ID

44739

Description

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

Keywords

Versions (1)
  1. 11/10/21 11/10/21 -
Copyright Holder

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano; Pfizer

Uploaded on

November 10, 2021

DOI

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License

Creative Commons BY-NC 4.0
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Eligibility Penile Neoplasms NCT01728233

English

Eligibility Penile Neoplasms NCT01728233

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must provide written informed consent
Description

written informed consent

Data type

boolean

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

eastern cooperative oncology group performance status

Data type

boolean

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

cytologically or histologically proven diagnosis of scc of the penis

Data type

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
Description

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

Data type

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)
Description

TNM clinical stage

Data type

boolean

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

locoregional relapse after prior major surgery/ies

Data type

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
Description

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

Data type

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
Description

adequate bone marrow, liver and renal function

Data type

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
Description

Exclusion Criteria

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

central nervous system (cns) metastases or leptomeningeal carcinomatosis

Data type

boolean

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

history of cardiovascular, cerebrovascular, pulmonary co-morbidities

Data type

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.
Description

previous or concurrent cancer

Data type

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 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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