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])
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])