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44142

Beschreibung

Study ID: 104450 Clinical Study ID: VEG104450 Study Title: This study is a non-randomized, open-label, multi-center Phase II study of GW786034 to evaluate the administration of oral GW786034 in subjects with ovarian cancer. Clinicaltrials.gov Identifier: NCT00281632 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: pazopanib Trade Name: Votrient Study Indication: Neoplasms, Ovarian CRF Pages: 722-853

Stichworte

Versionen (4)
  1. 2018-04-14 2018-04-14 -
  2. 2018-04-14 2018-04-14 -
  3. 2021-04-13 2021-04-13 - Dr. rer. medic Philipp Neuhaus
  4. 2021-09-20 2021-09-20 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

20 september 2021

DOI

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Creative Commons BY-NC 3.0
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    Oral GW786034 treatment for ovarian cancer NCT00281632

    Englisch

    Screening Eligibility Criteria

    1 Formulare  
    Header
    Beschreibung

    Header

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Beschreibung

    Subject Identifier

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2348585
    Inclusion Criteria
    Beschreibung

    Inclusion Criteria

    Alias
    UMLS CUI-1
    C1512693
    Has histologically or cytologically confirmed diagnosis of epithelial ovarian, fallopian tube or primary peritoneal carcinoma.
    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0029925
    UMLS CUI [1,2]
    C0205225
    UMLS CUI [2]
    C1514428
    UMLS CUI [3]
    C0238122
    Has recieved 2 or less prior regimens. The first regimen must have been a platinum-based (cisplatin, carboplatin, or oxaliplatin) chemotherapy.
    Beschreibung

    Note: > Subjects who have received consolidation (maintenance) chemotherapy following their first-line treatment are eligible for this study. > Subjects who have received tamoxifen are eligible for this study > Neoadjuvant and adjuvant would be considered one line of therapy. > Subjects who have received monoclonal antibody therapy that target CA-125 (Ovarex) are eligible provided they have a rising CA-125.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1514457
    UMLS CUI [2,1]
    C0392920
    UMLS CUI [2,2]
    C1514162
    Has had a prior complete CA-125 response as determined by a normalized CA-125 value following first-line platinum based therapy that has subsequently risen to more than 42 U/mL.
    Beschreibung

    Note: Inclusion criteria is based upon the upper limit of normal (CA-125 < 21 U/mL) of the central laboratory.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0201549
    Has no evidence of disease following radiographic evaluation by baseline scans OR Has non-bulky, non-measurable disease (e.g., minimal ascites which does not cause abdominal distention or require paracentesis, mesenteric thickening or masses of 4 cm or less by CT or MRI as documented on baseline scans)
    Beschreibung

    absence of disease

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0009488
    Has ECOG Performance Status of 0 or 1.
    Beschreibung

    ECOG

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    Adequate bone marrow function as determined by the following tests: Absolute neutrophil count (ANC) > 1,500/mm³ Platelet count > 100,000/mm³ Hemoglobin > 9mg/dL
    Beschreibung

    Bone Marrow function, ANC, Platelet count, Hemoglobin

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0005953
    UMLS CUI [1,2]
    C0031843
    UMLS CUI [2]
    C0948762
    UMLS CUI [3]
    C0032181
    UMLS CUI [4]
    C0019046
    Adequate renal function as determined by the following tests: > Creatinine clearance > 40 mL/min > Urine Proteine Clearance (UPC) ratio > 1
    Beschreibung

    renal function | creatinine clearance | UPC

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0232804
    UMLS CUI [2]
    C0373595
    UMLS CUI [3,1]
    C1524119
    UMLS CUI [3,2]
    C0033684
    UMLS CUI [3,3]
    C1522609
    adequate hepatic function as defined by bilirubin < 1.5 x the upper limit of normal (uln) and aspartate aminotransferase (ast) and alanine aminotransferase (alt) < 2.5 x uln
    Beschreibung

    hepatic function

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1278039
    UMLS CUI [2]
    C0201836
    UMLS CUI [3]
    C0201899
    PT/INR/PTT < 1.2 times upper limit of normal
    Beschreibung

    PT | INR | PTT

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0033707
    UMLS CUI [2]
    C0525032
    UMLS CUI [3]
    C0030605
    Subject is eligible to enter and participate in the study if she is at least 21 years of age and of non-childbearing potential or of childbearing potential with negative pregnancy test and agrees to specified methods of contraception.
    Beschreibung

    age | childbearing potential | contraception

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    UMLS CUI [2]
    C3831118
    UMLS CUI [3]
    C0700589
    Has provided a signed and dated written informed consent (obtained from subject or the subject's legally acceptable represantative prior to screening
    Beschreibung

    written consent

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Able to swallow and retain oral medication.
    Beschreibung

    Able to swallow and retain oral medication.

    Datentyp

    boolean

    Alias
    SNOMED CT 2011_0131
    288936000
    SNOMED CT 2011_0131-2
    371150009
    SNOMED CT 2011_0131-3
    397909002
    UMLS CUI [1,1]
    C2712086
    UMLS CUI [1,2]
    C0175795
    UMLS CUI [2,1]
    C0175795
    UMLS CUI [2,2]
    C0333118
    UMLS CUI [2,3]
    C0085732
    Exclusion Criteria
    Beschreibung

    Exclusion Criteria

    Alias
    UMLS CUI-1
    C0680251
    Has received prior therapy with GW786034 or any other aniogenesis inhibitors (i.e., bevacizumab, small molecule tyrosine kinase inhibitor).
    Beschreibung

    GW786034

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1327963
    UMLS CUI [2]
    C0596087
    Has had any major surgery, chemotherapy, hormonal therapy, biologic, immunotherapy, or radiotherapy within the last 28 days and has not recovered from such prior therapy
    Beschreibung

    major surgery | chemotherapy | hormonal therapy | biologic therapy | immunotherapy | radiotherapy

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0679637
    UMLS CUI [2]
    C0392920
    UMLS CUI [3]
    C0279025
    UMLS CUI [4]
    C1531518
    UMLS CUI [5,1]
    C0021083
    UMLS CUI [5,2]
    C1522449
    Is pregnant or lactating
    Beschreibung

    pregnancy or lactation

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    Is of childbearing potential and does not agree to use an effective contraceptive method
    Beschreibung

    compliance contraceptive method

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0700589
    UMLS CUI [1,2]
    C0525058
    Has poorly controlled hypertension (SBP 140 mmHg or higher, or DBP 90 mmHg or higher)
    Beschreibung

    hypertension | SBP | DBP

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1868885
    UMLS CUI [2]
    C0871470
    UMLS CUI [3]
    C0428883
    Has QTc prolongation defined as QTc interval > 480 msec or other clinically significant ECG abnormalities
    Beschreibung

    QTC prolongation | ECG abnormality

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1969409
    UMLS CUI [2]
    C0522055
    Has Class III or IV heart failure as defined by the NYHA functional classification system
    Beschreibung

    heart failure | NYHA

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0018801
    UMLS CUI [2]
    C1275491
    Has a history of cerebrovascular accident (CVA) within the past 6 months.
    Beschreibung

    Cerebrovascular accident

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0038454
    Has a history of myocardial infarction, admission for unstable angina, cardiac angioplasty or stenting within the past 3 months.
    Beschreibung

    myocardial infarction | unstable angina | cardiac angioplasty | stent

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0027051
    UMLS CUI [2]
    C0002965
    UMLS CUI [3]
    C0027056
    UMLS CUI [4]
    C0038257
    Has an untreated venous thrombosis.
    Beschreibung

    venous thrombosis

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0042487
    Is currently taking therapeutic doses of warfarin.
    Beschreibung

    warfarin treatment

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0043031
    Has a history of leptomeningeal disease or brain metastasis.
    Beschreibung

    leptomeningeal disease | brain metastasis

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1704231
    UMLS CUI [2]
    C0220650
    History of other malignancy.
    Beschreibung

    Note: Subjects who have had another malignancy and have been disease-free for 3 years or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible.

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0262926
    UMLS CUI [1,2]
    C0006826
    Has any serious and/or unstable pre-existing medical, psychiatric, or other condition (including lab abnormalities) that could interfere with subject's safety or the ability to obtain informed consent.
    Beschreibung

    comorbidity

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0009488
    Has a history of malabsorption syndome, disease significantly affecting gastrointestinal function or major resection of the stomach or proximal small bowel resection that could affect absorption, distribution, metabolism or excretion of study drug or has any unresolved bowel obstruction or diarrhea.
    Beschreibung

    Malabsorption Syndrome | Disease Affecting gastrointestinal function | Gastric Bypass | Excision Stomach | Small intestine excision | Inflammatory Bowel Diseases Symptomatic | Partial bowel obstruction | Intestinal Obstruction Complete

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0024523
    UMLS CUI [2,1]
    C0012634
    UMLS CUI [2,2]
    C0392760
    UMLS CUI [2,3]
    C0516983
    UMLS CUI [3]
    C0017125
    UMLS CUI [4,1]
    C0728940
    UMLS CUI [4,2]
    C0038351
    UMLS CUI [5]
    C0192601
    UMLS CUI [6,1]
    C0021390
    UMLS CUI [6,2]
    C0231220
    UMLS CUI [7]
    C1328480
    UMLS CUI [8,1]
    C0021843
    UMLS CUI [8,2]
    C0205197
    Has a psychological, familial, sociological, or geographical condition(s) that does not permit compliance with the protocol.
    Beschreibung

    compliance behaviour

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1321605
    Is on any specifically prohibited medication(s) or requires any of these medications during treatment with GW786034
    Beschreibung

    prohibited medication | GW786034

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0683610
    UMLS CUI [2]
    C1327963
    Has known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to study drug or the excipients of the study drug compound: microcrystalline cellulose, povidone K30, sodium starch glycolate, magnesium stearate, or opadry white (OY—S-9603).
    Beschreibung

    microcrystalline cellulose hypersensitivity, povidone K30 hypersensitivity, sodium starch glycolate hypersensitivity, magnesium stearate hypersensitivity, or opadry white hypersensitivity

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0020517
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Screening Eligibility Criteria

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Header
    C1320722 (UMLS CUI-1)
    Subject Identifier
    Item
    Subject Identifier
    text
    C2348585 (UMLS CUI [1])
    Item Group
    Inclusion Criteria
    C1512693 (UMLS CUI-1)
    confirmed diagnosis of epithelial ovarian, fallopian tube or primary peritoneal carcinoma
    Item
    Has histologically or cytologically confirmed diagnosis of epithelial ovarian, fallopian tube or primary peritoneal carcinoma.
    boolean
    C0029925 (UMLS CUI [1,1])
    C0205225 (UMLS CUI [1,2])
    C1514428 (UMLS CUI [2])
    C0238122 (UMLS CUI [3])
    prior regimens, platinum based chemotherapy
    Item
    Has recieved 2 or less prior regimens. The first regimen must have been a platinum-based (cisplatin, carboplatin, or oxaliplatin) chemotherapy.
    boolean
    C1514457 (UMLS CUI [1])
    C0392920 (UMLS CUI [2,1])
    C1514162 (UMLS CUI [2,2])
    CA-125 response
    Item
    Has had a prior complete CA-125 response as determined by a normalized CA-125 value following first-line platinum based therapy that has subsequently risen to more than 42 U/mL.
    boolean
    C0201549 (UMLS CUI [1])
    absence of disease
    Item
    Has no evidence of disease following radiographic evaluation by baseline scans OR Has non-bulky, non-measurable disease (e.g., minimal ascites which does not cause abdominal distention or require paracentesis, mesenteric thickening or masses of 4 cm or less by CT or MRI as documented on baseline scans)
    boolean
    C0009488 (UMLS CUI [1])
    ECOG
    Item
    Has ECOG Performance Status of 0 or 1.
    boolean
    C1520224 (UMLS CUI [1])
    Bone Marrow function, ANC, Platelet count, Hemoglobin
    Item
    Adequate bone marrow function as determined by the following tests: Absolute neutrophil count (ANC) > 1,500/mm³ Platelet count > 100,000/mm³ Hemoglobin > 9mg/dL
    boolean
    C0005953 (UMLS CUI [1,1])
    C0031843 (UMLS CUI [1,2])
    C0948762 (UMLS CUI [2])
    C0032181 (UMLS CUI [3])
    C0019046 (UMLS CUI [4])
    renal function | creatinine clearance | UPC
    Item
    Adequate renal function as determined by the following tests: > Creatinine clearance > 40 mL/min > Urine Proteine Clearance (UPC) ratio > 1
    boolean
    C0232804 (UMLS CUI [1])
    C0373595 (UMLS CUI [2])
    C1524119 (UMLS CUI [3,1])
    C0033684 (UMLS CUI [3,2])
    C1522609 (UMLS CUI [3,3])
    hepatic function
    Item
    adequate hepatic function as defined by bilirubin < 1.5 x the upper limit of normal (uln) and aspartate aminotransferase (ast) and alanine aminotransferase (alt) < 2.5 x uln
    boolean
    C1278039 (UMLS CUI [1])
    C0201836 (UMLS CUI [2])
    C0201899 (UMLS CUI [3])
    PT | INR | PTT
    Item
    PT/INR/PTT < 1.2 times upper limit of normal
    boolean
    C0033707 (UMLS CUI [1])
    C0525032 (UMLS CUI [2])
    C0030605 (UMLS CUI [3])
    age | childbearing potential | contraception
    Item
    Subject is eligible to enter and participate in the study if she is at least 21 years of age and of non-childbearing potential or of childbearing potential with negative pregnancy test and agrees to specified methods of contraception.
    boolean
    C0001779 (UMLS CUI [1])
    C3831118 (UMLS CUI [2])
    C0700589 (UMLS CUI [3])
    written consent
    Item
    Has provided a signed and dated written informed consent (obtained from subject or the subject's legally acceptable represantative prior to screening
    boolean
    C0021430 (UMLS CUI [1])
    Able to swallow and retain oral medication.
    Item
    Able to swallow and retain oral medication.
    boolean
    288936000 (SNOMED CT 2011_0131)
    371150009 (SNOMED CT 2011_0131-2)
    397909002 (SNOMED CT 2011_0131-3)
    C2712086 (UMLS CUI [1,1])
    C0175795 (UMLS CUI [1,2])
    C0175795 (UMLS CUI [2,1])
    C0333118 (UMLS CUI [2,2])
    C0085732 (UMLS CUI [2,3])
    Item Group
    Exclusion Criteria
    C0680251 (UMLS CUI-1)
    GW786034
    Item
    Has received prior therapy with GW786034 or any other aniogenesis inhibitors (i.e., bevacizumab, small molecule tyrosine kinase inhibitor).
    boolean
    C1327963 (UMLS CUI [1])
    C0596087 (UMLS CUI [2])
    major surgery | chemotherapy | hormonal therapy | biologic therapy | immunotherapy | radiotherapy
    Item
    Has had any major surgery, chemotherapy, hormonal therapy, biologic, immunotherapy, or radiotherapy within the last 28 days and has not recovered from such prior therapy
    boolean
    C0679637 (UMLS CUI [1])
    C0392920 (UMLS CUI [2])
    C0279025 (UMLS CUI [3])
    C1531518 (UMLS CUI [4])
    C0021083 (UMLS CUI [5,1])
    C1522449 (UMLS CUI [5,2])
    pregnancy or lactation
    Item
    Is pregnant or lactating
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    compliance contraceptive method
    Item
    Is of childbearing potential and does not agree to use an effective contraceptive method
    boolean
    C0700589 (UMLS CUI [1,1])
    C0525058 (UMLS CUI [1,2])
    hypertension | SBP | DBP
    Item
    Has poorly controlled hypertension (SBP 140 mmHg or higher, or DBP 90 mmHg or higher)
    boolean
    C1868885 (UMLS CUI [1])
    C0871470 (UMLS CUI [2])
    C0428883 (UMLS CUI [3])
    QTC prolongation | ECG abnormality
    Item
    Has QTc prolongation defined as QTc interval > 480 msec or other clinically significant ECG abnormalities
    boolean
    C1969409 (UMLS CUI [1])
    C0522055 (UMLS CUI [2])
    heart failure | NYHA
    Item
    Has Class III or IV heart failure as defined by the NYHA functional classification system
    boolean
    C0018801 (UMLS CUI [1])
    C1275491 (UMLS CUI [2])
    Cerebrovascular accident
    Item
    Has a history of cerebrovascular accident (CVA) within the past 6 months.
    boolean
    C0038454 (UMLS CUI [1])
    myocardial infarction | unstable angina | cardiac angioplasty | stent
    Item
    Has a history of myocardial infarction, admission for unstable angina, cardiac angioplasty or stenting within the past 3 months.
    boolean
    C0027051 (UMLS CUI [1])
    C0002965 (UMLS CUI [2])
    C0027056 (UMLS CUI [3])
    C0038257 (UMLS CUI [4])
    venous thrombosis
    Item
    Has an untreated venous thrombosis.
    boolean
    C0042487 (UMLS CUI [1])
    warfarin treatment
    Item
    Is currently taking therapeutic doses of warfarin.
    boolean
    C0043031 (UMLS CUI [1])
    leptomeningeal disease | brain metastasis
    Item
    Has a history of leptomeningeal disease or brain metastasis.
    boolean
    C1704231 (UMLS CUI [1])
    C0220650 (UMLS CUI [2])
    other malignancy medical history
    Item
    History of other malignancy.
    boolean
    C0262926 (UMLS CUI [1,1])
    C0006826 (UMLS CUI [1,2])
    comorbidity
    Item
    Has any serious and/or unstable pre-existing medical, psychiatric, or other condition (including lab abnormalities) that could interfere with subject's safety or the ability to obtain informed consent.
    boolean
    C0009488 (UMLS CUI [1])
    Malabsorption Syndrome | Disease Affecting gastrointestinal function | Gastric Bypass | Excision Stomach | Small intestine excision | Inflammatory Bowel Diseases Symptomatic | Partial bowel obstruction | Intestinal Obstruction Complete
    Item
    Has a history of malabsorption syndome, disease significantly affecting gastrointestinal function or major resection of the stomach or proximal small bowel resection that could affect absorption, distribution, metabolism or excretion of study drug or has any unresolved bowel obstruction or diarrhea.
    boolean
    C0024523 (UMLS CUI [1])
    C0012634 (UMLS CUI [2,1])
    C0392760 (UMLS CUI [2,2])
    C0516983 (UMLS CUI [2,3])
    C0017125 (UMLS CUI [3])
    C0728940 (UMLS CUI [4,1])
    C0038351 (UMLS CUI [4,2])
    C0192601 (UMLS CUI [5])
    C0021390 (UMLS CUI [6,1])
    C0231220 (UMLS CUI [6,2])
    C1328480 (UMLS CUI [7])
    C0021843 (UMLS CUI [8,1])
    C0205197 (UMLS CUI [8,2])
    compliance behaviour
    Item
    Has a psychological, familial, sociological, or geographical condition(s) that does not permit compliance with the protocol.
    boolean
    C1321605 (UMLS CUI [1])
    prohibited medication | GW786034
    Item
    Is on any specifically prohibited medication(s) or requires any of these medications during treatment with GW786034
    boolean
    C0013227 (UMLS CUI [1,1])
    C0683610 (UMLS CUI [1,2])
    C1327963 (UMLS CUI [2])
    microcrystalline cellulose hypersensitivity, povidone K30 hypersensitivity, sodium starch glycolate hypersensitivity, magnesium stearate hypersensitivity, or opadry white hypersensitivity
    Item
    Has known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to study drug or the excipients of the study drug compound: microcrystalline cellulose, povidone K30, sodium starch glycolate, magnesium stearate, or opadry white (OY—S-9603).
    boolean
    C0020517 (UMLS CUI [1])
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