Eligibility
Study Procedures
Investigational Product
Vendors
Miscellaneous
100
Biomarker used in pre/Screening
What is HA?
100
National Park in downtown Washington, DC
What is the National Mall?
100
3.0 mcg/kg and 1200 mg
What are the doses of PEGPH20 and Atezolizumab?
100
Central lab that will be sending all lab kits to sites and storing samples until transfer to analytical labs for analysis.
What is ICON?
100
Registering of a subject.
What is entering the subject into IWRS in Screening?
200
1 or more measurable lesions
What is the required CT/MRI scan per RECIST 1.1?
200
Performed within 7 days prior to C1D1
What is the serum/urine pregnancy test for WCBP?
200
PEGCISGEM, PEGCISGEMATEZO and CISGEM
What are the 3 arms in the Expansion portion of the study?
200
All lab samples will be sent back to ICON once collected except this lab.
What is Ventana?
200
Month projected to enroll/dose 1st subject
What is Oct 2017?
300
Specific event that starts the screening window clock (28 days).
What is signing the main ICF
300
PE, ECOG, labs (multiple), Vital signs, Wt/BSA
What are the assessments performed on C1D1 before PEGPH20 infusion
300
Drug given prior to PEGPH20 administration for MSEs
What is Piroxicam?
300
The year Washington DC became the US capital
What is 1790?
300
Prescreening ICF and Main ICF consent options
What is sequential ICF consenting or simultaneous ICF consenting
400
Number of museums in the Smithsonian.
What are 19 museums and galleries?
400
Performed every 3rd treatment cycle (3, 6, 9 etc.)
What are CT/MRI scans?
400
Administered to the patient every day for TE prophylaxis
What is Enoxaparin?
400
Analysis of CT/MRI scans.
What is local site read of CT/MRI scans?
400
GEM is anticipated to be missed, held, or permanently discontinued.
What is the hold or discontinuation of Cisplatin?
500
Drug that is prohibited in this study
What is Megace?
500
Blood assay samples that are collected only for the PEGCISGEMATEZO arm?
What are Thyroid Function Tests?
500
The length of time for PEGPH20 IV infusion
What is 10-12 minutes?
500
Safety lab that is done most frequently during the study.
What is Hematology?
500
Used in screening to check lower extremities for DLTs
What is a Doppler ultrasound?
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