed despite standard therapy and must not be candidates for surgical or combined modality therapy.
Descripción

Non-Small Cell Lung Carcinoma | Standard of Care | Disease Progression | Indication Operative Surgical Procedures | Indication Combined Modality Therapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0007131
UMLS CUI [2]
C2936643
UMLS CUI [3]
C0242656
UMLS CUI [4,1]
C3146298
UMLS CUI [4,2]
C0543467
UMLS CUI [5,1]
C3146298
UMLS CUI [5,2]
C0009429
at least 18 years of age.
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
patients should have received at least one but no more than two prior chemotherapy regimens for metastatic disease. the study chairman or medical monitor will consider extenuating circumstances for patients with more than two such regimens.
Descripción

Prior Chemotherapy Quantity Neoplasm Metastasis

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0027627
patients must have measurable disease. since the outcome for a patient is to be based on response using recist criteria, the patient must have at least one measurable lesion that can be accurately measured in at least one dimension and fit one of the following criteria: longest diameter 20 mm using conventional techniques or 10 mm with spiral ct scan.
Descripción

Measurable Disease | Lesion Measurable Quantity | Lesion Measurable Dimensions Quantity | Lesion Measurable Diameter | Measurement technique conventional | Tomography, Spiral Computed

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C1513040
UMLS CUI [2,3]
C1265611
UMLS CUI [3,1]
C0221198
UMLS CUI [3,2]
C1513040
UMLS CUI [3,3]
C0439534
UMLS CUI [3,4]
C1265611
UMLS CUI [4,1]
C0221198
UMLS CUI [4,2]
C1513040
UMLS CUI [4,3]
C1301886
UMLS CUI [5,1]
C0242485
UMLS CUI [5,2]
C0439858
UMLS CUI [6]
C0860888
patients must have a life expectancy of more than 3 months.
Descripción

Life Expectancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023671
patients should have a performance status of 0 to 1 according to the ecog criteria. however, patients with ecog performance status of 2 may be admitted with approval from the study chairman or medical monitor.
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
female patients who are pregnant or lactating are ineligible. all females of childbearing potential must have a negative serum pregnancy test within 72 hours of treatment. men and women of childbearing potential must agree to employ adequate contraception to prevent pregnancy while on therapy and for four weeks after the completion of treatment.
Descripción

Pregnancy | Breast Feeding | Childbearing Potential Serum pregnancy test negative | Fertility Contraceptive methods

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0430061
UMLS CUI [4,1]
C0015895
UMLS CUI [4,2]
C0700589
patients must have ability to understand and the willingness to sign a written informed consent document.
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with rapidly progressing disease, as defined by progression within 12 weeks of initiation of the previous regimen.
Descripción

Rapid disease progression

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1834700
patients receiving any other investigational agents or devices.
Descripción

Investigational New Drugs | Investigational Medical Device

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C2346570
history of allergic reactions attributed to compounds of similar chemical or biologic composition to perifosine (miltefosine or edelfosine).
Descripción

Allergic Reaction Compound perifosine Similar | Allergic Reaction miltefosine | Allergic Reaction edelfosine

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C1706082
UMLS CUI [1,3]
C0754570
UMLS CUI [1,4]
C2348205
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0068006
UMLS CUI [3,1]
C1527304
UMLS CUI [3,2]
C0044549
uncontrolled intercurrent illness including, but not limited to, ongoing or active infection and psychiatric illness/social situations that would limit compliance with study requirements.
Descripción

Illness Uncontrolled | Communicable Diseases | Mental disorder Protocol Compliance Limited | social situation Protocol Compliance Limited

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0009450
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C0525058
UMLS CUI [3,3]
C0439801
UMLS CUI [4,1]
C0748872
UMLS CUI [4,2]
C0525058
UMLS CUI [4,3]
C0439801
hiv-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with perifosine.
Descripción

Antiretroviral therapy Combined HIV Seropositivity | Pharmacokinetic interaction Related perifosine

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1963724
UMLS CUI [1,2]
C0205195
UMLS CUI [1,3]
C0019699
UMLS CUI [2,1]
C1868980
UMLS CUI [2,2]
C0439849
UMLS CUI [2,3]
C0754570
patients with a history of unstable or newly diagnosed angina pectoris, recent myocardial infarction (within 6 months of enrollment) or new york heart assoc. class ii-iv congestive heart failure.
Descripción

Angina, Unstable | Angina Pectoris | Myocardial Infarction Recent | Congestive heart failure | New York Heart Association Classification

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0002965
UMLS CUI [2]
C0002962
UMLS CUI [3,1]
C0027051
UMLS CUI [3,2]
C0332185
UMLS CUI [4]
C0018802
UMLS CUI [5]
C1275491
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Similar models

Eligibility Non Small Cell Lung Cancer NCT00399789

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma | Standard of Care | Disease Progression | Indication Operative Surgical Procedures | Indication Combined Modality Therapy
Item
patients must have histologically or cytologically confirmed diagnosis of non-small cell lung cancer, must have progressed despite standard therapy and must not be candidates for surgical or combined modality therapy.
boolean
C0007131 (UMLS CUI [1])
C2936643 (UMLS CUI [2])
C0242656 (UMLS CUI [3])
C3146298 (UMLS CUI [4,1])
C0543467 (UMLS CUI [4,2])
C3146298 (UMLS CUI [5,1])
C0009429 (UMLS CUI [5,2])
Age
Item
at least 18 years of age.
boolean
C0001779 (UMLS CUI [1])
Prior Chemotherapy Quantity Neoplasm Metastasis
Item
patients should have received at least one but no more than two prior chemotherapy regimens for metastatic disease. the study chairman or medical monitor will consider extenuating circumstances for patients with more than two such regimens.
boolean
C1514457 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
Measurable Disease | Lesion Measurable Quantity | Lesion Measurable Dimensions Quantity | Lesion Measurable Diameter | Measurement technique conventional | Tomography, Spiral Computed
Item
patients must have measurable disease. since the outcome for a patient is to be based on response using recist criteria, the patient must have at least one measurable lesion that can be accurately measured in at least one dimension and fit one of the following criteria: longest diameter 20 mm using conventional techniques or 10 mm with spiral ct scan.
boolean
C1513041 (UMLS CUI [1])
C0221198 (UMLS CUI [2,1])
C1513040 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0221198 (UMLS CUI [3,1])
C1513040 (UMLS CUI [3,2])
C0439534 (UMLS CUI [3,3])
C1265611 (UMLS CUI [3,4])
C0221198 (UMLS CUI [4,1])
C1513040 (UMLS CUI [4,2])
C1301886 (UMLS CUI [4,3])
C0242485 (UMLS CUI [5,1])
C0439858 (UMLS CUI [5,2])
C0860888 (UMLS CUI [6])
Life Expectancy
Item
patients must have a life expectancy of more than 3 months.
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
patients should have a performance status of 0 to 1 according to the ecog criteria. however, patients with ecog performance status of 2 may be admitted with approval from the study chairman or medical monitor.
boolean
C1520224 (UMLS CUI [1])
Pregnancy | Breast Feeding | Childbearing Potential Serum pregnancy test negative | Fertility Contraceptive methods
Item
female patients who are pregnant or lactating are ineligible. all females of childbearing potential must have a negative serum pregnancy test within 72 hours of treatment. men and women of childbearing potential must agree to employ adequate contraception to prevent pregnancy while on therapy and for four weeks after the completion of treatment.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0430061 (UMLS CUI [3,2])
C0015895 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
Informed Consent
Item
patients must have ability to understand and the willingness to sign a written informed consent document.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Rapid disease progression
Item
patients with rapidly progressing disease, as defined by progression within 12 weeks of initiation of the previous regimen.
boolean
C1834700 (UMLS CUI [1])
Investigational New Drugs | Investigational Medical Device
Item
patients receiving any other investigational agents or devices.
boolean
C0013230 (UMLS CUI [1])
C2346570 (UMLS CUI [2])
Allergic Reaction Compound perifosine Similar | Allergic Reaction miltefosine | Allergic Reaction edelfosine
Item
history of allergic reactions attributed to compounds of similar chemical or biologic composition to perifosine (miltefosine or edelfosine).
boolean
C1527304 (UMLS CUI [1,1])
C1706082 (UMLS CUI [1,2])
C0754570 (UMLS CUI [1,3])
C2348205 (UMLS CUI [1,4])
C1527304 (UMLS CUI [2,1])
C0068006 (UMLS CUI [2,2])
C1527304 (UMLS CUI [3,1])
C0044549 (UMLS CUI [3,2])
Illness Uncontrolled | Communicable Diseases | Mental disorder Protocol Compliance Limited | social situation Protocol Compliance Limited
Item
uncontrolled intercurrent illness including, but not limited to, ongoing or active infection and psychiatric illness/social situations that would limit compliance with study requirements.
boolean
C0221423 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0004936 (UMLS CUI [3,1])
C0525058 (UMLS CUI [3,2])
C0439801 (UMLS CUI [3,3])
C0748872 (UMLS CUI [4,1])
C0525058 (UMLS CUI [4,2])
C0439801 (UMLS CUI [4,3])
Antiretroviral therapy Combined HIV Seropositivity | Pharmacokinetic interaction Related perifosine
Item
hiv-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with perifosine.
boolean
C1963724 (UMLS CUI [1,1])
C0205195 (UMLS CUI [1,2])
C0019699 (UMLS CUI [1,3])
C1868980 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C0754570 (UMLS CUI [2,3])
Angina, Unstable | Angina Pectoris | Myocardial Infarction Recent | Congestive heart failure | New York Heart Association Classification
Item
patients with a history of unstable or newly diagnosed angina pectoris, recent myocardial infarction (within 6 months of enrollment) or new york heart assoc. class ii-iv congestive heart failure.
boolean
C0002965 (UMLS CUI [1])
C0002962 (UMLS CUI [2])
C0027051 (UMLS CUI [3,1])
C0332185 (UMLS CUI [3,2])
C0018802 (UMLS CUI [4])
C1275491 (UMLS CUI [5])
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