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

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Lizenz

Creative Commons BY 4.0

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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])

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