ID

41170

Beschrijving

Assess Safety & Efficacy of Selumetinib When Given in Combination With Standard First Line Treatment for Advanced Non-small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01809210

Link

https://clinicaltrials.gov/show/NCT01809210

Trefwoorden

Versies (1)
  1. 04-07-20 04-07-20 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

4 juli 2020

DOI

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Licentie

Creative Commons BY-NC 4.0
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Eligibility Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIB IV; NCT01809210

Engels

Eligibility Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIB IV; NCT01809210

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
provision of signed, written and dated consent prior to any study specific procedures
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
male or female, aged 18 years or older
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
histological or cytological confirmation of locally advanced or metastatic nsclc (iiib-iv)
Beschrijving

Locally Advanced Lung Non-Small Cell Carcinoma TNM clinical staging | Metastatic non-small cell lung cancer TNM clinical staging

Datatype

boolean

Alias
UMLS CUI [1,1]
C5205550
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C0278987
UMLS CUI [2,2]
C3258246
female patients must not be breast-feeding and have a negative pregnancy test prior to start of dosing or must have evidence of non-child-bearing potential
Beschrijving

Gender Breast Feeding Absent | Gender Pregnancy test negative | Childbearing Potential Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0006147
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0427780
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0332197
patients must be eligible to receive treatment with the platinum doublet combination with which selumetinib is being combined and in accordance with the local product information
Beschrijving

Platinum Doublet | Selumetinib | Combined Modality Therapy

Datatype

boolean

Alias
UMLS CUI [1]
C5206469
UMLS CUI [2]
C2980074
UMLS CUI [3]
C0009429
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior chemotherapy or other systemic anti-cancer treatment for advanced nsclc.
Beschrijving

Prior Chemotherapy Advanced Lung Non-Small Cell Carcinoma | Cancer treatment Systemic Advanced Lung Non-Small Cell Carcinoma

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C5206378
UMLS CUI [2,1]
C0920425
UMLS CUI [2,2]
C0205373
UMLS CUI [2,3]
C5206378
prior surgery or radiotherapy within 6 months or palliative radiotherapy within 4 weeks of start of study treatment.
Beschrijving

Operative Surgical Procedure Recent | Therapeutic radiology procedure Recent | Palliative course of radiotherapy Recent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0332185
UMLS CUI [3,1]
C0475092
UMLS CUI [3,2]
C0332185
female patients who are breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control
Beschrijving

Breast Feeding | Females & males of reproductive potential Contraceptive methods Absent

Datatype

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2,1]
C4034483
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0332197
another primary malignancy within 5 years of starting study treatment, except for adequately treated basal or squamous cell carcinoma of the skin or cancer of the cervix in situ.
Beschrijving

Cancer Other | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated

Datatype

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
UMLS CUI [4,3]
C1522326
as judged by the investigator, any evidence of severe or uncontrolled systemic diseases, active bleeding diatheses, renal transplant, or active infection
Beschrijving

Systemic disease Severe | Systemic disease Uncontrolled | Bleeding tendency | Kidney Transplantation | Communicable Disease

Datatype

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0442893
UMLS CUI [2,2]
C0205318
UMLS CUI [3]
C1458140
UMLS CUI [4]
C0022671
UMLS CUI [5]
C0009450
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Similar models

Eligibility Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIB IV; NCT01809210

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
provision of signed, written and dated consent prior to any study specific procedures
boolean
C0021430 (UMLS CUI [1])
Age
Item
male or female, aged 18 years or older
boolean
C0001779 (UMLS CUI [1])
Locally Advanced Lung Non-Small Cell Carcinoma TNM clinical staging | Metastatic non-small cell lung cancer TNM clinical staging
Item
histological or cytological confirmation of locally advanced or metastatic nsclc (iiib-iv)
boolean
C5205550 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0278987 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
Gender Breast Feeding Absent | Gender Pregnancy test negative | Childbearing Potential Absent
Item
female patients must not be breast-feeding and have a negative pregnancy test prior to start of dosing or must have evidence of non-child-bearing potential
boolean
C0079399 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2,1])
C0427780 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Platinum Doublet | Selumetinib | Combined Modality Therapy
Item
patients must be eligible to receive treatment with the platinum doublet combination with which selumetinib is being combined and in accordance with the local product information
boolean
C5206469 (UMLS CUI [1])
C2980074 (UMLS CUI [2])
C0009429 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Prior Chemotherapy Advanced Lung Non-Small Cell Carcinoma | Cancer treatment Systemic Advanced Lung Non-Small Cell Carcinoma
Item
prior chemotherapy or other systemic anti-cancer treatment for advanced nsclc.
boolean
C1514457 (UMLS CUI [1,1])
C5206378 (UMLS CUI [1,2])
C0920425 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C5206378 (UMLS CUI [2,3])
Operative Surgical Procedure Recent | Therapeutic radiology procedure Recent | Palliative course of radiotherapy Recent
Item
prior surgery or radiotherapy within 6 months or palliative radiotherapy within 4 weeks of start of study treatment.
boolean
C0543467 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
C0475092 (UMLS CUI [3,1])
C0332185 (UMLS CUI [3,2])
Breast Feeding | Females & males of reproductive potential Contraceptive methods Absent
Item
female patients who are breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control
boolean
C0006147 (UMLS CUI [1])
C4034483 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Cancer Other | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated
Item
another primary malignancy within 5 years of starting study treatment, except for adequately treated basal or squamous cell carcinoma of the skin or cancer of the cervix in situ.
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
Systemic disease Severe | Systemic disease Uncontrolled | Bleeding tendency | Kidney Transplantation | Communicable Disease
Item
as judged by the investigator, any evidence of severe or uncontrolled systemic diseases, active bleeding diatheses, renal transplant, or active infection
boolean
C0442893 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0442893 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C1458140 (UMLS CUI [3])
C0022671 (UMLS CUI [4])
C0009450 (UMLS CUI [5])
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