0 Ratings
ID

38231

Description

A Study of Capecitabine Rapid Disintegrating Tablets (RDT) Versus Commercial Xeloda in Patients With Solid Tumours; ODM derived from: https://clinicaltrials.gov/show/NCT01493336

Link

https://clinicaltrials.gov/show/NCT01493336

Keywords

Versions (1)
  1. 9/30/19 9/30/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 30, 2019

DOI

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License

Creative Commons BY 4.0
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    Eligibility Breast Cancer, Colorectal Cancer NCT01493336

    English

    Eligibility Breast Cancer, Colorectal Cancer NCT01493336

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    adult patients,>/= 18 years of age
    Description

    Adult | Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001675
    UMLS CUI [2]
    C0001779
    histological/cytological confirmation of colorectal or breast cancer
    Description

    Colorectal Carcinoma | Breast Carcinoma

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0009402
    UMLS CUI [2]
    C0678222
    patient is ambulatory and has a karnofsky performance status of > 70%
    Description

    Patient Ambulatory | Karnofsky Performance Status

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0030705
    UMLS CUI [1,2]
    C0439841
    UMLS CUI [2]
    C0206065
    body surface area between 1.5 and 2.0 m2
    Description

    Body Surface Area

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0005902
    either:
    Description

    Either

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3844638
    due to receive xeloda as monotherapy or as combination therapy as per their treating physician's treatment plan, or
    Description

    Etiology | Xeloda | Combined Modality Therapy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0015127
    UMLS CUI [2]
    C0724419
    UMLS CUI [3]
    C0009429
    currently receiving xeloda monotherapy and in the investigator's opinion able to tolerate study drug dose on day 1 and day 2
    Description

    Xeloda | Ability Receive Investigational New Drugs

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0724419
    UMLS CUI [2,1]
    C0085732
    UMLS CUI [2,2]
    C1514756
    UMLS CUI [2,3]
    C0013230
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    any contraindication to xeloda
    Description

    Medical contraindication Xeloda

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1301624
    UMLS CUI [1,2]
    C0724419
    received xeloda in the 6 days prior to day 1
    Description

    Xeloda Received Recently

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0724419
    UMLS CUI [1,2]
    C1514756
    UMLS CUI [1,3]
    C0332185
    subjects with organ allografts (other than autologous bone marrow transplant after high dose chemotherapy)
    Description

    Organ allografts | Exception Autologous bone marrow transplant Post High-dose chemotherapy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0178784
    UMLS CUI [1,2]
    C0040739
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C0194037
    UMLS CUI [2,3]
    C0687676
    UMLS CUI [2,4]
    C1328050
    renal impairment
    Description

    Renal Insufficiency

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1565489
    pregnant or lactating females
    Description

    Pregnancy | Breast Feeding

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    participation in an investigational drug study within 28 days prior to screening
    Description

    Study Subject Participation Status | Investigational New Drugs

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    UMLS CUI [2]
    C0013230
    lack of physical integrity of the upper gastrointestinal tract, or clinically significant malabsorption syndrome
    Description

    Lacking Integrity Upper Gastrointestinal Tract | Malabsorption Syndrome

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0332268
    UMLS CUI [1,2]
    C1947912
    UMLS CUI [1,3]
    C3203348
    UMLS CUI [2]
    C0024523
    serious uncontrolled intercurrent infections
    Description

    Communicable Diseases Serious Uncontrolled

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0009450
    UMLS CUI [1,2]
    C0205404
    UMLS CUI [1,3]
    C0205318
    history of clinically significant coronary artery disease
    Description

    Coronary Artery Disease

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1956346
    concomitant treatment with warfarin
    Description

    Warfarin therapy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C4303340
    known dihydropyrimidine dehydrogenase deficiency
    Description

    Dihydropyrimidine Dehydrogenase Deficiency

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1959620
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    Similar models

    Eligibility Breast Cancer, Colorectal Cancer NCT01493336

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Adult | Age
    Item
    adult patients,>/= 18 years of age
    boolean
    C0001675 (UMLS CUI [1])
    C0001779 (UMLS CUI [2])
    Colorectal Carcinoma | Breast Carcinoma
    Item
    histological/cytological confirmation of colorectal or breast cancer
    boolean
    C0009402 (UMLS CUI [1])
    C0678222 (UMLS CUI [2])
    Patient Ambulatory | Karnofsky Performance Status
    Item
    patient is ambulatory and has a karnofsky performance status of > 70%
    boolean
    C0030705 (UMLS CUI [1,1])
    C0439841 (UMLS CUI [1,2])
    C0206065 (UMLS CUI [2])
    Body Surface Area
    Item
    body surface area between 1.5 and 2.0 m2
    boolean
    C0005902 (UMLS CUI [1])
    Either
    Item
    either:
    boolean
    C3844638 (UMLS CUI [1])
    Etiology | Xeloda | Combined Modality Therapy
    Item
    due to receive xeloda as monotherapy or as combination therapy as per their treating physician's treatment plan, or
    boolean
    C0015127 (UMLS CUI [1])
    C0724419 (UMLS CUI [2])
    C0009429 (UMLS CUI [3])
    Xeloda | Ability Receive Investigational New Drugs
    Item
    currently receiving xeloda monotherapy and in the investigator's opinion able to tolerate study drug dose on day 1 and day 2
    boolean
    C0724419 (UMLS CUI [1])
    C0085732 (UMLS CUI [2,1])
    C1514756 (UMLS CUI [2,2])
    C0013230 (UMLS CUI [2,3])
    Item Group
    C0680251 (UMLS CUI)
    Medical contraindication Xeloda
    Item
    any contraindication to xeloda
    boolean
    C1301624 (UMLS CUI [1,1])
    C0724419 (UMLS CUI [1,2])
    Xeloda Received Recently
    Item
    received xeloda in the 6 days prior to day 1
    boolean
    C0724419 (UMLS CUI [1,1])
    C1514756 (UMLS CUI [1,2])
    C0332185 (UMLS CUI [1,3])
    Organ allografts | Exception Autologous bone marrow transplant Post High-dose chemotherapy
    Item
    subjects with organ allografts (other than autologous bone marrow transplant after high dose chemotherapy)
    boolean
    C0178784 (UMLS CUI [1,1])
    C0040739 (UMLS CUI [1,2])
    C1705847 (UMLS CUI [2,1])
    C0194037 (UMLS CUI [2,2])
    C0687676 (UMLS CUI [2,3])
    C1328050 (UMLS CUI [2,4])
    Renal Insufficiency
    Item
    renal impairment
    boolean
    C1565489 (UMLS CUI [1])
    Pregnancy | Breast Feeding
    Item
    pregnant or lactating females
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    Study Subject Participation Status | Investigational New Drugs
    Item
    participation in an investigational drug study within 28 days prior to screening
    boolean
    C2348568 (UMLS CUI [1])
    C0013230 (UMLS CUI [2])
    Lacking Integrity Upper Gastrointestinal Tract | Malabsorption Syndrome
    Item
    lack of physical integrity of the upper gastrointestinal tract, or clinically significant malabsorption syndrome
    boolean
    C0332268 (UMLS CUI [1,1])
    C1947912 (UMLS CUI [1,2])
    C3203348 (UMLS CUI [1,3])
    C0024523 (UMLS CUI [2])
    Communicable Diseases Serious Uncontrolled
    Item
    serious uncontrolled intercurrent infections
    boolean
    C0009450 (UMLS CUI [1,1])
    C0205404 (UMLS CUI [1,2])
    C0205318 (UMLS CUI [1,3])
    Coronary Artery Disease
    Item
    history of clinically significant coronary artery disease
    boolean
    C1956346 (UMLS CUI [1])
    Warfarin therapy
    Item
    concomitant treatment with warfarin
    boolean
    C4303340 (UMLS CUI [1])
    Dihydropyrimidine Dehydrogenase Deficiency
    Item
    known dihydropyrimidine dehydrogenase deficiency
    boolean
    C1959620 (UMLS CUI [1])
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