ID

32391

Description

Safety and Efficacy of GMX1777 in the Treatment of Refractory Solid Tumors or Lymphomas; ODM derived from: https://clinicaltrials.gov/show/NCT00457574

Link

https://clinicaltrials.gov/show/NCT00457574

Keywords

Versions (1)
  1. 10/29/18 10/29/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 29, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Solid Tumors and Lymphomas NCT00457574

English

Eligibility Solid Tumors and Lymphomas NCT00457574

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must have a histologically or cytologically confirmed solid tumor or lymphoma
Description

Solid Neoplasm | Lymphoma

Data type

boolean

Alias
UMLS CUI [1]
C0280100
UMLS CUI [2]
C0024299
no limitations on allowable type and amount of prior therapy.
Description

Limitation Absent Prior Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0449295
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C1514463
patients must have a life expectancy of greater than 8 weeks
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
patients must have normal organ and marrow function
Description

Organ function | Bone Marrow function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
patients must be willing to submit blood sampling for planned pk analysis
Description

Blood sampling Pharmacokinetic aspects

Data type

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0031328
patients must have the ability to understand and willingness to sign a written informed consent form
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
no other agents or therapies administered with the intent to treat malignancy
Description

Pharmaceutical Preparations Other Cancer treatment | Cancer treatment Other

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0920425
UMLS CUI [2,1]
C0920425
UMLS CUI [2,2]
C0205394
patients with prior exposure to gmx1777 or gmx1778
Description

Exposure to GMX1777 | Exposure to GMX 1778

Data type

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C2346839
UMLS CUI [2,1]
C0332157
UMLS CUI [2,2]
C2713488
uncontrolled, intercurrent illness
Description

Comorbidity Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
pregnant women and women who are breast feeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Solid Tumors and Lymphomas NCT00457574

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Solid Neoplasm | Lymphoma
Item
patients must have a histologically or cytologically confirmed solid tumor or lymphoma
boolean
C0280100 (UMLS CUI [1])
C0024299 (UMLS CUI [2])
Limitation Absent Prior Therapy
Item
no limitations on allowable type and amount of prior therapy.
boolean
C0449295 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1514463 (UMLS CUI [1,3])
Life Expectancy
Item
patients must have a life expectancy of greater than 8 weeks
boolean
C0023671 (UMLS CUI [1])
Organ function | Bone Marrow function
Item
patients must have normal organ and marrow function
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
Blood sampling Pharmacokinetic aspects
Item
patients must be willing to submit blood sampling for planned pk analysis
boolean
C0005834 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
Informed Consent
Item
patients must have the ability to understand and willingness to sign a written informed consent form
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pharmaceutical Preparations Other Cancer treatment | Cancer treatment Other
Item
no other agents or therapies administered with the intent to treat malignancy
boolean
C0013227 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0920425 (UMLS CUI [1,3])
C0920425 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
Exposure to GMX1777 | Exposure to GMX 1778
Item
patients with prior exposure to gmx1777 or gmx1778
boolean
C0332157 (UMLS CUI [1,1])
C2346839 (UMLS CUI [1,2])
C0332157 (UMLS CUI [2,1])
C2713488 (UMLS CUI [2,2])
Comorbidity Uncontrolled
Item
uncontrolled, intercurrent illness
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnant women and women who are breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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