ID

31551

Description

A Study in Ovarian, Non-Small Cell Lung, Prostate, Colorectal, Gastroesophageal Cancers, and Squamous Cell Carcinoma of the Head and Neck; ODM derived from: https://clinicaltrials.gov/show/NCT01059643 Sponsor: Eli Lilly and Company Information provided by (Responsible Party): Eli Lilly and Company

Link

https://clinicaltrials.gov/show/NCT01059643

Keywords

Versions (1)
  1. 9/3/18 9/3/18 -
Copyright Holder

Eli Lilly and Company

Uploaded on

September 3, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Ovarian, Non-Small Cell Lung, Prostate, Colorectal, Gastroesophageal Cancers and Squamous Cell Carcinoma of the Head and Neck NCT01059643

English

Eligibility Ovarian, Non-Small Cell Lung, Prostate, Colorectal, Gastroesophageal Cancers and Squamous Cell Carcinoma of the Head and Neck NCT01059643

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of ovarian, non-small cell lung, prostate, colorectal, gastroesophageal cancer, or squamous cell cancer of the head and neck
Description

Diagnosis of ovarian, non-small cell lung, prostate, colorectal, gastroesophageal cancer, or squamous cell cancer of the head and neck

Data type

boolean

Alias
UMLS CUI [1]
C0029925
UMLS CUI [2]
C0007131
UMLS CUI [3]
C0600139
UMLS CUI [4]
C0009402
UMLS CUI [5]
C1112160
UMLS CUI [6]
C1168401
have measurable disease defined by response evaluation criteria in solid tumors (recist) 1.1 guidelines (except prostate cancer patients)
Description

Measurable disease according to recist criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1709926
have an eastern cooperative oncology group (ecog) performance status of 0 to 1
Description

Ecog performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
are willing to follow study procedures for the duration of the study
Description

Compliance

Data type

boolean

Alias
UMLS CUI [1]
C1321605
are willing to use an approved contraceptive method during treatment and for 3 months after discontinuation of study treatment
Description

Willing to use contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
have a serious preexisting medical condition that would preclude participation in the study
Description

Medical contraindication

Data type

boolean

Alias
UMLS CUI [1]
C1301624
are pregnant or lactating
Description

Pregnancy or lactation

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0022925
have received treatment within 28 days of first dose of ly2523355 with a drug that has not received regulatory approval for any indication
Description

Concurrent experimental drug treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0332185
have symptomatic, untreated or uncontrolled central nervous system (cns) metastases
Description

Symptomatic, untreated or uncontrolled cns metastases

Data type

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C0686377
UMLS CUI [2,2]
C0205318
UMLS CUI [3,1]
C0686377
UMLS CUI [3,2]
C0332155
have a second active primary malignancy or a history of a second malignancy requiring cytotoxic therapy
Description

Concurrent cytotoxic therapy due to other malignant disease

Data type

boolean

Alias
UMLS CUI [1,1]
C2827774
UMLS CUI [1,2]
C0677881
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C0006826
UMLS CUI [2,1]
C1514457
UMLS CUI [2,2]
C0677881
UMLS CUI [2,3]
C0205394
UMLS CUI [2,4]
C0006826
have qtc interval greater than 470 msec or intraventricular conduction delay (ivcd) with qrs greater than 120 msec on screening electrocardiogram (ecg)
Description

Prolonged qtc interval or intraventricular conduction delay on screening ecg

Data type

boolean

Alias
UMLS CUI [1]
C4015677
UMLS CUI [2]
C1882112
have active symptomatic fungal, bacterial, and/or known viral infection including active human immunodeficiency virus (hiv) or viral (a, b, c) hepatitis
Description

Active infection including hiv, hepatitis a,b or c

Data type

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0019693
UMLS CUI [3]
C0019163
UMLS CUI [4]
C0019196
UMLS CUI [5]
C0019159
patients with pneumonia, evidence of obstructive pneumonitis, other respiratory infections, or infection from other sources are to be excluded
Description

Respiratory infections including pneumonia, evidence of obstructive pneumonitis; as well infection from other sources

Data type

boolean

Alias
UMLS CUI [1]
C0035243
UMLS CUI [2]
C0032285
UMLS CUI [3,1]
C0221725
UMLS CUI [3,2]
C3714636
UMLS CUI [4,1]
C0449426
UMLS CUI [4,2]
C0205394
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Similar models

Eligibility Ovarian, Non-Small Cell Lung, Prostate, Colorectal, Gastroesophageal Cancers and Squamous Cell Carcinoma of the Head and Neck NCT01059643

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diagnosis of ovarian, non-small cell lung, prostate, colorectal, gastroesophageal cancer, or squamous cell cancer of the head and neck
Item
diagnosis of ovarian, non-small cell lung, prostate, colorectal, gastroesophageal cancer, or squamous cell cancer of the head and neck
boolean
C0029925 (UMLS CUI [1])
C0007131 (UMLS CUI [2])
C0600139 (UMLS CUI [3])
C0009402 (UMLS CUI [4])
C1112160 (UMLS CUI [5])
C1168401 (UMLS CUI [6])
Measurable disease according to recist criteria
Item
have measurable disease defined by response evaluation criteria in solid tumors (recist) 1.1 guidelines (except prostate cancer patients)
boolean
C1513041 (UMLS CUI [1,1])
C1709926 (UMLS CUI [1,2])
Ecog performance status
Item
have an eastern cooperative oncology group (ecog) performance status of 0 to 1
boolean
C1520224 (UMLS CUI [1])
Compliance
Item
are willing to follow study procedures for the duration of the study
boolean
C1321605 (UMLS CUI [1])
Willing to use contraceptive methods
Item
are willing to use an approved contraceptive method during treatment and for 3 months after discontinuation of study treatment
boolean
C0700589 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Medical contraindication
Item
have a serious preexisting medical condition that would preclude participation in the study
boolean
C1301624 (UMLS CUI [1])
Pregnancy or lactation
Item
are pregnant or lactating
boolean
C0032961 (UMLS CUI [1])
C0022925 (UMLS CUI [2])
Concurrent experimental drug treatment
Item
have received treatment within 28 days of first dose of ly2523355 with a drug that has not received regulatory approval for any indication
boolean
C0304229 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Symptomatic, untreated or uncontrolled cns metastases
Item
have symptomatic, untreated or uncontrolled central nervous system (cns) metastases
boolean
C0686377 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0686377 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0686377 (UMLS CUI [3,1])
C0332155 (UMLS CUI [3,2])
Concurrent cytotoxic therapy due to other malignant disease
Item
have a second active primary malignancy or a history of a second malignancy requiring cytotoxic therapy
boolean
C2827774 (UMLS CUI [1,1])
C0677881 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0006826 (UMLS CUI [1,4])
C1514457 (UMLS CUI [2,1])
C0677881 (UMLS CUI [2,2])
C0205394 (UMLS CUI [2,3])
C0006826 (UMLS CUI [2,4])
Prolonged qtc interval or intraventricular conduction delay on screening ecg
Item
have qtc interval greater than 470 msec or intraventricular conduction delay (ivcd) with qrs greater than 120 msec on screening electrocardiogram (ecg)
boolean
C4015677 (UMLS CUI [1])
C1882112 (UMLS CUI [2])
Active infection including hiv, hepatitis a,b or c
Item
have active symptomatic fungal, bacterial, and/or known viral infection including active human immunodeficiency virus (hiv) or viral (a, b, c) hepatitis
boolean
C0009450 (UMLS CUI [1])
C0019693 (UMLS CUI [2])
C0019163 (UMLS CUI [3])
C0019196 (UMLS CUI [4])
C0019159 (UMLS CUI [5])
Respiratory infections including pneumonia, evidence of obstructive pneumonitis; as well infection from other sources
Item
patients with pneumonia, evidence of obstructive pneumonitis, other respiratory infections, or infection from other sources are to be excluded
boolean
C0035243 (UMLS CUI [1])
C0032285 (UMLS CUI [2])
C0221725 (UMLS CUI [3,1])
C3714636 (UMLS CUI [3,2])
C0449426 (UMLS CUI [4,1])
C0205394 (UMLS CUI [4,2])
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