ID

44489

Description

A Phase II Study of Efficacy and Safety in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01327053 Sponsor: Novartis Pharmaceuticals Information provided by (Responsible Party): Novartis ( Novartis Pharmaceuticals )

Link

https://clinicaltrials.gov/show/NCT01327053

Keywords

Versions (2)
  1. 9/7/18 9/7/18 -
  2. 9/27/21 9/27/21 -
Copyright Holder

Novartis Pharmaceuticals

Uploaded on

September 27, 2021

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Basal Cell Carcinoma NCT01327053

English

Eligibility Basal Cell Carcinoma NCT01327053

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with locally advanced bcc and metastatic bcc
Description

Locally advanced and metastatic bcc

Data type

boolean

Alias
UMLS CUI [1]
C1304306
UMLS CUI [2,1]
C0007117
UMLS CUI [2,2]
C0677984
patients with 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]
C0031843
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who have had major surgery within 4 weeks of initiation of study medication
Description

History of recent major surgery

Data type

boolean

Alias
UMLS CUI [1,1]
C0679637
UMLS CUI [1,2]
C0332185
patients unable to take oral drugs or with lack of physical integrity of the upper gastrointestinal tract, or known malabsorption syndromes.
Description

Inability to take oral drugs or lack of physical integrity of the upper gastrointestinal tract, or known malabsorption syndromes

Data type

boolean

Alias
UMLS CUI [1]
C3839225
UMLS CUI [2,1]
C3203348
UMLS CUI [2,2]
C0332268
UMLS CUI [2,3]
C1947912
UMLS CUI [3]
C0024523
patients with concurrent medical conditions that may interfere or potentially affect the interpretation of the study.
Description

Interference or potential affection of the study due to concurrent medical conditions

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C4054723
UMLS CUI [1,3]
C1264692
patients with neuromuscular disorders or on concurrent treatment with drugs that may cause muscle damage.
Description

Neuromuscular disorder or concurrent treatment with drugs that may cause muscle damage

Data type

boolean

Alias
UMLS CUI [1]
C0027868
UMLS CUI [2,1]
C2827774
UMLS CUI [2,2]
C0410158
patients who are on concurrent therapy with other anti-neoplastic agents.
Description

Concurrent anti-neoplastic drug therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0003392
UMLS CUI [1,2]
C2827774
patients who have taken part in an experimental drug within 4 weeks of initiation of study medication.
Description

Recent treatment with an experimental drug

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0332185
pregnant or nursing (lactating) women
Description

Pregnant or nursing women

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
women of child bearing potential unwilling to use 2 forms of highly effective contraception throughout the study and for 3 months after the last treatment
Description

Females unwilling to use selected forms of contraception

Data type

boolean

Alias
UMLS CUI [1,1]
C0086287
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0558080
fertile males not willing to use condoms throughout the study and for 3 months after the last treatment.
Description

Males unwilling to use condoms

Data type

boolean

Alias
UMLS CUI [1,1]
C0086582
UMLS CUI [1,2]
C0558080
UMLS CUI [1,3]
C0677582
patients who are unwilling or unable to comply with the protocol.
Description

Noncompliance

Data type

boolean

Alias
UMLS CUI [1]
C0457432
Other protocol-defined inclusion/exclusion criteria
Description

Other protocol-defined inclusion/exclusion criteria

Alias
UMLS CUI-1
C1516637
other protocol-defined inclusion/exclusion criteria may apply
Description

Other protocol-defined inclusion/exclusion criteria

Data type

boolean

Alias
UMLS CUI [1]
C1516637
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Similar models

Eligibility Basal Cell Carcinoma NCT01327053

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Locally advanced and metastatic bcc
Item
patients with locally advanced bcc and metastatic bcc
boolean
C1304306 (UMLS CUI [1])
C0007117 (UMLS CUI [2,1])
C0677984 (UMLS CUI [2,2])
Adequate bone marrow, liver, and renal function
Item
patients with adequate bone marrow, liver, and renal function
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
History of recent major surgery
Item
patients who have had major surgery within 4 weeks of initiation of study medication
boolean
C0679637 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Inability to take oral drugs or lack of physical integrity of the upper gastrointestinal tract, or known malabsorption syndromes
Item
patients unable to take oral drugs or with lack of physical integrity of the upper gastrointestinal tract, or known malabsorption syndromes.
boolean
C3839225 (UMLS CUI [1])
C3203348 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
C1947912 (UMLS CUI [2,3])
C0024523 (UMLS CUI [3])
Interference or potential affection of the study due to concurrent medical conditions
Item
patients with concurrent medical conditions that may interfere or potentially affect the interpretation of the study.
boolean
C0009488 (UMLS CUI [1,1])
C4054723 (UMLS CUI [1,2])
C1264692 (UMLS CUI [1,3])
Neuromuscular disorder or concurrent treatment with drugs that may cause muscle damage
Item
patients with neuromuscular disorders or on concurrent treatment with drugs that may cause muscle damage.
boolean
C0027868 (UMLS CUI [1])
C2827774 (UMLS CUI [2,1])
C0410158 (UMLS CUI [2,2])
Concurrent anti-neoplastic drug therapy
Item
patients who are on concurrent therapy with other anti-neoplastic agents.
boolean
C0003392 (UMLS CUI [1,1])
C2827774 (UMLS CUI [1,2])
Recent treatment with an experimental drug
Item
patients who have taken part in an experimental drug within 4 weeks of initiation of study medication.
boolean
C0304229 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Pregnant or nursing women
Item
pregnant or nursing (lactating) women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Females unwilling to use selected forms of contraception
Item
women of child bearing potential unwilling to use 2 forms of highly effective contraception throughout the study and for 3 months after the last treatment
boolean
C0086287 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
Males unwilling to use condoms
Item
fertile males not willing to use condoms throughout the study and for 3 months after the last treatment.
boolean
C0086582 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0677582 (UMLS CUI [1,3])
Noncompliance
Item
patients who are unwilling or unable to comply with the protocol.
boolean
C0457432 (UMLS CUI [1])
Item Group
Other protocol-defined inclusion/exclusion criteria
C1516637 (UMLS CUI-1)
Other protocol-defined inclusion/exclusion criteria
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1])
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