ID

16536

Descrição

Study of Lonafarnib in Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck (Study P02530); ODM derived from: https://clinicaltrials.gov/show/NCT00073450

Link

https://clinicaltrials.gov/show/NCT00073450

Palavras-chave

Versões (1)
  1. 22/07/2016 22/07/2016 -
Transferido a

22 de julho de 2016

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Carcinoma, Squamous Cell NCT00073450

Inglês

Eligibility Carcinoma, Squamous Cell NCT00073450

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically proven squamous cell carcinoma of the head & neck.
Descrição

Squamous cell carcinoma of the head and neck

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1168401
age greater than or equal to 18.
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance status of 0 to 1
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
measurable malignant disease.
Descrição

malignant disease Measurable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0442867
UMLS CUI [1,2]
C1513040
patients that have failed at least one platinum-containing regimen and have received no more than three prior regimens and do not have other curative treatment options.
Descrição

Regimen Platinum-Based failed | Prior Therapy Quantity | curative treatment

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0040808
UMLS CUI [1,2]
C1514162
UMLS CUI [1,3]
C0231175
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C1265611
UMLS CUI [3]
C1273390
patients must be at least 2 wks post surgery or radiation therapy
Descrição

Operative Surgical Procedure Status post | Therapeutic radiology procedure Status post

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0231290
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0231290
patients must be at least 4 weeks post chemotherapy
Descrição

Chemotherapy Status post

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0231290
meets protocol requirements for specified laboratory values.
Descrição

Study Protocol Laboratory Results Fulfill

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C1254595
UMLS CUI [1,3]
C1550543
written informed consent and cooperation of patient.
Descrição

Informed Consent | Compliance behavior

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C1321605
appropriate use of effective contraception if of childbearing potential.
Descrição

Childbearing Potential Contraceptive methods

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
no investigational drugs of any type within 30 days prior to administration.
Descrição

Investigational New Drugs

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0013230
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior exposure to farnesyl transferase inhibitors
Descrição

Farnesyl Transferase Inhibitor Exposure to

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1517132
UMLS CUI [1,2]
C0332157
medical conditions that would interfere with taking oral medications.
Descrição

medical condition Interferes with oral medication Intake

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0175795
UMLS CUI [1,4]
C1512806
patients with significant qtc prolongation at baseline (>500 msec.)
Descrição

QTc Prolongation Significant

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0855333
UMLS CUI [1,2]
C0750502
pregnant or nursing women
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
known hiv positivity or aids-related illness.
Descrição

HIV Seropositivity | AIDS related illness

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0740842
concomitant chemotherapy, hormonal therapy, radiotherapy or immunotherapy
Descrição

Chemotherapy | Hormone Therapy | Therapeutic radiology procedure | Immunotherapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0279025
UMLS CUI [3]
C1522449
UMLS CUI [4]
C0021083
patients with any signs of involvement of the dura, meninges, or brain.
Descrição

signs Involvement with Dura Mater | signs Involvement with Meninges | signs Involvement with Brain

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0220912
UMLS CUI [1,2]
C1314939
UMLS CUI [1,3]
C0013313
UMLS CUI [2,1]
C0220912
UMLS CUI [2,2]
C1314939
UMLS CUI [2,3]
C0025285
UMLS CUI [3,1]
C0220912
UMLS CUI [3,2]
C1314939
UMLS CUI [3,3]
C0006104
patients with squamous cell carcinoma of the nasopharynx
Descrição

Squamous cell carcinoma of nasopharynx

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0279698
patients who currently have other cancers or have been treated in the last 5 years for any other malignancy.
Descrição

Malignant Neoplasms | cancer treatment

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0920425
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Similar models

Eligibility Carcinoma, Squamous Cell NCT00073450

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Squamous cell carcinoma of the head and neck
Item
histologically or cytologically proven squamous cell carcinoma of the head & neck.
boolean
C1168401 (UMLS CUI [1])
Age
Item
age greater than or equal to 18.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status of 0 to 1
boolean
C1520224 (UMLS CUI [1])
malignant disease Measurable
Item
measurable malignant disease.
boolean
C0442867 (UMLS CUI [1,1])
C1513040 (UMLS CUI [1,2])
Regimen Platinum-Based failed | Prior Therapy Quantity | curative treatment
Item
patients that have failed at least one platinum-containing regimen and have received no more than three prior regimens and do not have other curative treatment options.
boolean
C0040808 (UMLS CUI [1,1])
C1514162 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
C1514463 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1273390 (UMLS CUI [3])
Operative Surgical Procedure Status post | Therapeutic radiology procedure Status post
Item
patients must be at least 2 wks post surgery or radiation therapy
boolean
C0543467 (UMLS CUI [1,1])
C0231290 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0231290 (UMLS CUI [2,2])
Chemotherapy Status post
Item
patients must be at least 4 weeks post chemotherapy
boolean
C0392920 (UMLS CUI [1,1])
C0231290 (UMLS CUI [1,2])
Study Protocol Laboratory Results Fulfill
Item
meets protocol requirements for specified laboratory values.
boolean
C2348563 (UMLS CUI [1,1])
C1254595 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Informed Consent | Compliance behavior
Item
written informed consent and cooperation of patient.
boolean
C0021430 (UMLS CUI [1])
C1321605 (UMLS CUI [2])
Childbearing Potential Contraceptive methods
Item
appropriate use of effective contraception if of childbearing potential.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Investigational New Drugs
Item
no investigational drugs of any type within 30 days prior to administration.
boolean
C0013230 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Farnesyl Transferase Inhibitor Exposure to
Item
prior exposure to farnesyl transferase inhibitors
boolean
C1517132 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
medical condition Interferes with oral medication Intake
Item
medical conditions that would interfere with taking oral medications.
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0175795 (UMLS CUI [1,3])
C1512806 (UMLS CUI [1,4])
QTc Prolongation Significant
Item
patients with significant qtc prolongation at baseline (>500 msec.)
boolean
C0855333 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnant or nursing women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
HIV Seropositivity | AIDS related illness
Item
known hiv positivity or aids-related illness.
boolean
C0019699 (UMLS CUI [1])
C0740842 (UMLS CUI [2])
Chemotherapy | Hormone Therapy | Therapeutic radiology procedure | Immunotherapy
Item
concomitant chemotherapy, hormonal therapy, radiotherapy or immunotherapy
boolean
C0392920 (UMLS CUI [1])
C0279025 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C0021083 (UMLS CUI [4])
signs Involvement with Dura Mater | signs Involvement with Meninges | signs Involvement with Brain
Item
patients with any signs of involvement of the dura, meninges, or brain.
boolean
C0220912 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C0013313 (UMLS CUI [1,3])
C0220912 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
C0025285 (UMLS CUI [2,3])
C0220912 (UMLS CUI [3,1])
C1314939 (UMLS CUI [3,2])
C0006104 (UMLS CUI [3,3])
Squamous cell carcinoma of nasopharynx
Item
patients with squamous cell carcinoma of the nasopharynx
boolean
C0279698 (UMLS CUI [1])
Malignant Neoplasms | cancer treatment
Item
patients who currently have other cancers or have been treated in the last 5 years for any other malignancy.
boolean
C0006826 (UMLS CUI [1])
C0920425 (UMLS CUI [2])
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