ID

31188

Descrição

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

Link

https://clinicaltrials.gov/show/NCT00931008

Palavras-chave

Versões (1)
  1. 25.07.18 25.07.18 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

25. Juli 2018

DOI

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Licença

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

Inglês

Eligibility Non-Small Cell Lung Cancer NCT00931008

1 Formulários  
Criteria
Descrição

Criteria

has provided written informed consent
Descrição

Informed Consent

Tipo de dados

boolean

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

Age

Tipo de dados

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
Descrição

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

Tipo de dados

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
Descrição

Docetaxel Dose Planned

Tipo de dados

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
Descrição

Life Expectancy

Tipo de dados

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
Descrição

ECOG performance status

Tipo de dados

boolean

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

Laboratory Results

Tipo de dados

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)
Descrição

Childbearing Potential Serum pregnancy test negative

Tipo de dados

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)
Descrição

Childbearing Potential Contraceptive methods

Tipo de dados

boolean

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

Exclusion Criteria Study Subject

Tipo de dados

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
Descrição

Chemotherapy

Tipo de dados

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
Descrição

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

Tipo de dados

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
Descrição

Dexamethasone allergy

Tipo de dados

boolean

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

Pregnancy | Lactation | Breast Feeding

Tipo de dados

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
Descrição

CYP3A4 Inducer | CYP3A4 Inhibitor | Other Coding

Tipo de dados

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
Descrição

Study Subject Participation Status | Therapy, Investigational

Tipo de dados

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
Descrição

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

Tipo de dados

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
Descrição

Protocol Compliance Unlikely

Tipo de dados

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
Descrição

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

Tipo de dados

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 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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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