ID

31116

Beschrijving

Proteasome Inhibitor NPI-0052 and Vorinostat in Patients With Non-small Cell Lung Cancer, Pancreatic Cancer, Melanoma or Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00667082

Link

https://clinicaltrials.gov/show/NCT00667082

Trefwoorden

Versies (1)
  1. 21-07-18 21-07-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

21 juli 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Non-Small Cell Lung Cancer NCT00667082

Engels

Eligibility Non-Small Cell Lung Cancer NCT00667082

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. karnofsky performance status (kps) at 70% or more.
Beschrijving

Karnofsky Performance Status

Datatype

boolean

Alias
UMLS CUI [1]
C0206065
2. non-small cell lung cancer, pancreatic adenocarcinoma, melanoma or lymphoma for which a standard, approved therapy is not available. patients must have lesions that are evaluable by recist criteria.
Beschrijving

Non-Small Cell Lung Carcinoma | Adenocarcinoma of pancreas | Standard therapy Unavailable Melanoma | Standard therapy Unavailable Lymphoma | Lesion Evaluable

Datatype

boolean

Alias
UMLS CUI [1]
C0007131
UMLS CUI [2]
C0281361
UMLS CUI [3,1]
C2936643
UMLS CUI [3,2]
C0686905
UMLS CUI [3,3]
C0025202
UMLS CUI [4,1]
C2936643
UMLS CUI [4,2]
C0686905
UMLS CUI [4,3]
C0024299
UMLS CUI [5,1]
C0221198
UMLS CUI [5,2]
C1516986
3. all adverse events of any prior chemotherapy, surgery, or radiotherapy, must have resolved to ctcae (v. 3.0) grade 1 or less(except for hemoglobin).
Beschrijving

Adverse event Due to Prior Chemotherapy | Adverse event Due to Operative Surgical Procedures | Adverse event Due to Therapeutic radiology procedure | Resolution CTCAE Grades | Exception Hemoglobin

Datatype

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C1514457
UMLS CUI [2,1]
C0877248
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0543467
UMLS CUI [3,1]
C0877248
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C1522449
UMLS CUI [4,1]
C1514893
UMLS CUI [4,2]
C1516728
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0019046
4. adequate bone marrow, renal, liver function.
Beschrijving

Bone Marrow function | Renal function | Liver function

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
5. signed informed consent.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. recent administration of chemotherapy, biological, immunotherapy or investigational agent, major surgery, or radiotherapy.
Beschrijving

Chemotherapy | Biological treatment | Immunotherapy | Investigational New Drugs | Major surgery | Therapeutic radiology procedure

Datatype

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1531518
UMLS CUI [3]
C0021083
UMLS CUI [4]
C0013230
UMLS CUI [5]
C0679637
UMLS CUI [6]
C1522449
2. intrathecal therapy.
Beschrijving

Intrathecal therapy

Datatype

boolean

Alias
UMLS CUI [1]
C1831734
3. known brain metastases.
Beschrijving

Metastatic malignant neoplasm to brain

Datatype

boolean

Alias
UMLS CUI [1]
C0220650
4. significant cardiac disease.
Beschrijving

Heart Disease

Datatype

boolean

Alias
UMLS CUI [1]
C0018799
5. prior treatment with vorinostat or npi-0052, or other hdaci (including valproic acid) or proteasome inhibitors.
Beschrijving

Vorinostat | NPI 0052 | Histone deacetylase inhibitor | Valproic Acid | Proteasome inhibitors

Datatype

boolean

Alias
UMLS CUI [1]
C0672708
UMLS CUI [2]
C1570638
UMLS CUI [3]
C1512474
UMLS CUI [4]
C0042291
UMLS CUI [5]
C1443643
6. known allergy to any component of vorinostat. prior hypersensitivity reaction of ctcae grade > 3 to therapy containing propylene glycol or ethanol.
Beschrijving

Hypersensitivity Vorinostat Component | Hypersensitivity CTCAE Grades Propylene glycol | Hypersensitivity CTCAE Grades Ethanol

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0672708
UMLS CUI [1,3]
C1705248
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1516728
UMLS CUI [2,3]
C0072225
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C1516728
UMLS CUI [3,3]
C0001962
7. pregnant or breast-feeding women.
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
8. concurrent, active secondary malignancy for which the patient is receiving therapy.
Beschrijving

Therapeutic procedure Secondary Malignant Neoplasm

Datatype

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C3266877
9. significant active infection.
Beschrijving

Communicable Disease

Datatype

boolean

Alias
UMLS CUI [1]
C0009450
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Similar models

Eligibility Non-Small Cell Lung Cancer NCT00667082

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Karnofsky Performance Status
Item
1. karnofsky performance status (kps) at 70% or more.
boolean
C0206065 (UMLS CUI [1])
Non-Small Cell Lung Carcinoma | Adenocarcinoma of pancreas | Standard therapy Unavailable Melanoma | Standard therapy Unavailable Lymphoma | Lesion Evaluable
Item
2. non-small cell lung cancer, pancreatic adenocarcinoma, melanoma or lymphoma for which a standard, approved therapy is not available. patients must have lesions that are evaluable by recist criteria.
boolean
C0007131 (UMLS CUI [1])
C0281361 (UMLS CUI [2])
C2936643 (UMLS CUI [3,1])
C0686905 (UMLS CUI [3,2])
C0025202 (UMLS CUI [3,3])
C2936643 (UMLS CUI [4,1])
C0686905 (UMLS CUI [4,2])
C0024299 (UMLS CUI [4,3])
C0221198 (UMLS CUI [5,1])
C1516986 (UMLS CUI [5,2])
Adverse event Due to Prior Chemotherapy | Adverse event Due to Operative Surgical Procedures | Adverse event Due to Therapeutic radiology procedure | Resolution CTCAE Grades | Exception Hemoglobin
Item
3. all adverse events of any prior chemotherapy, surgery, or radiotherapy, must have resolved to ctcae (v. 3.0) grade 1 or less(except for hemoglobin).
boolean
C0877248 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C1514457 (UMLS CUI [1,3])
C0877248 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0543467 (UMLS CUI [2,3])
C0877248 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C1522449 (UMLS CUI [3,3])
C1514893 (UMLS CUI [4,1])
C1516728 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0019046 (UMLS CUI [5,2])
Bone Marrow function | Renal function | Liver function
Item
4. adequate bone marrow, renal, liver function.
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
Informed Consent
Item
5. signed informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Chemotherapy | Biological treatment | Immunotherapy | Investigational New Drugs | Major surgery | Therapeutic radiology procedure
Item
1. recent administration of chemotherapy, biological, immunotherapy or investigational agent, major surgery, or radiotherapy.
boolean
C0392920 (UMLS CUI [1])
C1531518 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
C0013230 (UMLS CUI [4])
C0679637 (UMLS CUI [5])
C1522449 (UMLS CUI [6])
Intrathecal therapy
Item
2. intrathecal therapy.
boolean
C1831734 (UMLS CUI [1])
Metastatic malignant neoplasm to brain
Item
3. known brain metastases.
boolean
C0220650 (UMLS CUI [1])
Heart Disease
Item
4. significant cardiac disease.
boolean
C0018799 (UMLS CUI [1])
Vorinostat | NPI 0052 | Histone deacetylase inhibitor | Valproic Acid | Proteasome inhibitors
Item
5. prior treatment with vorinostat or npi-0052, or other hdaci (including valproic acid) or proteasome inhibitors.
boolean
C0672708 (UMLS CUI [1])
C1570638 (UMLS CUI [2])
C1512474 (UMLS CUI [3])
C0042291 (UMLS CUI [4])
C1443643 (UMLS CUI [5])
Hypersensitivity Vorinostat Component | Hypersensitivity CTCAE Grades Propylene glycol | Hypersensitivity CTCAE Grades Ethanol
Item
6. known allergy to any component of vorinostat. prior hypersensitivity reaction of ctcae grade > 3 to therapy containing propylene glycol or ethanol.
boolean
C0020517 (UMLS CUI [1,1])
C0672708 (UMLS CUI [1,2])
C1705248 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
C0072225 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C1516728 (UMLS CUI [3,2])
C0001962 (UMLS CUI [3,3])
Pregnancy | Breast Feeding
Item
7. pregnant or breast-feeding women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Therapeutic procedure Secondary Malignant Neoplasm
Item
8. concurrent, active secondary malignancy for which the patient is receiving therapy.
boolean
C0087111 (UMLS CUI [1,1])
C3266877 (UMLS CUI [1,2])
Communicable Disease
Item
9. significant active infection.
boolean
C0009450 (UMLS CUI [1])
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