ID

14957

Beschreibung

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

Stichworte

  1. 09.05.16 09.05.16 -
Hochgeladen am

9. Mai 2016

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0

Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Itemgroup Kommentare für :

Item Kommentare für :


    Keine Kommentare

    Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

    Eligibility Advanced Solid Tumors NCT01520389

    Eligibility Advanced Solid Tumors NCT01520389

    Inclusion Criteria
    Beschreibung

    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
    Beschreibung

    solid tumor

    Datentyp

    boolean

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

    age

    Datentyp

    boolean

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

    informed consent

    Datentyp

    boolean

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

    measurable tumor

    Datentyp

    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
    Beschreibung

    patients must be recovered

    Datentyp

    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)
    Beschreibung

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

    Datentyp

    boolean

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

    Exclusion Criteria

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

    curative antineoplastic therapy

    Datentyp

    boolean

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

    pregnant or lactating

    Datentyp

    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.)
    Beschreibung

    active infection

    Datentyp

    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
    Beschreibung

    cns malignancies

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0348374

    Ähnliche Modelle

    Eligibility Advanced Solid Tumors NCT01520389

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    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])

    Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

    Mit * gekennzeichnete Felder sind notwendig.

    Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

    Zum Video