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ID

19734

Beskrivning

Phase 1 Clinical Trial of NPI-0052 in Patients With Advanced Solid Tumor Malignancies or Refractory Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00396864

Länk

https://clinicaltrials.gov/show/NCT00396864

Nyckelord

Versioner (2)
  1. 2017-01-24 2017-01-24 -
  2. 2017-01-24 2017-01-24 -
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24 januari 2017

DOI

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Creative Commons BY 4.0
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    Eligibility Cancer NCT00396864

    Engelsk

    Eligibility Cancer NCT00396864

    1 Formulär  
    1. StudyEvent: Eligibility
      1. Eligibility Cancer NCT00396864
    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    histologically-confirmed solid tumor malignancy (patients must be refractory to or demonstrate unacceptable toxicity towards effective therapy known to provide clinical benefit for their condition) or refractory lymphoma (patients whose disease has progressed despite standard therapy including at least one-doxorubicin-containing regimen and one anti-cd20 monoclonal antibody-containing regimen.
    Beskrivning

    Malignant Neoplasm Solid tumour | Patients Unresponsive to Treatment | Therapeutic procedure Toxic effect Unacceptable | Lymphoma Unresponsive to Treatment | Standard therapy Doxorubicin Regimen Quantity | Anti-CD20 Antibody Regimen Quantity | Disease Progression

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0006826
    UMLS CUI [1,2]
    C0280100
    UMLS CUI [2,1]
    C0030705
    UMLS CUI [2,2]
    C0205269
    UMLS CUI [3,1]
    C0087111
    UMLS CUI [3,2]
    C0600688
    UMLS CUI [3,3]
    C1883420
    UMLS CUI [4,1]
    C0024299
    UMLS CUI [4,2]
    C0205269
    UMLS CUI [5,1]
    C2936643
    UMLS CUI [5,2]
    C0013089
    UMLS CUI [5,3]
    C0040808
    UMLS CUI [5,4]
    C1265611
    UMLS CUI [6,1]
    C3891557
    UMLS CUI [6,2]
    C0040808
    UMLS CUI [6,3]
    C1265611
    UMLS CUI [7]
    C0242656
    kps ≥70%.
    Beskrivning

    Karnofsky Performance Status

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0206065
    all adverse events of any prior chemotherapy, surgery, or radiotherapy, must have resolved to nci ctcae (v. 3.0) grade ≤ 1 (except for hemoglobin).
    Beskrivning

    Chemotherapy | Operative Surgical Procedures | Therapeutic radiology procedure | Adverse events resolved CTCAE Grades

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0392920
    UMLS CUI [2]
    C0543467
    UMLS CUI [3]
    C1522449
    UMLS CUI [4,1]
    C0877248
    UMLS CUI [4,2]
    C1514893
    UMLS CUI [4,3]
    C1516728
    adequate bone marrow, renal, adrenal, pancreatic and liver function.
    Beskrivning

    Bone Marrow function | Renal function | Normal adrenal function | Pancreatic function | Liver function

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0005953
    UMLS CUI [1,2]
    C0031843
    UMLS CUI [2]
    C0232804
    UMLS CUI [3]
    C3275461
    UMLS CUI [4]
    C0232786
    UMLS CUI [5]
    C0232741
    signed informed consent.
    Beskrivning

    Informed Consent

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    administration of chemotherapy, biological, immunotherapy or investigational agent (therapeutic or diagnostic) within 28 days prior to receipt of study medication (6 weeks for nitrosoureas or mitomycin c; 12 weeks for radioimmunotherapy). major surgery, other than diagnostic surgery, within 4 weeks before first study drug administration. radiotherapy within 4 weeks.
    Beskrivning

    Chemotherapy | Biological treatment | Immunotherapy | Investigational New Drugs | Nitrosoureas | Mitomycin | Radioimmunotherapy | major surgery | Diagnostic surgical procedure | Therapeutic radiology procedure

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0392920
    UMLS CUI [2]
    C1531518
    UMLS CUI [3]
    C0021083
    UMLS CUI [4]
    C0013230
    UMLS CUI [5]
    C0028210
    UMLS CUI [6]
    C0002475
    UMLS CUI [7]
    C0085101
    UMLS CUI [8]
    C0679637
    UMLS CUI [9]
    C0522769
    UMLS CUI [10]
    C1522449
    patients that require g-csf and/or platelet support.
    Beskrivning

    Granulocyte Colony-Stimulating Factor Support Patient need for | Blood Platelets Support Patient need for

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0079459
    UMLS CUI [1,2]
    C0344211
    UMLS CUI [1,3]
    C0686904
    UMLS CUI [2,1]
    C0005821
    UMLS CUI [2,2]
    C0344211
    UMLS CUI [2,3]
    C0686904
    patients with ongoing coagulopathies.
    Beskrivning

    Blood Coagulation Disorders

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0005779
    patients with prior bone marrow transplant therapy (autologous or allogeneic).
    Beskrivning

    Autologous bone marrow transplant | Allogeneic bone marrow transplantation

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0194037
    UMLS CUI [2]
    C0149615
    patients receiving intrathecal therapy.
    Beskrivning

    intrathecal therapy

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1831734
    known brain metastases.
    Beskrivning

    Metastatic malignant neoplasm to brain

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0220650
    significant cardiac disease.
    Beskrivning

    Heart Disease Significant

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0018799
    UMLS CUI [1,2]
    C0750502
    patients with a prior hypersensitivity reaction of ctcae grade ≥ 3 to therapy containing propylene glycol or ethanol.
    Beskrivning

    Hypersensitivity Propylene glycol CTCAE Grades | Allergy to ethanol CTCAE Grades

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0072225
    UMLS CUI [1,3]
    C1516728
    UMLS CUI [2,1]
    C0740909
    UMLS CUI [2,2]
    C1516728
    pregnant or breast-feeding women. female patients must be postmenopausal, surgically sterile or they must agree to use acceptable methods of birth control. female patients with childbearing potential must have a negative serum pregnancy test. male patients must be surgically sterile or agree to use an acceptable method of contraception.
    Beskrivning

    Pregnancy | Breast Feeding | Postmenopausal state | Female Sterilization | Gender Contraceptive methods | Childbearing Potential Serum pregnancy test negative | Male sterilization

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    UMLS CUI [3]
    C0232970
    UMLS CUI [4]
    C0015787
    UMLS CUI [5,1]
    C0079399
    UMLS CUI [5,2]
    C0700589
    UMLS CUI [6,1]
    C3831118
    UMLS CUI [6,2]
    C0430061
    UMLS CUI [7]
    C0024559
    concurrent, active secondary malignancy for which the patient is receiving therapy.
    Beskrivning

    Therapeutic procedure Secondary Malignant Neoplasm

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C3266877
    active uncontrolled bacterial or fungal infection requiring systemic therapy; infection requiring parenteral antibiotics.
    Beskrivning

    Bacterial Infection Uncontrolled Requirement systemic therapy | Mycosis Uncontrolled Requirement systemic therapy | Communicable Disease Requirement Antibiotics Parenteral

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0004623
    UMLS CUI [1,2]
    C0205318
    UMLS CUI [1,3]
    C1514873
    UMLS CUI [1,4]
    C1515119
    UMLS CUI [2,1]
    C0026946
    UMLS CUI [2,2]
    C0205318
    UMLS CUI [2,3]
    C1514873
    UMLS CUI [2,4]
    C1515119
    UMLS CUI [3,1]
    C0009450
    UMLS CUI [3,2]
    C1514873
    UMLS CUI [3,3]
    C0003232
    UMLS CUI [3,4]
    C1518896
    known to be positive for hiv; active hepatitis a, b, or c infection.
    Beskrivning

    HIV Seropositivity | Hepatitis A | Hepatitis B | Hepatitis C

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0019699
    UMLS CUI [2]
    C0019159
    UMLS CUI [3]
    C0019163
    UMLS CUI [4]
    C0019196
    Tillbaka till toppen

    Similar models

    Eligibility Cancer NCT00396864

    1 Formulär
    1. StudyEvent: Eligibility
      1. Eligibility Cancer NCT00396864
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Malignant Neoplasm Solid tumour | Patients Unresponsive to Treatment | Therapeutic procedure Toxic effect Unacceptable | Lymphoma Unresponsive to Treatment | Standard therapy Doxorubicin Regimen Quantity | Anti-CD20 Antibody Regimen Quantity | Disease Progression
    Item
    histologically-confirmed solid tumor malignancy (patients must be refractory to or demonstrate unacceptable toxicity towards effective therapy known to provide clinical benefit for their condition) or refractory lymphoma (patients whose disease has progressed despite standard therapy including at least one-doxorubicin-containing regimen and one anti-cd20 monoclonal antibody-containing regimen.
    boolean
    C0006826 (UMLS CUI [1,1])
    C0280100 (UMLS CUI [1,2])
    C0030705 (UMLS CUI [2,1])
    C0205269 (UMLS CUI [2,2])
    C0087111 (UMLS CUI [3,1])
    C0600688 (UMLS CUI [3,2])
    C1883420 (UMLS CUI [3,3])
    C0024299 (UMLS CUI [4,1])
    C0205269 (UMLS CUI [4,2])
    C2936643 (UMLS CUI [5,1])
    C0013089 (UMLS CUI [5,2])
    C0040808 (UMLS CUI [5,3])
    C1265611 (UMLS CUI [5,4])
    C3891557 (UMLS CUI [6,1])
    C0040808 (UMLS CUI [6,2])
    C1265611 (UMLS CUI [6,3])
    C0242656 (UMLS CUI [7])
    Karnofsky Performance Status
    Item
    kps ≥70%.
    boolean
    C0206065 (UMLS CUI [1])
    Chemotherapy | Operative Surgical Procedures | Therapeutic radiology procedure | Adverse events resolved CTCAE Grades
    Item
    all adverse events of any prior chemotherapy, surgery, or radiotherapy, must have resolved to nci ctcae (v. 3.0) grade ≤ 1 (except for hemoglobin).
    boolean
    C0392920 (UMLS CUI [1])
    C0543467 (UMLS CUI [2])
    C1522449 (UMLS CUI [3])
    C0877248 (UMLS CUI [4,1])
    C1514893 (UMLS CUI [4,2])
    C1516728 (UMLS CUI [4,3])
    Bone Marrow function | Renal function | Normal adrenal function | Pancreatic function | Liver function
    Item
    adequate bone marrow, renal, adrenal, pancreatic and liver function.
    boolean
    C0005953 (UMLS CUI [1,1])
    C0031843 (UMLS CUI [1,2])
    C0232804 (UMLS CUI [2])
    C3275461 (UMLS CUI [3])
    C0232786 (UMLS CUI [4])
    C0232741 (UMLS CUI [5])
    Informed Consent
    Item
    signed informed consent.
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Chemotherapy | Biological treatment | Immunotherapy | Investigational New Drugs | Nitrosoureas | Mitomycin | Radioimmunotherapy | major surgery | Diagnostic surgical procedure | Therapeutic radiology procedure
    Item
    administration of chemotherapy, biological, immunotherapy or investigational agent (therapeutic or diagnostic) within 28 days prior to receipt of study medication (6 weeks for nitrosoureas or mitomycin c; 12 weeks for radioimmunotherapy). major surgery, other than diagnostic surgery, within 4 weeks before first study drug administration. radiotherapy within 4 weeks.
    boolean
    C0392920 (UMLS CUI [1])
    C1531518 (UMLS CUI [2])
    C0021083 (UMLS CUI [3])
    C0013230 (UMLS CUI [4])
    C0028210 (UMLS CUI [5])
    C0002475 (UMLS CUI [6])
    C0085101 (UMLS CUI [7])
    C0679637 (UMLS CUI [8])
    C0522769 (UMLS CUI [9])
    C1522449 (UMLS CUI [10])
    Granulocyte Colony-Stimulating Factor Support Patient need for | Blood Platelets Support Patient need for
    Item
    patients that require g-csf and/or platelet support.
    boolean
    C0079459 (UMLS CUI [1,1])
    C0344211 (UMLS CUI [1,2])
    C0686904 (UMLS CUI [1,3])
    C0005821 (UMLS CUI [2,1])
    C0344211 (UMLS CUI [2,2])
    C0686904 (UMLS CUI [2,3])
    Blood Coagulation Disorders
    Item
    patients with ongoing coagulopathies.
    boolean
    C0005779 (UMLS CUI [1])
    Autologous bone marrow transplant | Allogeneic bone marrow transplantation
    Item
    patients with prior bone marrow transplant therapy (autologous or allogeneic).
    boolean
    C0194037 (UMLS CUI [1])
    C0149615 (UMLS CUI [2])
    intrathecal therapy
    Item
    patients receiving intrathecal therapy.
    boolean
    C1831734 (UMLS CUI [1])
    Metastatic malignant neoplasm to brain
    Item
    known brain metastases.
    boolean
    C0220650 (UMLS CUI [1])
    Heart Disease Significant
    Item
    significant cardiac disease.
    boolean
    C0018799 (UMLS CUI [1,1])
    C0750502 (UMLS CUI [1,2])
    Hypersensitivity Propylene glycol CTCAE Grades | Allergy to ethanol CTCAE Grades
    Item
    patients with a prior hypersensitivity reaction of ctcae grade ≥ 3 to therapy containing propylene glycol or ethanol.
    boolean
    C0020517 (UMLS CUI [1,1])
    C0072225 (UMLS CUI [1,2])
    C1516728 (UMLS CUI [1,3])
    C0740909 (UMLS CUI [2,1])
    C1516728 (UMLS CUI [2,2])
    Pregnancy | Breast Feeding | Postmenopausal state | Female Sterilization | Gender Contraceptive methods | Childbearing Potential Serum pregnancy test negative | Male sterilization
    Item
    pregnant or breast-feeding women. female patients must be postmenopausal, surgically sterile or they must agree to use acceptable methods of birth control. female patients with childbearing potential must have a negative serum pregnancy test. male patients must be surgically sterile or agree to use an acceptable method of contraception.
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    C0232970 (UMLS CUI [3])
    C0015787 (UMLS CUI [4])
    C0079399 (UMLS CUI [5,1])
    C0700589 (UMLS CUI [5,2])
    C3831118 (UMLS CUI [6,1])
    C0430061 (UMLS CUI [6,2])
    C0024559 (UMLS CUI [7])
    Therapeutic procedure Secondary Malignant Neoplasm
    Item
    concurrent, active secondary malignancy for which the patient is receiving therapy.
    boolean
    C0087111 (UMLS CUI [1,1])
    C3266877 (UMLS CUI [1,2])
    Bacterial Infection Uncontrolled Requirement systemic therapy | Mycosis Uncontrolled Requirement systemic therapy | Communicable Disease Requirement Antibiotics Parenteral
    Item
    active uncontrolled bacterial or fungal infection requiring systemic therapy; infection requiring parenteral antibiotics.
    boolean
    C0004623 (UMLS CUI [1,1])
    C0205318 (UMLS CUI [1,2])
    C1514873 (UMLS CUI [1,3])
    C1515119 (UMLS CUI [1,4])
    C0026946 (UMLS CUI [2,1])
    C0205318 (UMLS CUI [2,2])
    C1514873 (UMLS CUI [2,3])
    C1515119 (UMLS CUI [2,4])
    C0009450 (UMLS CUI [3,1])
    C1514873 (UMLS CUI [3,2])
    C0003232 (UMLS CUI [3,3])
    C1518896 (UMLS CUI [3,4])
    HIV Seropositivity | Hepatitis A | Hepatitis B | Hepatitis C
    Item
    known to be positive for hiv; active hepatitis a, b, or c infection.
    boolean
    C0019699 (UMLS CUI [1])
    C0019159 (UMLS CUI [2])
    C0019163 (UMLS CUI [3])
    C0019196 (UMLS CUI [4])
    Tillbaka till toppen 

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