ID

16536

Beschreibung

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

Stichworte

Versionen (1)
  1. 22.07.16 22.07.16 -
Hochgeladen am

22. Juli 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Carcinoma, Squamous Cell NCT00073450

Englisch

Eligibility Carcinoma, Squamous Cell NCT00073450

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Squamous cell carcinoma of the head and neck

Datentyp

boolean

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

Age

Datentyp

boolean

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

ECOG performance status

Datentyp

boolean

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

malignant disease Measurable

Datentyp

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.
Beschreibung

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

Datentyp

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
Beschreibung

Operative Surgical Procedure Status post | Therapeutic radiology procedure Status post

Datentyp

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
Beschreibung

Chemotherapy Status post

Datentyp

boolean

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

Study Protocol Laboratory Results Fulfill

Datentyp

boolean

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

Informed Consent | Compliance behavior

Datentyp

boolean

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

Childbearing Potential Contraceptive methods

Datentyp

boolean

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

Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior exposure to farnesyl transferase inhibitors
Beschreibung

Farnesyl Transferase Inhibitor Exposure to

Datentyp

boolean

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

medical condition Interferes with oral medication Intake

Datentyp

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.)
Beschreibung

QTc Prolongation Significant

Datentyp

boolean

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

Pregnancy | Breast Feeding

Datentyp

boolean

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

HIV Seropositivity | AIDS related illness

Datentyp

boolean

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

Chemotherapy | Hormone Therapy | Therapeutic radiology procedure | Immunotherapy

Datentyp

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.
Beschreibung

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

Datentyp

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
Beschreibung

Squamous cell carcinoma of nasopharynx

Datentyp

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.
Beschreibung

Malignant Neoplasms | cancer treatment

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0920425
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Ähnliche Modelle

Eligibility Carcinoma, Squamous Cell NCT00073450

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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