ID

31335

Beskrivning

MLN8237 for Treatment of Patients With Ovarian, Fallopian Tube, or Peritoneal Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00853307

Länk

https://clinicaltrials.gov/show/NCT00853307

Nyckelord

Versioner (1)
  1. 2018-08-14 2018-08-14 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

14 augusti 2018

DOI

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Creative Commons BY 4.0
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Eligibility Ovarian Carcinoma NCT00853307

Engelsk

Eligibility Ovarian Carcinoma NCT00853307

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. female patients 18 years or older
Beskrivning

Gender | Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
2. histologically or cytologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
Beskrivning

Epithelial ovarian cancer | Fallopian Tube Carcinoma | Primary peritoneal carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0677886
UMLS CUI [2]
C0238122
UMLS CUI [3]
C1514428
3. eastern cooperative oncology group performance status 0 or 1
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
4. postmenopausal at least 1 year, or
Beskrivning

Postmenopausal state

Datatyp

boolean

Alias
UMLS CUI [1]
C0232970
surgically sterile, or
Beskrivning

Female Sterilization

Datatyp

boolean

Alias
UMLS CUI [1]
C0015787
if childbearing potential, agree to 2 effective methods of nonhormonal contraception, or agree to completely abstain from heterosexual intercourse
Beskrivning

Childbearing Potential Contraceptive methods | Exception Hormonal contraception | Childbearing Potential Sexual Abstinence

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C2985296
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0036899
5. able to provide written informed consent.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
6. within 7 days before study:
Beskrivning

Status pre- Clinical Trial

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332152
UMLS CUI [1,2]
C0008976
absolute neutrophils (anc) ≥ 1,500/μl
Beskrivning

Absolute neutrophil count

Datatyp

boolean

Alias
UMLS CUI [1]
C0948762
platelets ≥100,000/ μl
Beskrivning

Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0032181
total bilirubin must be < 1.5 times upper limit of the normal (uln)
Beskrivning

Serum total bilirubin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C1278039
alanine aminotransferase (alt) or aspartate aminotransferase (ast) must be ≤ 2.5 times the uln. ast and alt may be elevated up to 5 times the uln if ascribed to metastatic liver disease.
Beskrivning

Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Aspartate aminotransferase increased | Alanine aminotransferase increased | Relationship Secondary malignant neoplasm of liver

Datatyp

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0151904
UMLS CUI [4]
C0151905
UMLS CUI [5,1]
C0439849
UMLS CUI [5,2]
C0494165
creatinine clearance ≥ 30 ml/minute
Beskrivning

Creatinine clearance measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0373595
7. platinum-refractory or -resistant disease
Beskrivning

Platinum Refractory Disease | Disease Resistant Platinum

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0032207
UMLS CUI [1,2]
C1514815
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0332325
UMLS CUI [2,3]
C0032207
8. measurable disease by response evaluation criteria in solid tumors (recist) or ca 125 level of > 40 units/ml and clinical evidence disease
Beskrivning

Measurable Disease | CA 125 measurement | Evidence Clinical Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C0201549
UMLS CUI [3,1]
C3887511
UMLS CUI [3,2]
C0205210
UMLS CUI [3,3]
C0012634
9. recovered from effects of prior therapy
Beskrivning

Effects of Prior Therapy Patient recovered

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1704420
UMLS CUI [1,2]
C1514463
UMLS CUI [1,3]
C1115804
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. pregnant or lactating
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
2. serious illness that could interfere with protocol completion
Beskrivning

Illness Serious Interferes with Completion of clinical trial

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C2732579
3. investigational treatment 28 days prior to first dose.
Beskrivning

Therapy, Investigational

Datatyp

boolean

Alias
UMLS CUI [1]
C0949266
4. maximum 4 prior systemic therapies: 2 platinum-based, 1 nonplatinum cytotoxic, 1 biological
Beskrivning

Systemic therapy Quantity Maximum | Systemic therapy Platinum-Based Quantity | Systemic therapy cytotoxic Quantity | Systemic therapy biological Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0806909
UMLS CUI [2,1]
C1515119
UMLS CUI [2,2]
C1514162
UMLS CUI [2,3]
C1265611
UMLS CUI [3,1]
C1515119
UMLS CUI [3,2]
C1511636
UMLS CUI [3,3]
C1265611
UMLS CUI [4,1]
C1515119
UMLS CUI [4,2]
C0205460
UMLS CUI [4,3]
C1265611
5. known central nervous system metastases
Beskrivning

CNS metastases

Datatyp

boolean

Alias
UMLS CUI [1]
C0686377
6. prior allogeneic bone marrow or organ transplantation
Beskrivning

Allogeneic bone marrow transplantation | Organ Transplantation Allogeneic

Datatyp

boolean

Alias
UMLS CUI [1]
C0149615
UMLS CUI [2,1]
C0029216
UMLS CUI [2,2]
C1515895
7. radiotherapy within 21 days prior to first dose
Beskrivning

Therapeutic radiology procedure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0005953
UMLS CUI [1,3]
C0439165
8. radiotherapy to > 25% bone marrow
Beskrivning

Therapeutic radiology procedure Bone Marrow Percentage

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0005953
UMLS CUI [1,3]
C0439165
9. major surgery, infection requiring systemic antibiotic therapy within 14 days prior to first dose
Beskrivning

Major surgery | Communicable Disease Requirement Antibiotic therapy Systemic

Datatyp

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0338237
UMLS CUI [2,4]
C0205373
10. inability to swallow orally administered medication
Beskrivning

Lacking Able to swallow Oral medication

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C2712086
UMLS CUI [1,3]
C0175795
11. diagnosis or treatment of another malignancy within 2 years preceding first dose of study drug except nonmelanoma skin cancer or in situ malignancy completely resected
Beskrivning

Cancer Other | Exception Skin carcinoma | Exception Complete excision Carcinoma in Situ

Datatyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0015250
UMLS CUI [3,3]
C0007099
12. known history of human immunodeficiency virus (hiv) infection, hepatitis b, or hepatitis c.
Beskrivning

HIV Infection | Hepatitis B | Hepatitis C

Datatyp

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
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Similar models

Eligibility Ovarian Carcinoma NCT00853307

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
1. female patients 18 years or older
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Epithelial ovarian cancer | Fallopian Tube Carcinoma | Primary peritoneal carcinoma
Item
2. histologically or cytologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
boolean
C0677886 (UMLS CUI [1])
C0238122 (UMLS CUI [2])
C1514428 (UMLS CUI [3])
ECOG performance status
Item
3. eastern cooperative oncology group performance status 0 or 1
boolean
C1520224 (UMLS CUI [1])
Postmenopausal state
Item
4. postmenopausal at least 1 year, or
boolean
C0232970 (UMLS CUI [1])
Female Sterilization
Item
surgically sterile, or
boolean
C0015787 (UMLS CUI [1])
Childbearing Potential Contraceptive methods | Exception Hormonal contraception | Childbearing Potential Sexual Abstinence
Item
if childbearing potential, agree to 2 effective methods of nonhormonal contraception, or agree to completely abstain from heterosexual intercourse
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C2985296 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0036899 (UMLS CUI [3,2])
Informed Consent
Item
5. able to provide written informed consent.
boolean
C0021430 (UMLS CUI [1])
Status pre- Clinical Trial
Item
6. within 7 days before study:
boolean
C0332152 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Absolute neutrophil count
Item
absolute neutrophils (anc) ≥ 1,500/μl
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelets ≥100,000/ μl
boolean
C0032181 (UMLS CUI [1])
Serum total bilirubin measurement
Item
total bilirubin must be < 1.5 times upper limit of the normal (uln)
boolean
C1278039 (UMLS CUI [1])
Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Aspartate aminotransferase increased | Alanine aminotransferase increased | Relationship Secondary malignant neoplasm of liver
Item
alanine aminotransferase (alt) or aspartate aminotransferase (ast) must be ≤ 2.5 times the uln. ast and alt may be elevated up to 5 times the uln if ascribed to metastatic liver disease.
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
C0151905 (UMLS CUI [4])
C0439849 (UMLS CUI [5,1])
C0494165 (UMLS CUI [5,2])
Creatinine clearance measurement
Item
creatinine clearance ≥ 30 ml/minute
boolean
C0373595 (UMLS CUI [1])
Platinum Refractory Disease | Disease Resistant Platinum
Item
7. platinum-refractory or -resistant disease
boolean
C0032207 (UMLS CUI [1,1])
C1514815 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C0332325 (UMLS CUI [2,2])
C0032207 (UMLS CUI [2,3])
Measurable Disease | CA 125 measurement | Evidence Clinical Disease
Item
8. measurable disease by response evaluation criteria in solid tumors (recist) or ca 125 level of > 40 units/ml and clinical evidence disease
boolean
C1513041 (UMLS CUI [1])
C0201549 (UMLS CUI [2])
C3887511 (UMLS CUI [3,1])
C0205210 (UMLS CUI [3,2])
C0012634 (UMLS CUI [3,3])
Effects of Prior Therapy Patient recovered
Item
9. recovered from effects of prior therapy
boolean
C1704420 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C1115804 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
1. pregnant or lactating
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Illness Serious Interferes with Completion of clinical trial
Item
2. serious illness that could interfere with protocol completion
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C2732579 (UMLS CUI [1,4])
Therapy, Investigational
Item
3. investigational treatment 28 days prior to first dose.
boolean
C0949266 (UMLS CUI [1])
Systemic therapy Quantity Maximum | Systemic therapy Platinum-Based Quantity | Systemic therapy cytotoxic Quantity | Systemic therapy biological Quantity
Item
4. maximum 4 prior systemic therapies: 2 platinum-based, 1 nonplatinum cytotoxic, 1 biological
boolean
C1515119 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C1515119 (UMLS CUI [2,1])
C1514162 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C1515119 (UMLS CUI [3,1])
C1511636 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C1515119 (UMLS CUI [4,1])
C0205460 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
CNS metastases
Item
5. known central nervous system metastases
boolean
C0686377 (UMLS CUI [1])
Allogeneic bone marrow transplantation | Organ Transplantation Allogeneic
Item
6. prior allogeneic bone marrow or organ transplantation
boolean
C0149615 (UMLS CUI [1])
C0029216 (UMLS CUI [2,1])
C1515895 (UMLS CUI [2,2])
Therapeutic radiology procedure
Item
7. radiotherapy within 21 days prior to first dose
boolean
C1522449 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
Therapeutic radiology procedure Bone Marrow Percentage
Item
8. radiotherapy to > 25% bone marrow
boolean
C1522449 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
Major surgery | Communicable Disease Requirement Antibiotic therapy Systemic
Item
9. major surgery, infection requiring systemic antibiotic therapy within 14 days prior to first dose
boolean
C0679637 (UMLS CUI [1])
C0009450 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0338237 (UMLS CUI [2,3])
C0205373 (UMLS CUI [2,4])
Lacking Able to swallow Oral medication
Item
10. inability to swallow orally administered medication
boolean
C0332268 (UMLS CUI [1,1])
C2712086 (UMLS CUI [1,2])
C0175795 (UMLS CUI [1,3])
Cancer Other | Exception Skin carcinoma | Exception Complete excision Carcinoma in Situ
Item
11. diagnosis or treatment of another malignancy within 2 years preceding first dose of study drug except nonmelanoma skin cancer or in situ malignancy completely resected
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0015250 (UMLS CUI [3,2])
C0007099 (UMLS CUI [3,3])
HIV Infection | Hepatitis B | Hepatitis C
Item
12. known history of human immunodeficiency virus (hiv) infection, hepatitis b, or hepatitis c.
boolean
C0019693 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
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