0 Avaliações

ID

14957

Descrição

Safety Study of the Drug MM-151 in Patients With Advanced Solid Tumors Resisting Ordinary Treatment; ODM derived from: https://clinicaltrials.gov/show/NCT01520389

Link

https://clinicaltrials.gov/show/NCT01520389

Palavras-chave

  1. 09/05/2016 09/05/2016 -
Transferido a

9 de maio de 2016

DOI

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Licença

Creative Commons BY 4.0

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    Eligibility Advanced Solid Tumors NCT01520389

    Eligibility Advanced Solid Tumors NCT01520389

    Inclusion Criteria
    Descrição

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    patients must have histologically or cytologically confirmed advanced malignant solid tumor that has recurred or progressed following standard therapy, or that has not responded to standard therapy, or for which there is no standard therapy, or who are not candidates for standard therapy
    Descrição

    solid tumor

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0280100
    patients must be > 18 years of age
    Descrição

    age

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    patients of their legal representatives must be able to understand and sign an informed consent form
    Descrição

    informed consent

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    patients must have evaluable or measurable tumor(s)
    Descrição

    measurable tumor

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1302351
    patients must be recovered from the effects of any prior surgery, radiotherapy or other antineoplastic therapy. up to ctcae grade 1 is acceptable for patients with known peripheral neuropathy
    Descrição

    patients must be recovered

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C2004454
    women of childbearing potential as well as fertile men and their partners must agree to abstain from sexual intercourse or to use an effective form of contraception during the study and for 90 days following the last dose of mm-151 (an effective form of contraception is an oral contraceptive or a double barrier method)
    Descrição

    abstain from sexual intercourse or to use an effective form of contraception

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1171321
    UMLS CUI [2]
    C0700589
    Exclusion Criteria
    Descrição

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    patients for whom potentially curative antineoplastic therapy is available
    Descrição

    curative antineoplastic therapy

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C2346834
    UMLS CUI [1,2]
    C1273390
    patients who are pregnant or lactating
    Descrição

    pregnant or lactating

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0032961
    UMLS CUI [1,2]
    C0006147
    patients with an active infection or with an unexplained fever > 38.5°c during screening visits or on the first scheduled day of dosing. (at the discretion of the investigator, patients with tumor fever may be enrolled.)
    Descrição

    active infection

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0009450
    patients with untreated and/or symptomatic cns malignancies (primary or metastatic); patients with cns metastases who have undergone surgery or radiotherapy, whose disease is stable, and who have been on a stable dose of corticosteroids for at least 2 weeks prior to the first scheduled day of dosing will be eligible for the trial
    Descrição

    cns malignancies

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0348374

    Similar models

    Eligibility Advanced Solid Tumors NCT01520389

    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    C1512693 (UMLS CUI)
    solid tumor
    Item
    patients must have histologically or cytologically confirmed advanced malignant solid tumor that has recurred or progressed following standard therapy, or that has not responded to standard therapy, or for which there is no standard therapy, or who are not candidates for standard therapy
    boolean
    C0280100 (UMLS CUI [1])
    age
    Item
    patients must be > 18 years of age
    boolean
    C0001779 (UMLS CUI [1])
    informed consent
    Item
    patients of their legal representatives must be able to understand and sign an informed consent form
    boolean
    C0021430 (UMLS CUI [1])
    measurable tumor
    Item
    patients must have evaluable or measurable tumor(s)
    boolean
    C1302351 (UMLS CUI [1])
    patients must be recovered
    Item
    patients must be recovered from the effects of any prior surgery, radiotherapy or other antineoplastic therapy. up to ctcae grade 1 is acceptable for patients with known peripheral neuropathy
    boolean
    C2004454 (UMLS CUI [1])
    abstain from sexual intercourse or to use an effective form of contraception
    Item
    women of childbearing potential as well as fertile men and their partners must agree to abstain from sexual intercourse or to use an effective form of contraception during the study and for 90 days following the last dose of mm-151 (an effective form of contraception is an oral contraceptive or a double barrier method)
    boolean
    C1171321 (UMLS CUI [1])
    C0700589 (UMLS CUI [2])
    Item Group
    C0680251 (UMLS CUI)
    curative antineoplastic therapy
    Item
    patients for whom potentially curative antineoplastic therapy is available
    boolean
    C2346834 (UMLS CUI [1,1])
    C1273390 (UMLS CUI [1,2])
    pregnant or lactating
    Item
    patients who are pregnant or lactating
    boolean
    C0032961 (UMLS CUI [1,1])
    C0006147 (UMLS CUI [1,2])
    active infection
    Item
    patients with an active infection or with an unexplained fever > 38.5°c during screening visits or on the first scheduled day of dosing. (at the discretion of the investigator, patients with tumor fever may be enrolled.)
    boolean
    C0009450 (UMLS CUI [1])
    cns malignancies
    Item
    patients with untreated and/or symptomatic cns malignancies (primary or metastatic); patients with cns metastases who have undergone surgery or radiotherapy, whose disease is stable, and who have been on a stable dose of corticosteroids for at least 2 weeks prior to the first scheduled day of dosing will be eligible for the trial
    boolean
    C0348374 (UMLS CUI [1])

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