ID

42127

Description

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

Keywords

Versions (4)
  1. 4/14/18 4/14/18 -
  2. 4/14/18 4/14/18 -
  3. 4/13/21 4/13/21 - Dr. rer. medic Philipp Neuhaus
  4. 9/20/21 9/20/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

April 13, 2021

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License

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

English

Screening Eligibility Criteria

1 forms  
Header
Description

Header

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Subject Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Inclusion Criteria
Description

Inclusion Criteria

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

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.
Description

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.

Data type

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.
Description

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

Data type

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)
Description

absence of disease

Data type

boolean

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

ECOG

Data type

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
Description

Bone Marrow function, ANC, Platelet count, Hemoglobin

Data type

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
Description

renal function | creatinine clearance | UPC

Data type

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
Description

hepatic function

Data type

boolean

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

PT | INR | PTT

Data type

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.
Description

age | childbearing potential | contraception

Data type

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
Description

written consent

Data type

boolean

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

Able to swallow and retain oral medication.

Data type

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
Description

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).
Description

GW786034

Data type

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
Description

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

Data type

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
Description

pregnancy or lactation

Data type

boolean

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

compliance contraceptive method

Data type

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)
Description

hypertension | SBP | DBP

Data type

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
Description

QTC prolongation | ECG abnormality

Data type

boolean

Alias
UMLS CUI [1]
C1969409
UMLS CUI [2]
C1832603
Has Class III or IV heart failure as defined by the NYHA functional classification system
Description

heart failure | NYHA

Data type

boolean

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

Cerebrovascular accident

Data type

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.
Description

myocardial infarction | unstable angina | cardiac angioplasty | stent

Data type

boolean

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

venous thrombosis

Data type

boolean

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

warfarin treatment

Data type

boolean

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

leptomeningeal disease | brain metastasis

Data type

boolean

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

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.

Data type

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.
Description

comorbidity

Data type

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.
Description

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

Data type

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.
Description

compliance behaviour

Data type

boolean

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

prohibited medication | GW786034

Data type

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).
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0020517
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Similar models

Screening Eligibility Criteria

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
C1832603 (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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