ID
29710
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 (2)
- 4/14/18 4/14/18 -
- 3/15/21 3/15/21 - Dr. rer. medic Philipp Neuhaus
Copyright Holder
GlaxoSmithKline
Uploaded on
April 14, 2018
DOI
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License
Creative Commons BY-NC 3.0
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Oral GW786034 treatment for ovarian cancer NCT00281632
Screening
- StudyEvent: ODM
Description
Eligibility Question
Alias
- UMLS CUI-1
- C1516637
Description
Entry criteria
Data type
boolean
Alias
- UMLS CUI [1]
- C1516637
Description
Demography
Alias
- UMLS CUI-1
- C0011298
Description
Date of Birth
Data type
date
Alias
- UMLS CUI [1]
- C0421451
Description
Must be Female
Data type
text
Alias
- UMLS CUI [1]
- C0079399
Description
Race
Data type
text
Alias
- UMLS CUI [1]
- C0034510
Description
Geographic Ancestry
Data type
text
Alias
- UMLS CUI [1]
- C0034510
Description
Child-bearing Potential: Check one
Data type
text
Alias
- UMLS CUI [1,1]
- C1960468
- UMLS CUI [1,2]
- C0015895
Description
Physical examination
Alias
- UMLS CUI-1
- C0031809
Description
physical examination
Data type
boolean
Alias
- UMLS CUI [1]
- C0031809
Description
Examination Status
Data type
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0449438
Description
physical examination findings
Data type
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0243095
Description
abnormal physical examination
Data type
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0459424
Description
Disease Characteristics
Alias
- UMLS CUI-1
- C1705348
Description
type of primary tumor
Data type
text
Alias
- UMLS CUI [1,1]
- C0449522
- UMLS CUI [1,2]
- C0677930
Description
other primary tumor
Data type
text
Alias
- UMLS CUI [1,1]
- C0449522
- UMLS CUI [1,2]
- C0677930
- UMLS CUI [1,3]
- C0205394
Description
Date of initial diagnosis
Data type
date
Alias
- UMLS CUI [1]
- C2316983
Description
pick one
Data type
text
Alias
- UMLS CUI [1,1]
- C0474935
- UMLS CUI [1,2]
- C4071762
Description
Histology at initial diagnosis
Data type
text
Alias
- UMLS CUI [1,1]
- C0019638
- UMLS CUI [1,2]
- C3172269
Description
Histology other
Data type
text
Alias
- UMLS CUI [1,1]
- C0019638
- UMLS CUI [1,2]
- C0205394
Description
Histological Grade at Initial Diagnosis
Data type
text
Alias
- UMLS CUI [1]
- C0919553
Description
Date of recurrence
Data type
date
Alias
- UMLS CUI [1]
- C3173322
Description
pick one
Data type
text
Alias
- UMLS CUI [1,1]
- C0474935
- UMLS CUI [1,2]
- C1710477
Description
TNM T-Stage ovarian cancer
Data type
text
Alias
- UMLS CUI [1,1]
- C0475455
- UMLS CUI [1,2]
- C0029925
Description
TNM N-Stage ovarian cancer
Data type
text
Alias
- UMLS CUI [1,1]
- C0456532
- UMLS CUI [1,2]
- C0029925
Description
TNM M-Stage ovarian cancer
Data type
text
Alias
- UMLS CUI [1,1]
- C0456533
- UMLS CUI [1,2]
- C0029925
Description
Lines of therapy completed at screening
Data type
text
Alias
- UMLS CUI [1]
- C1514463
Description
Response to Most Recent Prior Therapy
Data type
text
Alias
- UMLS CUI [1,1]
- C0332152
- UMLS CUI [1,2]
- C0871261
Description
Relapsed or Refractory Disease
Data type
text
Alias
- UMLS CUI [1]
- C0205269
- UMLS CUI [2]
- C0277556
Description
If yes, complete below
Data type
boolean
Alias
- UMLS CUI [1]
- C0027627
Description
Date Metastatic Disease First Diagnosed
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0034897
- UMLS CUI [1,3]
- C0012634
Description
Metastatic Disease Site
Alias
- UMLS CUI-1
- C0807944
Description
Metastatic Site
Data type
text
Alias
- UMLS CUI [1]
- C0807944
Description
Is metastatic site
Data type
text
Description
Local Laboratory [Previous CA-125 Values] - Multiple Assessment
Alias
- UMLS CUI-1
- C1254595
Description
Laboratory name
Data type
text
Alias
- UMLS CUI [1]
- C3258037
Description
Laboratory Address
Data type
text
Alias
- UMLS CUI [1,1]
- C1301826
- UMLS CUI [1,2]
- C1882331
Description
For GSK use only
Data type
text
Alias
- UMLS CUI [1,1]
- C0022877
- UMLS CUI [1,2]
- C0600091
Description
Date sample taken
Data type
date
Alias
- UMLS CUI [1]
- C1302413
Description
CA 125
Data type
float
Measurement units
- kU/l
Alias
- UMLS CUI [1]
- C0201549
Description
Residual toxicities related to previous therapy for cancer
Alias
- UMLS CUI-1
- C0920425
- UMLS CUI-2
- C0013221
Description
Residual toxicities
Alias
- UMLS CUI-1
- C0013221
- UMLS CUI-2
- C0220825
Description
Cancer related current medical conditions
Alias
- UMLS CUI-1
- C3899485
Description
Medical Conditions
Alias
- UMLS CUI-1
- C0205476
- UMLS CUI-2
- C0348080
Description
non-cancer related medical conditions
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C1518422
- UMLS CUI-3
- C0006826
- UMLS CUI-4
- C0332281
Description
Medical Conditions
Alias
- UMLS CUI-1
- C0012634
Description
Prior Anti-Cancer Therapy
Alias
- UMLS CUI-1
- C0920425
- UMLS CUI-2
- C1514463
Description
If yes, record each drug
Data type
boolean
Alias
- UMLS CUI [1]
- C0392920
- UMLS CUI [2]
- C0279025
- UMLS CUI [3]
- C1531518
- UMLS CUI [4]
- C0021083
Description
If yes, record details
Data type
boolean
Alias
- UMLS CUI [1]
- C1522449
Description
Prior Anti-Cancer therapy: chemotherapy, hormonal, immunotherapy and/or biologic therapy for the cancer under study?
Alias
- UMLS CUI-1
- C0920425
- UMLS CUI-2
- C0205373
Description
Drug Name
Data type
text
Alias
- UMLS CUI [1]
- C0013227
Description
Regimen Sequence
Data type
integer
Alias
- NCI Thesaurus ObjectClass
- C19464
- NCI Thesaurus ValueDomain
- C25463
- NCI Thesaurus ObjectClass-2
- C49153
- NCI Thesaurus Property
- C25694
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C0392920
Description
Therapy Type
Data type
text
Alias
- UMLS CUI [1,1]
- C0087111
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [2]
- C1514463
Description
Total number of cycles
Data type
integer
Alias
- UMLS CUI [1]
- C2045831
Description
Cycles or Doses
Data type
text
Alias
- UMLS CUI [1]
- C1302181
- UMLS CUI [2]
- C0178602
Description
Total Dose
Data type
float
Alias
- UMLS CUI [1]
- C2986497
Description
dose units
Data type
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C3174092
Description
anti-cancer therapy intent
Data type
text
Alias
- UMLS CUI [1,1]
- C0920425
- UMLS CUI [1,2]
- C1283828
Description
Therapy start date
Data type
date
Alias
- UMLS CUI [1]
- C1531783
Description
Therapy stop date
Data type
date
Alias
- UMLS CUI [1]
- C1531784
Description
Best Tumor Response
Data type
text
Alias
- UMLS CUI [1]
- C2986560
Description
Overall Response Duration
Data type
integer
Measurement units
- weeks
Alias
- UMLS CUI [1]
- C0237585
Description
Prior anti-cancer therapy - radiotherapy
Alias
- UMLS CUI-1
- C1522449
- UMLS CUI-2
- C0920425
Description
Anatomic Site
Data type
text
Alias
- UMLS CUI [1]
- C1515974
Description
Total Dose
Data type
float
Alias
- UMLS CUI [1]
- C2986497
Description
dose units
Data type
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C0034553
Description
anti-cancer therapy intent
Data type
text
Alias
- UMLS CUI [1,1]
- C0920425
- UMLS CUI [1,2]
- C1283828
Description
Therapy start date
Data type
date
Alias
- UMLS CUI [1]
- C1531783
Description
Therapy stop date
Data type
date
Alias
- UMLS CUI [1]
- C1531784
Description
Best Tumor Response
Data type
text
Alias
- UMLS CUI [1]
- C2986560
Description
Overall Response Duration
Data type
integer
Measurement units
- weeks
Alias
- UMLS CUI [1]
- C0237585
Description
Vital signs
Description
Heart rate
Data type
integer
Measurement units
- bpm
Alias
- UMLS CUI [1]
- C0018810
Description
Blood pressure
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0005823
Description
Blood pressure
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0005823
Description
Body weight
Data type
float
Measurement units
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
Body Height
Data type
integer
Measurement units
- cm
Alias
- UMLS CUI [1]
- C0005890
Description
ECOG Performance Status Scale
Alias
- UMLS CUI-1
- C1520224
Description
12 LEAD ECG MONITORING
Alias
- UMLS CUI-1
- C0430456
Description
Time
Data type
time
Alias
- UMLS CUI [1]
- C0040223
Description
Date
Data type
date
Alias
- UMLS CUI [1]
- C0011008
Description
Heart rate
Data type
integer
Measurement units
- bpm
Alias
- UMLS CUI [1]
- C0018810
Description
PR
Data type
float
Measurement units
- msec
Alias
- UMLS CUI [1]
- C0429087
Description
QRS
Data type
float
Measurement units
- msec
Alias
- UMLS CUI [1]
- C1880451
Description
QT
Data type
float
Measurement units
- msec
Alias
- UMLS CUI [1]
- C1287082
Description
QTc
Data type
float
Measurement units
- msec
Alias
- UMLS CUI [1]
- C0489625
Description
Result of the ECG
Data type
text
Alias
- UMLS CUI [1]
- C0438154
Description
12-lead ECG Abnormalities
Alias
- UMLS CUI-1
- C0522055
- UMLS CUI-2
- C0430456
Description
Date of ECG
Data type
date
Alias
- UMLS CUI [1,1]
- C2826640
- UMLS CUI [1,2]
- C0430456
Description
Time of ECG
Data type
time
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1301880
Description
Rhythm Abnormalities
Data type
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0199556
Description
P Wave Morphology Abnormalities
Data type
integer
Alias
- UMLS CUI [1,1]
- C2216025
- UMLS CUI [1,2]
- C0429098
- UMLS CUI [1,3]
- C0430456
Description
P Wave Morphology Abnormalities
Data type
text
Alias
- UMLS CUI [1,1]
- C2216025
- UMLS CUI [1,2]
- C0429098
- UMLS CUI [1,3]
- C0430456
Description
Conduction Abnormalities
Data type
text
Alias
- UMLS CUI [1,1]
- C0232219
- UMLS CUI [1,2]
- C0430456
Description
Myocardial Infarction ECG
Data type
integer
Alias
- UMLS CUI [1,1]
- C3854475
- UMLS CUI [1,2]
- C0430456
Description
Myocardial Infarction ECG
Data type
text
Alias
- UMLS CUI [1,1]
- C3854475
- UMLS CUI [1,2]
- C0430456
Description
Depolarisation/Repolarisation Abnormalities
Data type
text
Alias
- UMLS CUI [1]
- C0948857
Description
12-lead ECG Abnormalities
Data type
text
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C0430456
Description
Rhythm Abnormalities
Data type
integer
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0199556
Description
Conduction Abnormalities
Data type
integer
Alias
- UMLS CUI [1,1]
- C0232219
- UMLS CUI [1,2]
- C0430456
Description
Depolarisation/Repolarisation Abnormalities
Data type
integer
Alias
- UMLS CUI [1]
- C0948857
Description
Local Laboratory - Haematology
Alias
- UMLS CUI-1
- C0474523
- UMLS CUI-2
- C0022885
Description
Lab ID
Data type
text
Alias
- UMLS CUI [1,1]
- C0022877
- UMLS CUI [1,2]
- C0600091
Description
Date Sample taken Haematology
Data type
date
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0018941
- UMLS CUI [1,3]
- C1302413
Description
Haematocrit (HCT)
Data type
float
Alias
- UMLS CUI [1]
- C0018935
Description
Haemoglobin (Hb)
Data type
float
Alias
- UMLS CUI [1]
- C0518015
Description
Platelet count (absolute)
Data type
float
Alias
- UMLS CUI [1]
- C0032181
Description
White blood cell count (WBC) (Absolute)
Data type
float
Alias
- UMLS CUI [1]
- C0023508
Description
Neutrophil count (absolute)
Data type
float
Alias
- UMLS CUI [1]
- C0948762
Description
Lymphocyte count (absolute)
Data type
float
Alias
- UMLS CUI [1]
- C3544087
Description
PTT
Data type
float
Measurement units
- s
Alias
- UMLS CUI [1]
- C0030605
Description
International Normalized Ratio
Data type
float
Alias
- UMLS CUI [1]
- C0525032
Description
Prothrombin time
Data type
float
Alias
- UMLS CUI [1]
- C0033707
Description
Local Laboratory - Clinical Chemistry
Alias
- UMLS CUI-1
- C0008000
- UMLS CUI-2
- C0022885
Description
Lab ID
Data type
integer
Alias
- UMLS CUI [1,1]
- C0022877
- UMLS CUI [1,2]
- C0600091
Description
Date sample taken
Data type
date
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0008000
- UMLS CUI [1,3]
- C1302413
Description
Alkaline phosphatase
Data type
float
Alias
- UMLS CUI [1]
- C0201850
Description
AST (SGOT)
Data type
float
Alias
- UMLS CUI [1]
- C0201899
Description
ALT (SGPT)
Data type
float
Alias
- UMLS CUI [1]
- C0201836
Description
Albumin
Data type
float
Alias
- UMLS CUI [1]
- C0201838
Description
Total bilirubin
Data type
float
Alias
- UMLS CUI [1]
- C0201913
Description
BUN
Data type
float
Alias
- UMLS CUI [1]
- C0005845
Description
Calcium
Data type
float
Alias
- UMLS CUI [1]
- C0201925
Description
Serum Creatinine
Data type
float
Alias
- UMLS CUI [1]
- C0201976
Description
Glucose (fasting)
Data type
float
Alias
- UMLS CUI [1]
- C0583513
Description
LDH
Data type
float
Alias
- UMLS CUI [1]
- C0202113
Description
Potassium
Data type
float
Alias
- UMLS CUI [1]
- C0202194
Description
Sodium
Data type
float
Alias
- UMLS CUI [1]
- C0337443
Description
Lipase
Data type
float
Alias
- UMLS CUI [1]
- C0373670
Description
Amylase
Data type
float
Measurement units
- U/L
Alias
- UMLS CUI [1]
- C0201883
Description
T4
Data type
float
Alias
- UMLS CUI [1]
- C0202231
Description
TSH
Data type
float
Measurement units
- µU/ml
Alias
- UMLS CUI [1]
- C0202230
Description
Urinalysis
Alias
- UMLS CUI-1
- C0042014
Description
Date sample taken
Data type
date
Alias
- UMLS CUI [1]
- C1302413
Description
Laboratory name
Data type
text
Alias
- UMLS CUI [1]
- C3258037
Description
Address
Data type
text
Alias
- UMLS CUI [1,1]
- C1442065
- UMLS CUI [1,2]
- C0022877
Description
UPC ratio
Data type
float
Alias
- UMLS CUI [1,1]
- C1524119
- UMLS CUI [1,2]
- C0033684
- UMLS CUI [1,3]
- C1522609
Description
Lab ID
Data type
text
Alias
- UMLS CUI [1,1]
- C0022877
- UMLS CUI [1,2]
- C0600091
Description
Electronically transferred laboratory data
Alias
- UMLS CUI-1
- C0200345
- UMLS CUI-2
- C0022885
- UMLS CUI-3
- C1320722
Similar models
Screening
- StudyEvent: ODM
C0015895 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,2])
C0459424 (UMLS CUI [1,2])
C0677930 (UMLS CUI [1,2])
C0677930 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C4071762 (UMLS CUI [1,2])
C3172269 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0871261 (UMLS CUI [1,2])
C0277556 (UMLS CUI [2])
C0034897 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
C1882331 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
C0013221 (UMLS CUI-2)
C0013221 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
C1518422 (UMLS CUI-2)
C0006826 (UMLS CUI-3)
C0332281 (UMLS CUI-4)
C3640974 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0006826 (UMLS CUI [1,4])
C1514463 (UMLS CUI-2)
C0279025 (UMLS CUI [2])
C1531518 (UMLS CUI [3])
C0021083 (UMLS CUI [4])
C0205373 (UMLS CUI-2)
C25463 (NCI Thesaurus ValueDomain)
C49153 (NCI Thesaurus ObjectClass-2)
C25694 (NCI Thesaurus Property)
C2348184 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2])
C3174092 (UMLS CUI [1,2])
C0920425 (UMLS CUI-2)
C0430456 (UMLS CUI-2)
C0430456 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
C0199556 (UMLS CUI [1,3])
C0429098 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,3])
C0429098 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,3])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
C0199556 (UMLS CUI [1,3])
C0430456 (UMLS CUI [1,2])
C0022885 (UMLS CUI-2)
C0600091 (UMLS CUI [1,2])
C0018941 (UMLS CUI [1,2])
C1302413 (UMLS CUI [1,3])
C0022885 (UMLS CUI-2)
C0600091 (UMLS CUI [1,2])
C0008000 (UMLS CUI [1,2])
C1302413 (UMLS CUI [1,3])
C0022877 (UMLS CUI [1,2])
C0033684 (UMLS CUI [1,2])
C1522609 (UMLS CUI [1,3])
C0600091 (UMLS CUI [1,2])
C0022885 (UMLS CUI-2)
C1320722 (UMLS CUI-3)
C0201549 (UMLS CUI [1,2])
C0201549 (UMLS CUI [1,2])