ID

19734

Description

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

Link

https://clinicaltrials.gov/show/NCT00396864

Keywords

Versions (2)
  1. 1/24/17 1/24/17 -
  2. 1/24/17 1/24/17 -
Uploaded on

January 24, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Cancer NCT00396864

English

Eligibility Cancer NCT00396864

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Cancer NCT00396864
Inclusion Criteria
Description

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.
Description

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

Data type

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%.
Description

Karnofsky Performance Status

Data type

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).
Description

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

Data type

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.
Description

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

Data type

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.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

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.
Description

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

Data type

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.
Description

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

Data type

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.
Description

Blood Coagulation Disorders

Data type

boolean

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

Autologous bone marrow transplant | Allogeneic bone marrow transplantation

Data type

boolean

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

intrathecal therapy

Data type

boolean

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

Metastatic malignant neoplasm to brain

Data type

boolean

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

Heart Disease Significant

Data type

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.
Description

Hypersensitivity Propylene glycol CTCAE Grades | Allergy to ethanol CTCAE Grades

Data type

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.
Description

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

Data type

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.
Description

Therapeutic procedure Secondary Malignant Neoplasm

Data type

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.
Description

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

Data type

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.
Description

HIV Seropositivity | Hepatitis A | Hepatitis B | Hepatitis C

Data type

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0019159
UMLS CUI [3]
C0019163
UMLS CUI [4]
C0019196
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Similar models

Eligibility Cancer NCT00396864

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Cancer NCT00396864
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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