ID

44739

Descripción

Dacomitinib (PF-00299804) in Advanced/Metastatic Squamous Cell Carcinoma of the Penis; ODM derived from: https://clinicaltrials.gov/show/NCT01728233

Link

https://clinicaltrials.gov/show/NCT01728233

Palabras clave

Versiones (1)
  1. 10/11/21 10/11/21 -
Titular de derechos de autor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano; Pfizer

Subido en

10 de noviembre de 2021

DOI

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Licencia

Creative Commons BY-NC 4.0
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Eligibility Penile Neoplasms NCT01728233

Inglés

Eligibility Penile Neoplasms NCT01728233

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must provide written informed consent
Descripción

written informed consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
eastern cooperative oncology group performance status of at least 1
Descripción

eastern cooperative oncology group performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
cytologically or histologically proven diagnosis of scc of the penis
Descripción

cytologically or histologically proven diagnosis of scc of the penis

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0030851
UMLS CUI [1,2]
C0075091
UMLS CUI [1,3]
C0205471
UMLS CUI [2,1]
C0030851
UMLS CUI [2,2]
C0075091
UMLS CUI [2,3]
C0679557
uni- or bidimensionally measurable disease as defined by recist v1.1 criteria
Descripción

uni- or bidimensionally measurable disease as defined by recist v1.1 criteria

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0439534
UMLS CUI [1,2]
C0205447
UMLS CUI [1,3]
C1513041
UMLS CUI [1,4]
C1709926
UMLS CUI [2,1]
C0439534
UMLS CUI [2,2]
C3844700
UMLS CUI [2,3]
C1513041
UMLS CUI [2,4]
C1709926
clinical stage n2-3 and/or m1 (tnm 2002)
Descripción

TNM clinical stage

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3258246
locoregional relapse after prior major surgery/ies (either single or multiple)
Descripción

locoregional relapse after prior major surgery/ies

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0744961
UMLS CUI [1,2]
C0035020
UMLS CUI [1,3]
C1947913
no prior systemic therapy except for the administration of vincristine-bleomycin-methotrexate (vbm) chemotherapy for superficial disease if administered at least 6 months prior to study enrollment
Descripción

no prior systemic therapy except for vincristine-bleomycin-methotrexate chemotherapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1883256
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0078140
UMLS CUI [1,4]
C0332185
UMLS CUI [1,5]
C1705847
adequate bone marrow, liver and renal function
Descripción

adequate bone marrow, liver and renal function

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0678852
UMLS CUI [1,3]
C0205411
UMLS CUI [1,4]
C0232741
UMLS CUI [1,5]
C0232804
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
central nervous system (cns) metastases or leptomeningeal carcinomatosis
Descripción

central nervous system (cns) metastases or leptomeningeal carcinomatosis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0279130
UMLS CUI [2]
C0220654
history of active serious cardiovascular, cerebrovascular, pulmonary co-morbidities
Descripción

history of cardiovascular, cerebrovascular, pulmonary co-morbidities

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0007222
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0007820
UMLS CUI [3,1]
C0262926
UMLS CUI [3,2]
C0024115
previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except cervical carcinoma in situ, treated basal cell carcinoma or any cancer curatively treated > 5 years prior to study entry.
Descripción

previous or concurrent cancer

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C0205420
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Similar models

Eligibility Penile Neoplasms NCT01728233

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
written informed consent
Item
patients must provide written informed consent
boolean
C0021430 (UMLS CUI [1])
eastern cooperative oncology group performance status
Item
eastern cooperative oncology group performance status of at least 1
boolean
C1520224 (UMLS CUI [1])
cytologically or histologically proven diagnosis of scc of the penis
Item
cytologically or histologically proven diagnosis of scc of the penis
boolean
C0030851 (UMLS CUI [1,1])
C0075091 (UMLS CUI [1,2])
C0205471 (UMLS CUI [1,3])
C0030851 (UMLS CUI [2,1])
C0075091 (UMLS CUI [2,2])
C0679557 (UMLS CUI [2,3])
uni- or bidimensionally measurable disease as defined by recist v1.1 criteria
Item
uni- or bidimensionally measurable disease as defined by recist v1.1 criteria
boolean
C0439534 (UMLS CUI [1,1])
C0205447 (UMLS CUI [1,2])
C1513041 (UMLS CUI [1,3])
C1709926 (UMLS CUI [1,4])
C0439534 (UMLS CUI [2,1])
C3844700 (UMLS CUI [2,2])
C1513041 (UMLS CUI [2,3])
C1709926 (UMLS CUI [2,4])
TNM clinical stage
Item
clinical stage n2-3 and/or m1 (tnm 2002)
boolean
C3258246 (UMLS CUI [1])
locoregional relapse after prior major surgery/ies
Item
locoregional relapse after prior major surgery/ies (either single or multiple)
boolean
C0744961 (UMLS CUI [1,1])
C0035020 (UMLS CUI [1,2])
C1947913 (UMLS CUI [1,3])
no prior systemic therapy except for vincristine-bleomycin-methotrexate chemotherapy
Item
no prior systemic therapy except for the administration of vincristine-bleomycin-methotrexate (vbm) chemotherapy for superficial disease if administered at least 6 months prior to study enrollment
boolean
C1883256 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0078140 (UMLS CUI [1,3])
C0332185 (UMLS CUI [1,4])
C1705847 (UMLS CUI [1,5])
adequate bone marrow, liver and renal function
Item
adequate bone marrow, liver and renal function
boolean
C0005953 (UMLS CUI [1,1])
C0678852 (UMLS CUI [1,2])
C0205411 (UMLS CUI [1,3])
C0232741 (UMLS CUI [1,4])
C0232804 (UMLS CUI [1,5])
Item Group
C0680251 (UMLS CUI)
central nervous system (cns) metastases or leptomeningeal carcinomatosis
Item
central nervous system (cns) metastases or leptomeningeal carcinomatosis
boolean
C0279130 (UMLS CUI [1])
C0220654 (UMLS CUI [2])
history of cardiovascular, cerebrovascular, pulmonary co-morbidities
Item
history of active serious cardiovascular, cerebrovascular, pulmonary co-morbidities
boolean
C0262926 (UMLS CUI [1,1])
C0007222 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0007820 (UMLS CUI [2,2])
C0262926 (UMLS CUI [3,1])
C0024115 (UMLS CUI [3,2])
previous or concurrent cancer
Item
previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except cervical carcinoma in situ, treated basal cell carcinoma or any cancer curatively treated > 5 years prior to study entry.
boolean
C0006826 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0006826 (UMLS CUI [2,1])
C0205420 (UMLS CUI [2,2])
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