ID

31188

Beschrijving

Study to Evaluate SID 530 Compared to Taxotere; ODM derived from: https://clinicaltrials.gov/show/NCT00931008

Link

https://clinicaltrials.gov/show/NCT00931008

Trefwoorden

Versies (1)
  1. 25-07-18 25-07-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

25 juli 2018

DOI

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Creative Commons BY 4.0
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Eligibility Non-Small Cell Lung Cancer NCT00931008

Engels

Eligibility Non-Small Cell Lung Cancer NCT00931008

1 Formulieren  
Criteria
Beschrijving

Criteria

has provided written informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
is at least 18 years of age
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
has histologically or cytologically confirmed non-small cell lung (nsclc) or breast cancer (bc) that is locally advanced or metastatic
Beschrijving

Non-Small Cell Lung Carcinoma | Locally advanced breast cancer | Secondary malignant neoplasm of female breast

Datatype

boolean

Alias
UMLS CUI [1]
C0007131
UMLS CUI [2]
C3495949
UMLS CUI [3]
C0346993
has at least two planned consecutive 21-day cycles with 75 mg/m2 docetaxel monotherapy
Beschrijving

Docetaxel Dose Planned

Datatype

boolean

Alias
UMLS CUI [1,1]
C0246415
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1301732
has a life expectancy of at least 3 months
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
has eastern cooperative oncology group performance scale (ecog ps) is in the range of 0-2 at the time of randomization
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
has the proper laboratory values within 1 week prior to randomization
Beschrijving

Laboratory Results

Datatype

boolean

Alias
UMLS CUI [1]
C1254595
has negative serum pregnancy test within 1 week before first study drug administration (for women of childbearing potential, only)
Beschrijving

Childbearing Potential Serum pregnancy test negative

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
is willing to practice medically accepted contraception (if the risk of conception exists) throughout the study period (from screening until the final visit)
Beschrijving

Childbearing Potential Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
exclusion criteria:study participants
Beschrijving

Exclusion Criteria Study Subject

Datatype

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0681850
has had any chemotherapy within 4 weeks before date of first study treatment
Beschrijving

Chemotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C0392920
has experienced severe side effects from (or severe hypersensitivity to) prior docetaxel treatment (or other drugs formulated with polysorbate 80, hydroxypropylbetadex, or povidone) such that discontinuation of the treatment was required
Beschrijving

Adverse effects Severe Docetaxel | Severe allergy Docetaxel | Adverse effects Severe Drug Formulation Polysorbate 80 | Severe allergy Drug Formulation Polysorbate 80 | Adverse effects Severe Hydroxypropyl betadex | Severe allergy Hydroxypropyl betadex | Adverse effects Severe Povidone | Severe allergy Povidone | Treatment Discontinuation Required

Datatype

boolean

Alias
UMLS CUI [1,1]
C0879626
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0246415
UMLS CUI [2,1]
C2945656
UMLS CUI [2,2]
C0246415
UMLS CUI [3,1]
C0879626
UMLS CUI [3,2]
C0205082
UMLS CUI [3,3]
C0524527
UMLS CUI [3,4]
C0032601
UMLS CUI [4,1]
C2945656
UMLS CUI [4,2]
C0524527
UMLS CUI [4,3]
C0032601
UMLS CUI [5,1]
C0879626
UMLS CUI [5,2]
C0205082
UMLS CUI [5,3]
C0046237
UMLS CUI [6,1]
C2945656
UMLS CUI [6,2]
C0046237
UMLS CUI [7,1]
C0879626
UMLS CUI [7,2]
C0205082
UMLS CUI [7,3]
C0032856
UMLS CUI [8,1]
C2945656
UMLS CUI [8,2]
C0032856
UMLS CUI [9,1]
C0087111
UMLS CUI [9,2]
C0457454
UMLS CUI [9,3]
C1514873
has a history of hypersensitivity to dexamethasone
Beschrijving

Dexamethasone allergy

Datatype

boolean

Alias
UMLS CUI [1]
C0571611
is pregnant, lactating, or breastfeeding
Beschrijving

Pregnancy | Lactation | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0022925
UMLS CUI [3]
C0006147
is taking one or more compounds that induce, inhibit, or are metabolized by cytochrome p450 3a4
Beschrijving

CYP3A4 Inducer | CYP3A4 Inhibitor | Other Coding

Datatype

boolean

Alias
UMLS CUI [1]
C3830625
UMLS CUI [2]
C3830624
UMLS CUI [3]
C3846158
has had treatment in another clinical study within the past 30 days
Beschrijving

Study Subject Participation Status | Therapy, Investigational

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0949266
has medical or psychological conditions that would not permit the study participant to complete the study or sign informed consent
Beschrijving

Medical condition Completion of clinical trial Excluded | Medical condition Informed Consent Excluded | Mental condition Completion of clinical trial Excluded | Mental condition Informed Consent Excluded

Datatype

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2732579
UMLS CUI [1,3]
C0332196
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0021430
UMLS CUI [2,3]
C0332196
UMLS CUI [3,1]
C3840291
UMLS CUI [3,2]
C2732579
UMLS CUI [3,3]
C0332196
UMLS CUI [4,1]
C3840291
UMLS CUI [4,2]
C0021430
UMLS CUI [4,3]
C0332196
is unlikely to comply with the protocol requirements, instructions and study-related restrictions
Beschrijving

Protocol Compliance Unlikely

Datatype

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0750558
has any other disease, dysfunction (including alcohol or drug abuse), physical examination or laboratory finding which, in the investigator's opinion, would exclude the participant from the study
Beschrijving

Comorbidity Study Subject Participation Status Excluded | Dysfunction Study Subject Participation Status Excluded | Substance Use Disorders Study Subject Participation Status Excluded | Physical Examination Study Subject Participation Status Excluded | Laboratory finding Study Subject Participation Status Excluded

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0332196
UMLS CUI [2,1]
C3887504
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C0332196
UMLS CUI [3,1]
C0038586
UMLS CUI [3,2]
C2348568
UMLS CUI [3,3]
C0332196
UMLS CUI [4,1]
C0031809
UMLS CUI [4,2]
C2348568
UMLS CUI [4,3]
C0332196
UMLS CUI [5,1]
C0587081
UMLS CUI [5,2]
C2348568
UMLS CUI [5,3]
C0332196
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Similar models

Eligibility Non-Small Cell Lung Cancer NCT00931008

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Informed Consent
Item
has provided written informed consent
boolean
C0021430 (UMLS CUI [1])
Age
Item
is at least 18 years of age
boolean
C0001779 (UMLS CUI [1])
Non-Small Cell Lung Carcinoma | Locally advanced breast cancer | Secondary malignant neoplasm of female breast
Item
has histologically or cytologically confirmed non-small cell lung (nsclc) or breast cancer (bc) that is locally advanced or metastatic
boolean
C0007131 (UMLS CUI [1])
C3495949 (UMLS CUI [2])
C0346993 (UMLS CUI [3])
Docetaxel Dose Planned
Item
has at least two planned consecutive 21-day cycles with 75 mg/m2 docetaxel monotherapy
boolean
C0246415 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
Life Expectancy
Item
has a life expectancy of at least 3 months
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
has eastern cooperative oncology group performance scale (ecog ps) is in the range of 0-2 at the time of randomization
boolean
C1520224 (UMLS CUI [1])
Laboratory Results
Item
has the proper laboratory values within 1 week prior to randomization
boolean
C1254595 (UMLS CUI [1])
Childbearing Potential Serum pregnancy test negative
Item
has negative serum pregnancy test within 1 week before first study drug administration (for women of childbearing potential, only)
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
Childbearing Potential Contraceptive methods
Item
is willing to practice medically accepted contraception (if the risk of conception exists) throughout the study period (from screening until the final visit)
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Exclusion Criteria Study Subject
Item
exclusion criteria:study participants
boolean
C0680251 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
Chemotherapy
Item
has had any chemotherapy within 4 weeks before date of first study treatment
boolean
C0392920 (UMLS CUI [1])
Adverse effects Severe Docetaxel | Severe allergy Docetaxel | Adverse effects Severe Drug Formulation Polysorbate 80 | Severe allergy Drug Formulation Polysorbate 80 | Adverse effects Severe Hydroxypropyl betadex | Severe allergy Hydroxypropyl betadex | Adverse effects Severe Povidone | Severe allergy Povidone | Treatment Discontinuation Required
Item
has experienced severe side effects from (or severe hypersensitivity to) prior docetaxel treatment (or other drugs formulated with polysorbate 80, hydroxypropylbetadex, or povidone) such that discontinuation of the treatment was required
boolean
C0879626 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0246415 (UMLS CUI [1,3])
C2945656 (UMLS CUI [2,1])
C0246415 (UMLS CUI [2,2])
C0879626 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0524527 (UMLS CUI [3,3])
C0032601 (UMLS CUI [3,4])
C2945656 (UMLS CUI [4,1])
C0524527 (UMLS CUI [4,2])
C0032601 (UMLS CUI [4,3])
C0879626 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C0046237 (UMLS CUI [5,3])
C2945656 (UMLS CUI [6,1])
C0046237 (UMLS CUI [6,2])
C0879626 (UMLS CUI [7,1])
C0205082 (UMLS CUI [7,2])
C0032856 (UMLS CUI [7,3])
C2945656 (UMLS CUI [8,1])
C0032856 (UMLS CUI [8,2])
C0087111 (UMLS CUI [9,1])
C0457454 (UMLS CUI [9,2])
C1514873 (UMLS CUI [9,3])
Dexamethasone allergy
Item
has a history of hypersensitivity to dexamethasone
boolean
C0571611 (UMLS CUI [1])
Pregnancy | Lactation | Breast Feeding
Item
is pregnant, lactating, or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0022925 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
CYP3A4 Inducer | CYP3A4 Inhibitor | Other Coding
Item
is taking one or more compounds that induce, inhibit, or are metabolized by cytochrome p450 3a4
boolean
C3830625 (UMLS CUI [1])
C3830624 (UMLS CUI [2])
C3846158 (UMLS CUI [3])
Study Subject Participation Status | Therapy, Investigational
Item
has had treatment in another clinical study within the past 30 days
boolean
C2348568 (UMLS CUI [1])
C0949266 (UMLS CUI [2])
Medical condition Completion of clinical trial Excluded | Medical condition Informed Consent Excluded | Mental condition Completion of clinical trial Excluded | Mental condition Informed Consent Excluded
Item
has medical or psychological conditions that would not permit the study participant to complete the study or sign informed consent
boolean
C3843040 (UMLS CUI [1,1])
C2732579 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0021430 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
C3840291 (UMLS CUI [3,1])
C2732579 (UMLS CUI [3,2])
C0332196 (UMLS CUI [3,3])
C3840291 (UMLS CUI [4,1])
C0021430 (UMLS CUI [4,2])
C0332196 (UMLS CUI [4,3])
Protocol Compliance Unlikely
Item
is unlikely to comply with the protocol requirements, instructions and study-related restrictions
boolean
C0525058 (UMLS CUI [1,1])
C0750558 (UMLS CUI [1,2])
Comorbidity Study Subject Participation Status Excluded | Dysfunction Study Subject Participation Status Excluded | Substance Use Disorders Study Subject Participation Status Excluded | Physical Examination Study Subject Participation Status Excluded | Laboratory finding Study Subject Participation Status Excluded
Item
has any other disease, dysfunction (including alcohol or drug abuse), physical examination or laboratory finding which, in the investigator's opinion, would exclude the participant from the study
boolean
C0009488 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C3887504 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
C0038586 (UMLS CUI [3,1])
C2348568 (UMLS CUI [3,2])
C0332196 (UMLS CUI [3,3])
C0031809 (UMLS CUI [4,1])
C2348568 (UMLS CUI [4,2])
C0332196 (UMLS CUI [4,3])
C0587081 (UMLS CUI [5,1])
C2348568 (UMLS CUI [5,2])
C0332196 (UMLS CUI [5,3])
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